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    Clinical Trial Results:
    A Phase 2, Randomized, Double-Blind, Placebo Controlled, Dose Ranging, Dose Finding, Parallel Group Study to Assess Efficacy and Safety of PF-07081532, And Open Label Oral Semaglutide, In Adults with Type 2 Diabetes Mellitus (T2DM) Inadequately Controlled on Metformin, And Separately PF-07081532 Compared to Matching Placebo in Adults with Obesity but Without T2DM.

    Summary
    EudraCT number
    2022-002834-15
    Trial protocol
    CZ   HU   BG  
    Global end of trial date
    22 Sep 2023

    Results information
    Results version number
    v1(current)
    This version publication date
    27 Sep 2024
    First version publication date
    27 Sep 2024
    Other versions

    Trial information

    Close Top of page
    Trial identification
    Sponsor protocol code
    C3991004
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT05579977
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Pfizer Inc.
    Sponsor organisation address
    235 E 42nd Street, New York, United States, NY 10017
    Public contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    26 Jan 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Sep 2023
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of a range of PF-07081532 doses compared to placebo, in subjects with T2DM inadequately controlled on metformin and subjects with obesity but without T2DM.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Council for Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trials subjects were followed.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    27 Oct 2022
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Canada: 95
    Country: Number of subjects enrolled
    Czechia: 22
    Country: Number of subjects enrolled
    Hungary: 90
    Country: Number of subjects enrolled
    Japan: 97
    Country: Number of subjects enrolled
    Puerto Rico: 29
    Country: Number of subjects enrolled
    Bulgaria: 34
    Country: Number of subjects enrolled
    Poland: 89
    Country: Number of subjects enrolled
    United States: 445
    Worldwide total number of subjects
    901
    EEA total number of subjects
    235
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    683
    From 65 to 84 years
    218
    85 years and over
    0

    Subject disposition

    Close Top of page
    Recruitment
    Recruitment details
    This study had 2 cohorts: Cohort 1 included subjects with type 2 diabetes mellitus (T2DM) on a background therapy of metformin. Cohort 2 included subjects with obesity But without T2DM.

    Pre-assignment
    Screening details
    A total of 902 subjects were randomized in this study of which 1 subject did not receive treatment. The study was terminated based on pharmacokinetic data from Phase 1 drug-drug-interaction studies and laboratory measurements of elevated transaminases in these Phase 1 studies as well as this Phase 2 study.

    Period 1
    Period 1 title
    Treatment Phase
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Investigator, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo (T2DM)
    Arm description
    Subjects randomized to receive a single dose of PF-07081532-matching placebo once daily (QD) orally.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received placebo tablets orally QD.

    Arm title
    PF-07081532 20mg (T2DM)
    Arm description
    Subjects randomized to receive PF-07081532 20 mg QD orally.
    Arm type
    Experimental

    Investigational medicinal product name
    PF-07081532
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    PF-07081532 was available as tablets at unit dose strength of 20, 60 and 100 mg to be administered orally QD at the desired dose levels.

    Arm title
    PF-07081532 40mg (T2DM)
    Arm description
    Subjects with T2DM inadequately controlled with metformin were administered PF-07081532 20 mg QD orally for 4 weeks followed by PF-07081532 40 mg QD orally.
    Arm type
    Experimental

    Investigational medicinal product name
    PF-07081532
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    PF-07081532 was available as tablets at unit dose strength of 20, 60 and 100 mg to be administered orally QD at the desired dose levels.

    Arm title
    PF-07081532 80mg (T2DM)
    Arm description
    Subjects with T2DM inadequately controlled with metformin were administered titrating doses of PF-07081532 20 mg QD, 40 mg QD and 60 mg QD orally for 4 weeks each followed by PF-07081532 80 mg QD orally.
    Arm type
    Experimental

    Investigational medicinal product name
    PF-07081532
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    PF-07081532 was available as tablets at unit dose strength of 20, 60 and 100 mg to be administered orally QD at the desired dose levels.

    Arm title
    PF-07081532 160mg (T2DM)
    Arm description
    Subjects with T2DM inadequately controlled with metformin were administered titrating doses of PF-07081532 20 mg QD 40 mg QD, 60 mg QD, 80 mg QD and 120 mg QD orally for 4 weeks each followed by PF-07081532 160 mg QD orally.
    Arm type
    Experimental

    Investigational medicinal product name
    PF-07081532
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    PF-07081532 was available as tablets at unit dose strength of 20, 60 and 100 mg to be administered orally QD at the desired dose levels.

    Arm title
    PF-07081532 260mg (T2DM)
    Arm description
    Subjects with T2DM inadequately controlled with metformin were administered titrating doses of PF-07081532 20 mg QD, 40 mg QD, 80 mg QD, 140 mg QD and 200 mg QD orally for 4 weeks each followed by PF-07081532 260 mg QD orally.
    Arm type
    Experimental

    Investigational medicinal product name
    PF-07081532
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    PF-07081532 was available as tablets at unit dose strength of 20, 60 and 100 mg to be administered orally QD at the desired dose levels.

    Arm title
    Rybelsus 14mg (T2DM)
    Arm description
    Subjects with T2DM inadequately controlled with metformin were administered titrating doses of Rybelsus 3 mg QD and 7 mg QD each for 4 weeks followed by 14 mg QD.
    Arm type
    Experimental

    Investigational medicinal product name
    Rybelsus
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Rybelsus was available as tablets at unit dose strength of 3, 7 and 14 mg to be administered orally QD at the desired dose levels.

    Arm title
    Placebo (Obesity)
    Arm description
    Subjects randomized to receive a single dose of PF-07081532-matching placebo QD orally.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received placebo tablets orally QD.

    Arm title
    PF-07081532 80mg (Obesity)
    Arm description
    Subjects with obesity were administered titrating doses of PF-07081532 20 mg QD, 40 mg QD and 60 mg QD orally for 4 weeks each followed by PF-07081532 80 mg QD orally.
    Arm type
    Experimental

    Investigational medicinal product name
    PF-07081532
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    PF-07081532 was available as tablets at unit dose strength of 20, 60 and 100 mg to be administered orally QD at the desired dose levels.

    Arm title
    PF-07081532 140mg (Obesity)
    Arm description
    Subjects with obesity were administered titrating doses of PF-07081532 20 mg QD, 40 mg QD and 60 mg QD, 80 mg QD, 120 mg QD orally for 4 weeks each followed by PF-07081532 140 mg QD orally.
    Arm type
    Experimental

    Investigational medicinal product name
    PF-07081532
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    PF-07081532 was available as tablets at unit dose strength of 20, 60 and 100 mg to be administered orally QD at the desired dose levels.

    Arm title
    PF-07081532 200mg (Obesity,5 steps)
    Arm description
    Subjects with obesity were administered titrating doses of PF-07081532 20 mg QD, 40 mg QD and 60 mg QD, 100 mg QD, 160 mg QD orally for 4 weeks each followed by PF-07081532 200 mg QD orally.
    Arm type
    Experimental

    Investigational medicinal product name
    PF-07081532
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    PF-07081532 was available as tablets at unit dose strength of 20, 60 and 100 mg to be administered orally QD at the desired dose levels.

    Arm title
    PF-07081532 200mg (Obesity,4 steps)
    Arm description
    Subjects with obesity were administered titrating doses of PF-07081532 20 mg QD, 40 mg QD and 80 mg QD, 140 mg QD orally for 4 weeks each followed by PF-07081532 200 mg QD orally.
    Arm type
    Experimental

    Investigational medicinal product name
    PF-07081532
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    PF-07081532 was available as tablets at unit dose strength of 20, 60 and 100 mg to be administered orally QD at the desired dose levels.

    Arm title
    PF-07081532 260mg (Obesity)
    Arm description
    Subjects with obesity were administered titrating doses of PF-07081532 20 mg QD, 40 mg QD and 80 mg QD, 140 mg QD, 200 mg QD orally for 4 weeks each followed by PF-07081532 260 mg QD orally.
    Arm type
    Experimental

    Investigational medicinal product name
    PF-07081532
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    PF-07081532 was available as tablets at unit dose strength of 20, 60 and 100 mg to be administered orally QD at the desired dose levels.

    Number of subjects in period 1
    Placebo (T2DM) PF-07081532 20mg (T2DM) PF-07081532 40mg (T2DM) PF-07081532 80mg (T2DM) PF-07081532 160mg (T2DM) PF-07081532 260mg (T2DM) Rybelsus 14mg (T2DM) Placebo (Obesity) PF-07081532 80mg (Obesity) PF-07081532 140mg (Obesity) PF-07081532 200mg (Obesity,5 steps) PF-07081532 200mg (Obesity,4 steps) PF-07081532 260mg (Obesity)
    Started
    75
    73
    72
    73
    72
    74
    73
    64
    66
    64
    65
    66
    64
    Completed
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Not completed
    75
    73
    72
    73
    72
    74
    73
    64
    66
    64
    65
    66
    64
         Consent withdrawn by subject
    2
    -
    -
    1
    2
    -
    1
    8
    3
    3
    5
    1
    3
         Physician decision
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    1
    -
         Adverse event, non-fatal
    -
    3
    11
    10
    5
    17
    5
    5
    12
    20
    15
    24
    23
         Death
    1
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
         Pregnancy
    -
    -
    -
    -
    -
    -
    -
    -
    -
    1
    -
    -
    -
         Study terminated by sponsor
    70
    70
    61
    59
    63
    53
    66
    48
    47
    37
    44
    36
    32
         Unspecified
    -
    -
    -
    2
    1
    2
    1
    2
    2
    1
    -
    -
    3
         Lost to follow-up
    -
    -
    -
    1
    1
    1
    -
    1
    2
    2
    1
    4
    3
         Treatment with restricted medication needed
    2
    -
    -
    -
    -
    1
    -
    -
    -
    -
    -
    -
    -
    Period 2
    Period 2 title
    Follow up Phase
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator

    Arms
    Are arms mutually exclusive
    No

    Arm title
    Placebo (T2DM)
    Arm description
    Subjects randomized to receive a single dose of PF-07081532-matching placebo once daily (QD) orally.
    Arm type
    No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    PF-07081532 20mg (T2DM)
    Arm description
    Subjects randomized to receive PF-07081532 20 mg QD orally.
    Arm type
    No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    PF-07081532 40mg (T2DM)
    Arm description
    Subjects randomized to receive PF-07081532 20 mg QD orally for 4 weeks, followed by 40 mg QD orally.
    Arm type
    No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    PF-07081532 80mg (T2DM)
    Arm description
    Subjects randomized to receive PF-07081532 20 mg QD, 40 mg QD and 60 mg QD orally for 4 weeks, followed by PF-07081532 80 mg QD orally.
    Arm type
    No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    PF-07081532 160mg (T2DM)
    Arm description
    Subjects randomized to receive PF-07081532 20 mg QD 40 mg QD, 60 mg QD, 80 mg QD and 120 mg QD orally for 4 weeks, followed by PF-07081532 160 mg QD orally.
    Arm type
    No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    PF-07081532 260mg (T2DM)
    Arm description
    Subjects randomized to receive PF-07081532 20 mg QD, 40 mg QD, 80 mg QD, 140 mg QD and 200 mg QD orally for 4 weeks, followed by PF-07081532 260 mg QD orally.
    Arm type
    No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    Rybelsus 14mg (T2DM)
    Arm description
    Subjects randomized to receive Rybelsus 3 mg QD and 7 mg QD each for 4 weeks followed by 14 mg QD.
    Arm type
    No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    Placebo (Obesity)
    Arm description
    Subjects randomized to receive a single dose of PF-07081532-matching placebo QD orally.
    Arm type
    No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    PF-07081532 80mg (Obesity)
    Arm description
    Subjects randomized to receive PF-07081532 20 mg QD, 40 mg QD and 60 mg QD orally for 4 weeks, followed by PF-07081532 80 mg QD orally.
    Arm type
    No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    PF-07081532 140mg (Obesity)
    Arm description
    Subjects randomized to receive PF-07081532 20 mg QD, 40 mg QD and 60 mg QD, 80 mg QD,120 mg QD orally for 4 weeks each followed by PF-07081532 140 mg QD orally.
    Arm type
    No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    PF-07081532 200mg (Obesity,5 steps)
    Arm description
    Subjects randomized to receive PF-07081532 20 mg QD, 40 mg QD and 60 mg QD, 100 mg QD,160 mg QD orally for 4 weeks each followed by PF-07081532 200 mg QD orally.
    Arm type
    No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    PF-07081532 200mg (Obesity,4 steps)
    Arm description
    Subjects randomized to receive PF-07081532 20 mg QD, 40 mg QD and 80 mg QD, 140 mg QD orally for 4 weeks each followed by PF-07081532 200 mg QD orally.
    Arm type
    No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    PF-07081532 260mg (Obesity)
    Arm description
    Subjects randomized to receive PF-07081532 20 mg QD, 40 mg QD and 80 mg QD, 140 mg QD, 200 mg QD orally for 4 weeks each followed by PF-07081532 260 mg QD orally.
    Arm type
    No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 2
    Placebo (T2DM) PF-07081532 20mg (T2DM) PF-07081532 40mg (T2DM) PF-07081532 80mg (T2DM) PF-07081532 160mg (T2DM) PF-07081532 260mg (T2DM) Rybelsus 14mg (T2DM) Placebo (Obesity) PF-07081532 80mg (Obesity) PF-07081532 140mg (Obesity) PF-07081532 200mg (Obesity,5 steps) PF-07081532 200mg (Obesity,4 steps) PF-07081532 260mg (Obesity)
    Started
    75
    73
    72
    73
    72
    74
    73
    64
    66
    64
    65
    66
    64
    Completed
    72
    73
    72
    72
    70
    72
    71
    59
    61
    59
    60
    61
    57
    Not completed
    3
    0
    0
    1
    2
    2
    2
    5
    5
    5
    5
    5
    7
         Consent withdrawn by subject
    2
    -
    -
    -
    1
    -
    1
    4
    2
    3
    3
    1
    3
         Death
    1
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
         Lost to follow-up
    -
    -
    -
    1
    1
    2
    1
    1
    3
    2
    2
    4
    4

    Baseline characteristics

    Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Placebo (T2DM)
    Reporting group description
    Subjects randomized to receive a single dose of PF-07081532-matching placebo once daily (QD) orally.

    Reporting group title
    PF-07081532 20mg (T2DM)
    Reporting group description
    Subjects randomized to receive PF-07081532 20 mg QD orally.

    Reporting group title
    PF-07081532 40mg (T2DM)
    Reporting group description
    Subjects with T2DM inadequately controlled with metformin were administered PF-07081532 20 mg QD orally for 4 weeks followed by PF-07081532 40 mg QD orally.

    Reporting group title
    PF-07081532 80mg (T2DM)
    Reporting group description
    Subjects with T2DM inadequately controlled with metformin were administered titrating doses of PF-07081532 20 mg QD, 40 mg QD and 60 mg QD orally for 4 weeks each followed by PF-07081532 80 mg QD orally.

    Reporting group title
    PF-07081532 160mg (T2DM)
    Reporting group description
    Subjects with T2DM inadequately controlled with metformin were administered titrating doses of PF-07081532 20 mg QD 40 mg QD, 60 mg QD, 80 mg QD and 120 mg QD orally for 4 weeks each followed by PF-07081532 160 mg QD orally.

    Reporting group title
    PF-07081532 260mg (T2DM)
    Reporting group description
    Subjects with T2DM inadequately controlled with metformin were administered titrating doses of PF-07081532 20 mg QD, 40 mg QD, 80 mg QD, 140 mg QD and 200 mg QD orally for 4 weeks each followed by PF-07081532 260 mg QD orally.

    Reporting group title
    Rybelsus 14mg (T2DM)
    Reporting group description
    Subjects with T2DM inadequately controlled with metformin were administered titrating doses of Rybelsus 3 mg QD and 7 mg QD each for 4 weeks followed by 14 mg QD.

    Reporting group title
    Placebo (Obesity)
    Reporting group description
    Subjects randomized to receive a single dose of PF-07081532-matching placebo QD orally.

    Reporting group title
    PF-07081532 80mg (Obesity)
    Reporting group description
    Subjects with obesity were administered titrating doses of PF-07081532 20 mg QD, 40 mg QD and 60 mg QD orally for 4 weeks each followed by PF-07081532 80 mg QD orally.

    Reporting group title
    PF-07081532 140mg (Obesity)
    Reporting group description
    Subjects with obesity were administered titrating doses of PF-07081532 20 mg QD, 40 mg QD and 60 mg QD, 80 mg QD, 120 mg QD orally for 4 weeks each followed by PF-07081532 140 mg QD orally.

    Reporting group title
    PF-07081532 200mg (Obesity,5 steps)
    Reporting group description
    Subjects with obesity were administered titrating doses of PF-07081532 20 mg QD, 40 mg QD and 60 mg QD, 100 mg QD, 160 mg QD orally for 4 weeks each followed by PF-07081532 200 mg QD orally.

    Reporting group title
    PF-07081532 200mg (Obesity,4 steps)
    Reporting group description
    Subjects with obesity were administered titrating doses of PF-07081532 20 mg QD, 40 mg QD and 80 mg QD, 140 mg QD orally for 4 weeks each followed by PF-07081532 200 mg QD orally.

    Reporting group title
    PF-07081532 260mg (Obesity)
    Reporting group description
    Subjects with obesity were administered titrating doses of PF-07081532 20 mg QD, 40 mg QD and 80 mg QD, 140 mg QD, 200 mg QD orally for 4 weeks each followed by PF-07081532 260 mg QD orally.

    Reporting group values
    Placebo (T2DM) PF-07081532 20mg (T2DM) PF-07081532 40mg (T2DM) PF-07081532 80mg (T2DM) PF-07081532 160mg (T2DM) PF-07081532 260mg (T2DM) Rybelsus 14mg (T2DM) Placebo (Obesity) PF-07081532 80mg (Obesity) PF-07081532 140mg (Obesity) PF-07081532 200mg (Obesity,5 steps) PF-07081532 200mg (Obesity,4 steps) PF-07081532 260mg (Obesity) Total
    Number of subjects
    75 73 72 73 72 74 73 64 66 64 65 66 64 901
    Age Categorical
    Units: Subjects
        Less than (<) 18 years
    0 0 0 0 0 0 0 0 0 0 0 0 0 0
        18-44 years
    6 8 3 4 4 6 5 17 25 24 25 21 23 171
        45-64 years
    40 39 52 48 44 36 43 36 33 35 34 39 33 512
        More than equal to (>=) 65 years
    29 26 17 21 24 32 25 11 8 5 6 6 8 218
    Age continuous
    Units: years
        geometric mean (standard deviation)
    60.0 ( 10.17 ) 58.8 ( 10.17 ) 58.6 ( 8.47 ) 57.7 ( 9.21 ) 59.6 ( 9.71 ) 60.3 ( 9.76 ) 59.8 ( 8.89 ) 50.9 ( 13.30 ) 49.3 ( 12.97 ) 48.1 ( 12.44 ) 47.6 ( 13.49 ) 50.0 ( 10.74 ) 48.5 ( 11.68 ) -
    Sex: Female, Male
    Units: Subjects
        Female
    42 30 29 31 33 31 36 36 38 45 36 42 40 469
        Male
    33 43 43 42 39 43 37 28 28 19 29 24 24 432
    Race
    Units: Subjects
        American Indian or Alaska Native
    1 0 0 0 0 0 0 1 1 1 0 0 1 5
        Asian
    12 14 17 15 13 14 11 4 3 3 3 4 6 119
        Native Hawaiian or Other Pacific Islander
    0 0 0 0 0 0 0 0 0 1 0 0 0 1
        Black or African American
    4 2 4 4 5 5 5 4 6 15 6 5 4 69
        White
    58 57 51 54 54 54 57 55 56 44 56 55 52 703
        More than one race
    0 0 0 0 0 0 0 0 0 0 0 1 1 2
        Unknown or Not Reported
    0 0 0 0 0 1 0 0 0 0 0 1 0 2
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    14 13 8 7 14 10 8 5 8 10 14 12 10 133
        Not Hispanic or Latino
    61 60 63 66 58 64 64 59 58 54 51 54 54 766
        Unknown or Not Reported
    0 0 1 0 0 0 1 0 0 0 0 0 0 2

    End points

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    End points reporting groups
    Reporting group title
    Placebo (T2DM)
    Reporting group description
    Subjects randomized to receive a single dose of PF-07081532-matching placebo once daily (QD) orally.

    Reporting group title
    PF-07081532 20mg (T2DM)
    Reporting group description
    Subjects randomized to receive PF-07081532 20 mg QD orally.

    Reporting group title
    PF-07081532 40mg (T2DM)
    Reporting group description
    Subjects with T2DM inadequately controlled with metformin were administered PF-07081532 20 mg QD orally for 4 weeks followed by PF-07081532 40 mg QD orally.

    Reporting group title
    PF-07081532 80mg (T2DM)
    Reporting group description
    Subjects with T2DM inadequately controlled with metformin were administered titrating doses of PF-07081532 20 mg QD, 40 mg QD and 60 mg QD orally for 4 weeks each followed by PF-07081532 80 mg QD orally.

    Reporting group title
    PF-07081532 160mg (T2DM)
    Reporting group description
    Subjects with T2DM inadequately controlled with metformin were administered titrating doses of PF-07081532 20 mg QD 40 mg QD, 60 mg QD, 80 mg QD and 120 mg QD orally for 4 weeks each followed by PF-07081532 160 mg QD orally.

    Reporting group title
    PF-07081532 260mg (T2DM)
    Reporting group description
    Subjects with T2DM inadequately controlled with metformin were administered titrating doses of PF-07081532 20 mg QD, 40 mg QD, 80 mg QD, 140 mg QD and 200 mg QD orally for 4 weeks each followed by PF-07081532 260 mg QD orally.

    Reporting group title
    Rybelsus 14mg (T2DM)
    Reporting group description
    Subjects with T2DM inadequately controlled with metformin were administered titrating doses of Rybelsus 3 mg QD and 7 mg QD each for 4 weeks followed by 14 mg QD.

    Reporting group title
    Placebo (Obesity)
    Reporting group description
    Subjects randomized to receive a single dose of PF-07081532-matching placebo QD orally.

    Reporting group title
    PF-07081532 80mg (Obesity)
    Reporting group description
    Subjects with obesity were administered titrating doses of PF-07081532 20 mg QD, 40 mg QD and 60 mg QD orally for 4 weeks each followed by PF-07081532 80 mg QD orally.

    Reporting group title
    PF-07081532 140mg (Obesity)
    Reporting group description
    Subjects with obesity were administered titrating doses of PF-07081532 20 mg QD, 40 mg QD and 60 mg QD, 80 mg QD, 120 mg QD orally for 4 weeks each followed by PF-07081532 140 mg QD orally.

    Reporting group title
    PF-07081532 200mg (Obesity,5 steps)
    Reporting group description
    Subjects with obesity were administered titrating doses of PF-07081532 20 mg QD, 40 mg QD and 60 mg QD, 100 mg QD, 160 mg QD orally for 4 weeks each followed by PF-07081532 200 mg QD orally.

    Reporting group title
    PF-07081532 200mg (Obesity,4 steps)
    Reporting group description
    Subjects with obesity were administered titrating doses of PF-07081532 20 mg QD, 40 mg QD and 80 mg QD, 140 mg QD orally for 4 weeks each followed by PF-07081532 200 mg QD orally.

    Reporting group title
    PF-07081532 260mg (Obesity)
    Reporting group description
    Subjects with obesity were administered titrating doses of PF-07081532 20 mg QD, 40 mg QD and 80 mg QD, 140 mg QD, 200 mg QD orally for 4 weeks each followed by PF-07081532 260 mg QD orally.
    Reporting group title
    Placebo (T2DM)
    Reporting group description
    Subjects randomized to receive a single dose of PF-07081532-matching placebo once daily (QD) orally.

    Reporting group title
    PF-07081532 20mg (T2DM)
    Reporting group description
    Subjects randomized to receive PF-07081532 20 mg QD orally.

    Reporting group title
    PF-07081532 40mg (T2DM)
    Reporting group description
    Subjects randomized to receive PF-07081532 20 mg QD orally for 4 weeks, followed by 40 mg QD orally.

    Reporting group title
    PF-07081532 80mg (T2DM)
    Reporting group description
    Subjects randomized to receive PF-07081532 20 mg QD, 40 mg QD and 60 mg QD orally for 4 weeks, followed by PF-07081532 80 mg QD orally.

    Reporting group title
    PF-07081532 160mg (T2DM)
    Reporting group description
    Subjects randomized to receive PF-07081532 20 mg QD 40 mg QD, 60 mg QD, 80 mg QD and 120 mg QD orally for 4 weeks, followed by PF-07081532 160 mg QD orally.

    Reporting group title
    PF-07081532 260mg (T2DM)
    Reporting group description
    Subjects randomized to receive PF-07081532 20 mg QD, 40 mg QD, 80 mg QD, 140 mg QD and 200 mg QD orally for 4 weeks, followed by PF-07081532 260 mg QD orally.

    Reporting group title
    Rybelsus 14mg (T2DM)
    Reporting group description
    Subjects randomized to receive Rybelsus 3 mg QD and 7 mg QD each for 4 weeks followed by 14 mg QD.

    Reporting group title
    Placebo (Obesity)
    Reporting group description
    Subjects randomized to receive a single dose of PF-07081532-matching placebo QD orally.

    Reporting group title
    PF-07081532 80mg (Obesity)
    Reporting group description
    Subjects randomized to receive PF-07081532 20 mg QD, 40 mg QD and 60 mg QD orally for 4 weeks, followed by PF-07081532 80 mg QD orally.

    Reporting group title
    PF-07081532 140mg (Obesity)
    Reporting group description
    Subjects randomized to receive PF-07081532 20 mg QD, 40 mg QD and 60 mg QD, 80 mg QD,120 mg QD orally for 4 weeks each followed by PF-07081532 140 mg QD orally.

    Reporting group title
    PF-07081532 200mg (Obesity,5 steps)
    Reporting group description
    Subjects randomized to receive PF-07081532 20 mg QD, 40 mg QD and 60 mg QD, 100 mg QD,160 mg QD orally for 4 weeks each followed by PF-07081532 200 mg QD orally.

    Reporting group title
    PF-07081532 200mg (Obesity,4 steps)
    Reporting group description
    Subjects randomized to receive PF-07081532 20 mg QD, 40 mg QD and 80 mg QD, 140 mg QD orally for 4 weeks each followed by PF-07081532 200 mg QD orally.

    Reporting group title
    PF-07081532 260mg (Obesity)
    Reporting group description
    Subjects randomized to receive PF-07081532 20 mg QD, 40 mg QD and 80 mg QD, 140 mg QD, 200 mg QD orally for 4 weeks each followed by PF-07081532 260 mg QD orally.

    Subject analysis set title
    Placebo (T2DM
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Subjects with T2DM inadequately controlled with metformin were administered PF-07081532-matching placebo once daily (QD) orally.

    Subject analysis set title
    PF-07081532 40 mg (T2DM)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Subjects randomized to receive PF-07081532 40 mg QD orally were included.

    Subject analysis set title
    PF-07081532 60mg (T2DM)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Subjects randomized to receive PF-07081532 60 mg QD orally were included.

    Subject analysis set title
    PF-07081532 80 mg (T2DM)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    randomized to receive PF-07081532 80 mg QD orally were included.

    Subject analysis set title
    PF-07081532 120 mg (T2DM)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Subjects randomized to receive PF-07081532 120 mg QD orally were included.

    Subject analysis set title
    PF-07081532 140mg (T2DM)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Subjects randomized to receive PF-07081532 140 mg QD orally were included.

    Subject analysis set title
    PF-07081532 200mg (T2DM)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Subjects randomized to receive PF-07081532 200 mg QD orally were included.

    Subject analysis set title
    PF-07081532 260 mg (T2DM)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Subjects randomized to receive PF-07081532 260 mg QD orally were included.

    Subject analysis set title
    Rybelsus 3mg (T2DM)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Subjects randomized to receive Rybelsus 3 mg QD orally were included.

    Subject analysis set title
    Rybelsus 7mg (T2DM)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Subjects randomized to receive Rybelsus 7 mg QD orally were included.

    Subject analysis set title
    PF-07081532 20mg (Obesity)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Subjects randomized to receive PF-07081532 20 mg QD orally were included.

    Subject analysis set title
    PF-07081532 40 mg (Obesity)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Subjects randomized to receive PF-07081532 40 mg QD orally were included.

    Subject analysis set title
    PF-07081532 60 mg (Obesity)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Subjects randomized to receive PF-07081532 60 mg QD orally were included.

    Subject analysis set title
    PF-07081532 100 mg (Obesity)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Subjects randomized to receive PF-07081532 100 mg QD orally were included.

    Subject analysis set title
    PF-07081532 120 mg (Obesity)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Subjects randomized to receive PF-07081532 120 mg QD orally were included.

    Subject analysis set title
    PF-07081532 160 mg (Obesity)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Subjects randomized to receive PF-07081532 160 mg QD orally were included.

    Subject analysis set title
    PF-07081532 200 mg (Obesity)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Subjects randomized to receive PF-07081532 200 mg QD orally were included.

    Subject analysis set title
    PF-07081532 260 mg (Obesity)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Subjects randomized to receive PF-07081532 260 mg QD orally were included.

    Subject analysis set title
    PF-07081532 160 mg (T2DM)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Subjects randomized to receive PF-07081532 160 mg QD orally were included.

    Subject analysis set title
    Rybelsus 14 mg (T2DM)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Subjects randomized to receive Rybelsus 14 mg QD orally were included.

    Subject analysis set title
    PF-07081532 80 mg (Obesity)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Subjects randomized to receive PF-07081532 80 mg QD orally were included.

    Subject analysis set title
    PF-07081532 140 mg (Obesity)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Subjects randomized to receive PF-07081532 140 mg QD orally were included.

    Subject analysis set title
    PF-07081532 20mg (T2DM)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Subjects randomized to receive PF-07081532 20 mg QD orally were included.

    Primary: Placebo-adjusted, Change From Baseline in Percentage of Glycated Hemoglobin (HbA1c) at Week 32: Cohort 1 (Type 2 Diabetes Mellitus)

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    End point title
    Placebo-adjusted, Change From Baseline in Percentage of Glycated Hemoglobin (HbA1c) at Week 32: Cohort 1 (Type 2 Diabetes Mellitus) [1] [2]
    End point description
    Data was not collected for this endpoint as the study was terminated prior to any subject reaching Week 32.
    End point type
    Primary
    End point timeframe
    Baseline (result closest prior to dosing on Day 1), Week 32
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical Analysis was not planned for this endpoint
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical Analysis was not planned for this endpoint
    End point values
    Placebo (T2DM) PF-07081532 20mg (T2DM) PF-07081532 40mg (T2DM) PF-07081532 80mg (T2DM) PF-07081532 160mg (T2DM) PF-07081532 260mg (T2DM) Rybelsus 14mg (T2DM)
    Number of subjects analysed
    0 [3]
    0 [4]
    0 [5]
    0 [6]
    0 [7]
    0 [8]
    0 [9]
    Units: Percentage of HbA1c
        least squares mean (standard error)
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    Notes
    [3] - Data was not collected for this endpoint as the study was terminated prior to Week 32.
    [4] - Data was not collected for this endpoint as the study was terminated prior to Week 32.
    [5] - Data was not collected for this endpoint as the study was terminated prior to Week 32.
    [6] - Data was not collected for this endpoint as the study was terminated prior to Week 32.
    [7] - Data was not collected for this endpoint as the study was terminated prior to Week 32.
    [8] - Data was not collected for this endpoint as the study was terminated prior to Week 32.
    [9] - Data was not collected for this endpoint as the study was terminated prior to Week 32.
    No statistical analyses for this end point

    Primary: Placebo-adjusted, Percent Change From Baseline in Body Weight at Week 32: Cohort 2 (Obesity)

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    End point title
    Placebo-adjusted, Percent Change From Baseline in Body Weight at Week 32: Cohort 2 (Obesity) [10] [11]
    End point description
    Body weight was measured using a calibrated weighing scale. Data was not collected for this endpoint as the study was terminated prior to any subject reaching Week 32.
    End point type
    Primary
    End point timeframe
    Baseline (result closest prior to dosing on Day 1), Week 32
    Notes
    [10] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical Analysis was not planned for this endpoint
    [11] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical Analysis was not planned for this endpoint
    End point values
    Placebo (Obesity) PF-07081532 80mg (Obesity) PF-07081532 140mg (Obesity) PF-07081532 200mg (Obesity,5 steps) PF-07081532 200mg (Obesity,4 steps) PF-07081532 260mg (Obesity)
    Number of subjects analysed
    0 [12]
    0 [13]
    0 [14]
    0 [15]
    0 [16]
    0 [17]
    Units: Percent change
        least squares mean (standard error)
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    Notes
    [12] - Data was not collected for this endpoint as the study was terminated prior to Week 32.
    [13] - Data was not collected for this endpoint as the study was terminated prior to Week 32.
    [14] - Data was not collected for this endpoint as the study was terminated prior to Week 32.
    [15] - Data was not collected for this endpoint as the study was terminated prior to Week 32.
    [16] - Data was not collected for this endpoint as the study was terminated prior to Week 32.
    [17] - Data was not collected for this endpoint as the study was terminated prior to Week 32.
    No statistical analyses for this end point

    Secondary: Percentage of Subjects who Achieved HbA1C <7% at Week 32: Cohort 1 (Type 2 Diabetes Mellitus)

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    End point title
    Percentage of Subjects who Achieved HbA1C <7% at Week 32: Cohort 1 (Type 2 Diabetes Mellitus) [18]
    End point description
    Data was not collected for this endpoint as the study was terminated prior to any subject reaching Week 32.
    End point type
    Secondary
    End point timeframe
    Baseline (result closest prior to dosing on Day 1), Week 32
    Notes
    [18] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical Analysis was not planned for this endpoint
    End point values
    Placebo (T2DM) PF-07081532 20mg (T2DM) PF-07081532 40mg (T2DM) PF-07081532 80mg (T2DM) PF-07081532 160mg (T2DM) PF-07081532 260mg (T2DM) Rybelsus 14mg (T2DM)
    Number of subjects analysed
    0 [19]
    0 [20]
    0 [21]
    0 [22]
    0 [23]
    0 [24]
    0 [25]
    Units: Percentage of subjects
        number (not applicable)
    Notes
    [19] - Data was not collected for this endpoint as the study was terminated prior to Week 32.
    [20] - Data was not collected for this endpoint as the study was terminated prior to Week 32.
    [21] - Data was not collected for this endpoint as the study was terminated prior to Week 32.
    [22] - Data was not collected for this endpoint as the study was terminated prior to Week 32.
    [23] - Data was not collected for this endpoint as the study was terminated prior to Week 32.
    [24] - Data was not collected for this endpoint as the study was terminated prior to Week 32.
    [25] - Data was not collected for this endpoint as the study was terminated prior to Week 32.
    No statistical analyses for this end point

    Secondary: Change From Baseline in Fasting Plasma Glucose (FPG) at Week 32: Cohort 1 (Type 2 Diabetes Mellitus)

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    End point title
    Change From Baseline in Fasting Plasma Glucose (FPG) at Week 32: Cohort 1 (Type 2 Diabetes Mellitus) [26]
    End point description
    Data was not collected for this endpoint as the study was terminated prior to any subject reaching Week 32.
    End point type
    Secondary
    End point timeframe
    Baseline (result closest prior to dosing on Day 1), Week 32
    Notes
    [26] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical Analysis was not planned for this endpoint
    End point values
    Placebo (T2DM) PF-07081532 20mg (T2DM) PF-07081532 40mg (T2DM) PF-07081532 80mg (T2DM) PF-07081532 160mg (T2DM) PF-07081532 260mg (T2DM) Rybelsus 14mg (T2DM)
    Number of subjects analysed
    0 [27]
    0 [28]
    0 [29]
    0 [30]
    0 [31]
    0 [32]
    0 [33]
    Units: milligrams per deciliter (mg/dL)
        arithmetic mean (standard deviation)
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    Notes
    [27] - Data was not collected for this endpoint as the study was terminated prior to Week 32.
    [28] - Data was not collected for this endpoint as the study was terminated prior to Week 32.
    [29] - Data was not collected for this endpoint as the study was terminated prior to Week 32.
    [30] - Data was not collected for this endpoint as the study was terminated prior to Week 32.
    [31] - Data was not collected for this endpoint as the study was terminated prior to Week 32.
    [32] - Data was not collected for this endpoint as the study was terminated prior to Week 32.
    [33] - Data was not collected for this endpoint as the study was terminated prior to Week 32.
    No statistical analyses for this end point

    Secondary: Percent Change From Baseline in Body Weight at Week 32: Cohort 1 (Type 2 Diabetes Mellitus)

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    End point title
    Percent Change From Baseline in Body Weight at Week 32: Cohort 1 (Type 2 Diabetes Mellitus) [34]
    End point description
    Body weight was measured using a calibrated weighing scale. Data was not collected for Week 32 as the study was terminated prior to any subject reaching Week 32.
    End point type
    Secondary
    End point timeframe
    Baseline (result closest prior to dosing on Day 1), Week 32
    Notes
    [34] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical Analysis was not planned for this endpoint
    End point values
    Placebo (T2DM) PF-07081532 20mg (T2DM) PF-07081532 40mg (T2DM) PF-07081532 80mg (T2DM) PF-07081532 160mg (T2DM) PF-07081532 260mg (T2DM) Rybelsus 14mg (T2DM)
    Number of subjects analysed
    0 [35]
    0 [36]
    0 [37]
    0 [38]
    0 [39]
    0 [40]
    0 [41]
    Units: Percent change
        arithmetic mean (standard deviation)
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    Notes
    [35] - Data was not collected for this endpoint as the study was terminated prior to Week 32.
    [36] - Data was not collected for this endpoint as the study was terminated prior to Week 32.
    [37] - Data was not collected for this endpoint as the study was terminated prior to Week 32.
    [38] - Data was not collected for this endpoint as the study was terminated prior to Week 32.
    [39] - Data was not collected for this endpoint as the study was terminated prior to Week 32.
    [40] - Data was not collected for this endpoint as the study was terminated prior to Week 32.
    [41] - Data was not collected for this endpoint as the study was terminated prior to Week 32.
    No statistical analyses for this end point

    Secondary: Placebo-adjusted, Change From Baseline in HbA1C in the Rybelsus arm at Week 32: Cohort 1 (Type 2 Diabetes Mellitus)

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    End point title
    Placebo-adjusted, Change From Baseline in HbA1C in the Rybelsus arm at Week 32: Cohort 1 (Type 2 Diabetes Mellitus) [42]
    End point description
    Data was not collected for this endpoint as the study was terminated prior to any subject reaching Week 32. This endpoint was planned to be analyzed only for rybelsus arm and placebo arm as pre-specified in the protocol.
    End point type
    Secondary
    End point timeframe
    Baseline (result closest prior to dosing on Day 1), Week 32
    Notes
    [42] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical Analysis was not planned for this endpoint
    End point values
    Placebo (T2DM) Rybelsus 14mg (T2DM)
    Number of subjects analysed
    0 [43]
    0 [44]
    Units: Percentage of HbA1c
        arithmetic mean (standard deviation)
    ( )
    ( )
    Notes
    [43] - Data was not collected for this endpoint as the study was terminated prior to Week 32.
    [44] - Data was not collected for this endpoint as the study was terminated prior to Week 32.
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Achieving >=5%, >=10%, and >=15% Body Weight Loss at Week 32 Relative to Baseline: Cohort 2 (Obesity)

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    End point title
    Percentage of Subjects Achieving >=5%, >=10%, and >=15% Body Weight Loss at Week 32 Relative to Baseline: Cohort 2 (Obesity) [45]
    End point description
    Data was not collected for this endpoint as the study was terminated prior to any subject reaching Week 32.
    End point type
    Secondary
    End point timeframe
    Baseline (result closest prior to dosing on Day 1), Week 32
    Notes
    [45] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical Analysis was not planned for this endpoint
    End point values
    Placebo (Obesity) PF-07081532 80mg (Obesity) PF-07081532 140mg (Obesity) PF-07081532 200mg (Obesity,5 steps) PF-07081532 200mg (Obesity,4 steps) PF-07081532 260mg (Obesity)
    Number of subjects analysed
    0 [46]
    0 [47]
    0 [48]
    0 [49]
    0 [50]
    0 [51]
    Units: Percentage of subjects
        number (not applicable)
    Notes
    [46] - Data was not collected for this endpoint as the study was terminated prior to Week 32.
    [47] - Data was not collected for this endpoint as the study was terminated prior to Week 32.
    [48] - Data was not collected for this endpoint as the study was terminated prior to Week 32.
    [49] - Data was not collected for this endpoint as the study was terminated prior to Week 32.
    [50] - Data was not collected for this endpoint as the study was terminated prior to Week 32.
    [51] - Data was not collected for this endpoint as the study was terminated prior to Week 32.
    No statistical analyses for this end point

    Secondary: Absolute Change From Baseline in Waist Circumference at Week 32: Cohort 2 (Obesity)

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    End point title
    Absolute Change From Baseline in Waist Circumference at Week 32: Cohort 2 (Obesity) [52]
    End point description
    Waist circumference was measured at midpoint, between lower margin of last palpable rib and top of iliac crest (approximately 1 inch [2.54 centimeter {cm}] above the navel). It was measured by using an anthropometric tape (stretch-resistant). Data was not collected for this endpoint as the study was terminated prior to any subject reaching Week 32.
    End point type
    Secondary
    End point timeframe
    Baseline (result closest prior to dosing on Day 1), Week 32
    Notes
    [52] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical Analysis was not planned for this endpoint
    End point values
    Placebo (Obesity) PF-07081532 80mg (Obesity) PF-07081532 140mg (Obesity) PF-07081532 200mg (Obesity,5 steps) PF-07081532 200mg (Obesity,4 steps) PF-07081532 260mg (Obesity)
    Number of subjects analysed
    0 [53]
    0 [54]
    0 [55]
    0 [56]
    0 [57]
    0 [58]
    Units: Centimeter
        arithmetic mean (standard deviation)
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    Notes
    [53] - Data was not collected for this endpoint as the study was terminated prior to Week 32.
    [54] - Data was not collected for this endpoint as the study was terminated prior to Week 32.
    [55] - Data was not collected for this endpoint as the study was terminated prior to Week 32.
    [56] - Data was not collected for this endpoint as the study was terminated prior to Week 32.
    [57] - Data was not collected for this endpoint as the study was terminated prior to Week 32.
    [58] - Data was not collected for this endpoint as the study was terminated prior to Week 32.
    No statistical analyses for this end point

    Secondary: Absolute Change From Baseline in Waist-to-hip Ratio at Week 32: Cohort 2 (Obesity)

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    End point title
    Absolute Change From Baseline in Waist-to-hip Ratio at Week 32: Cohort 2 (Obesity) [59]
    End point description
    The hip circumference was defined as the circumference around the widest portion of the buttocks. Waist circumference was measured at midpoint, between lower margin of last palpable rib and top of iliac crest (approximately 1 inch [2.54 cm] above the navel). The measurements were performed using an anthropometric tape (stretch-resistant). Data was not collected for this endpoint as the study was terminated prior to any subject reaching Week 32.
    End point type
    Secondary
    End point timeframe
    Baseline (result closest prior to dosing on Day 1), Week 32
    Notes
    [59] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical Analysis was not planned for this endpoint
    End point values
    Placebo (Obesity) PF-07081532 140mg (Obesity) PF-07081532 200mg (Obesity,5 steps) PF-07081532 200mg (Obesity,4 steps) PF-07081532 260mg (Obesity)
    Number of subjects analysed
    0 [60]
    0 [61]
    0 [62]
    0 [63]
    0 [64]
    Units: Ratio
        arithmetic mean (standard deviation)
    ( )
    ( )
    ( )
    ( )
    ( )
    Notes
    [60] - Data was not collected for this endpoint as the study was terminated prior to Week 32.
    [61] - Data was not collected for this endpoint as the study was terminated prior to Week 32.
    [62] - Data was not collected for this endpoint as the study was terminated prior to Week 32.
    [63] - Data was not collected for this endpoint as the study was terminated prior to Week 32.
    [64] - Data was not collected for this endpoint as the study was terminated prior to Week 32.
    No statistical analyses for this end point

    Secondary: Change From Baseline in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) at Week 32: Cohort 2 (Obesity)

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    End point title
    Change From Baseline in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) at Week 32: Cohort 2 (Obesity) [65]
    End point description
    HOMA-IR was calculated as: fasting plasma insulin ([FPI]*(FPG)/405 and measured in terms of mg/dL* (milliunits per liter). Data was not collected for this endpoint as the study was terminated prior to any subject reaching Week 32.
    End point type
    Secondary
    End point timeframe
    Baseline (result closest prior to dosing on Day 1), Week 32
    Notes
    [65] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical Analysis was not planned for this endpoint
    End point values
    Placebo (Obesity) PF-07081532 80mg (Obesity) PF-07081532 140mg (Obesity) PF-07081532 200mg (Obesity,5 steps) PF-07081532 200mg (Obesity,4 steps) PF-07081532 260mg (Obesity)
    Number of subjects analysed
    0 [66]
    0 [67]
    0 [68]
    0 [69]
    0 [70]
    0 [71]
    Units: Mg/dL* (milliunits per liter)
        arithmetic mean (standard deviation)
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    Notes
    [66] - Data was not collected for this endpoint as the study was terminated prior to Week 32.
    [67] - Data was not collected for this endpoint as the study was terminated prior to Week 32.
    [68] - Data was not collected for this endpoint as the study was terminated prior to Week 32.
    [69] - Data was not collected for this endpoint as the study was terminated prior to Week 32.
    [70] - Data was not collected for this endpoint as the study was terminated prior to Week 32.
    [71] - Data was not collected for this endpoint as the study was terminated prior to Week 32.
    No statistical analyses for this end point

    Secondary: Change From Baseline in Homeostatic Model Assessment for Insulin Sensitivity (HOMA-S) at Week 32: Cohort 2 (Obesity)

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    End point title
    Change From Baseline in Homeostatic Model Assessment for Insulin Sensitivity (HOMA-S) at Week 32: Cohort 2 (Obesity) [72]
    End point description
    HOMA-S was calculated as (22.5/[FPI] * FPG) *100 and measured in terms of percentage sensitivity. Data was not collected for this endpoint as the study was terminated prior to any subject reaching Week 32.
    End point type
    Secondary
    End point timeframe
    Baseline (result closest prior to dosing on Day 1), Week 32
    Notes
    [72] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical Analysis was not planned for this endpoint
    End point values
    Placebo (Obesity) PF-07081532 80mg (Obesity) PF-07081532 140mg (Obesity) PF-07081532 200mg (Obesity,5 steps) PF-07081532 200mg (Obesity,4 steps) PF-07081532 260mg (Obesity)
    Number of subjects analysed
    0 [73]
    0 [74]
    0 [75]
    0 [76]
    0 [77]
    0 [78]
    Units: Percentage sensitivity
        arithmetic mean (standard deviation)
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    Notes
    [73] - Data was not collected for this endpoint as the study was terminated prior to Week 32.
    [74] - Data was not collected for this endpoint as the study was terminated prior to Week 32.
    [75] - Data was not collected for this endpoint as the study was terminated prior to Week 32.
    [76] - Data was not collected for this endpoint as the study was terminated prior to Week 32.
    [77] - Data was not collected for this endpoint as the study was terminated prior to Week 32.
    [78] - Data was not collected for this endpoint as the study was terminated prior to Week 32.
    No statistical analyses for this end point

    Secondary: Number of Subjects With Treatment Emergent Adverse Events (TEAEs): Cohort 1 (Type 2 Diabetes Mellitus)

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    End point title
    Number of Subjects With Treatment Emergent Adverse Events (TEAEs): Cohort 1 (Type 2 Diabetes Mellitus) [79]
    End point description
    An adverse event (AE) was any untoward medical occurrence in a subject or clinical study subject, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were any AEs that occurred on or after the first dose of treatment but before the last dose plus lag time. Safety analysis set included all subjects randomly assigned to study intervention and who took at least 1 dose of study intervention. Subjects were analyzed according to the product they actually received.
    End point type
    Secondary
    End point timeframe
    From start of treatment up to minimum of 28 days after last dose of treatment administration (maximum up to Week 28)
    Notes
    [79] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical Analysis was not planned for this endpoint
    End point values
    Placebo (T2DM) PF-07081532 20mg (T2DM) PF-07081532 40mg (T2DM) PF-07081532 80mg (T2DM) PF-07081532 160mg (T2DM) PF-07081532 260mg (T2DM) Rybelsus 14mg (T2DM)
    Number of subjects analysed
    75
    73
    72
    73
    72
    74
    73
    Units: Subjects
    35
    37
    50
    44
    45
    56
    36
    No statistical analyses for this end point

    Secondary: Number of Subjects With Treatment Emergent Adverse Events (TEAEs): Cohort 2 (Obesity)

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    End point title
    Number of Subjects With Treatment Emergent Adverse Events (TEAEs): Cohort 2 (Obesity) [80]
    End point description
    An AE was any untoward medical occurrence in a subject or clinical study subject, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were any AEs that occurred on or after the first dose of treatment but before the last dose plus lag time. Safety analysis set included all subjects randomly assigned to study intervention and who took at least 1 dose of study intervention. Subjects were analyzed according to the product they actually received.
    End point type
    Secondary
    End point timeframe
    From start of treatment up to minimum of 28 days after last dose of treatment administration (maximum up to Week 28)
    Notes
    [80] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical Analysis was not planned for this endpoint
    End point values
    Placebo (Obesity) PF-07081532 80mg (Obesity) PF-07081532 140mg (Obesity) PF-07081532 200mg (Obesity,5 steps) PF-07081532 200mg (Obesity,4 steps) PF-07081532 260mg (Obesity)
    Number of subjects analysed
    64
    66
    64
    65
    66
    64
    Units: Subjects
    44
    54
    50
    56
    60
    53
    No statistical analyses for this end point

    Secondary: Number of Subjects With Serious Adverse Events (SAEs): Cohort 1 (Type 2 Diabetes Mellitus)

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    End point title
    Number of Subjects With Serious Adverse Events (SAEs): Cohort 1 (Type 2 Diabetes Mellitus) [81]
    End point description
    An SAE defined was any untoward medical occurrence that, at any dose, met one or more of the following criteria: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect; was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic; other important medical events. Safety analysis set included all subjects randomly assigned to study intervention and who took at least 1 dose of study intervention. Subjects were analyzed according to the product they actually received.
    End point type
    Secondary
    End point timeframe
    From start of treatment up to minimum of 28 days after last dose of treatment administration (maximum up to Week 28)
    Notes
    [81] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical Analysis was not planned for this endpoint
    End point values
    Placebo (T2DM) PF-07081532 20mg (T2DM) PF-07081532 40mg (T2DM) PF-07081532 80mg (T2DM) PF-07081532 160mg (T2DM) PF-07081532 260mg (T2DM) Rybelsus 14mg (T2DM)
    Number of subjects analysed
    75
    73
    72
    73
    72
    74
    73
    Units: Subjects
    1
    0
    3
    3
    1
    2
    1
    No statistical analyses for this end point

    Secondary: Number of Subjects With Serious Adverse Events (SAEs): Cohort 2 (Obesity)

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    End point title
    Number of Subjects With Serious Adverse Events (SAEs): Cohort 2 (Obesity) [82]
    End point description
    An SAE defined was any untoward medical occurrence that, at any dose, met one or more of the following criteria: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect; was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic; other important medical events. Safety analysis set included all subjects randomly assigned to study intervention and who took at least 1 dose of study intervention. Subjects were analyzed according to the product they actually received.
    End point type
    Secondary
    End point timeframe
    From start of treatment up to minimum of 28 days after last dose of treatment administration (maximum up to Week 28)
    Notes
    [82] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical Analysis was not planned for this endpoint
    End point values
    Placebo (Obesity) PF-07081532 80mg (Obesity) PF-07081532 140mg (Obesity) PF-07081532 200mg (Obesity,5 steps) PF-07081532 200mg (Obesity,4 steps) PF-07081532 260mg (Obesity)
    Number of subjects analysed
    64
    66
    64
    65
    66
    64
    Units: Subjects
    1
    2
    2
    1
    2
    2
    No statistical analyses for this end point

    Secondary: Number of Subjects Reporting Adverse Events Leading to Permanent Discontinuation From Study Treatment and Study: Cohort 1 (Type 2 Diabetes Mellitus)

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    End point title
    Number of Subjects Reporting Adverse Events Leading to Permanent Discontinuation From Study Treatment and Study: Cohort 1 (Type 2 Diabetes Mellitus) [83]
    End point description
    An AE was any untoward medical occurrence in a subject or clinical study subject, temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs leading to permanent discontinuation from study were those with an AE record indicating the AE caused permanent discontinuation from the study. AEs leading to permanent discontinuation from study treatment were those AEs with an AE record indicating that action taken with study treatment was drug withdrawn but AE did not cause the subject to be discontinued from study. Safety Analysis set included all subjects randomly assigned to study intervention and who took at least 1 dose of study intervention.
    End point type
    Secondary
    End point timeframe
    From start of treatment up to minimum of 28 days after last dose of treatment administration (maximum up to Week 28)
    Notes
    [83] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical Analysis was not planned for this endpoint
    End point values
    Placebo (T2DM) PF-07081532 20mg (T2DM) PF-07081532 40mg (T2DM) PF-07081532 80mg (T2DM) PF-07081532 160mg (T2DM) PF-07081532 260mg (T2DM) Rybelsus 14mg (T2DM)
    Number of subjects analysed
    75
    73
    72
    73
    72
    74
    73
    Units: Subjects
        Discontinuations from study due to TEAEs
    1
    0
    0
    0
    0
    0
    0
        Discontinuations from intervention due to TEAEs
    0
    3
    11
    10
    5
    17
    5
    No statistical analyses for this end point

    Secondary: Number of Subjects Reporting Adverse Events Leading to Permanent Discontinuation From Study Treatment and Study: Cohort 2 (Obesity)

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    End point title
    Number of Subjects Reporting Adverse Events Leading to Permanent Discontinuation From Study Treatment and Study: Cohort 2 (Obesity) [84]
    End point description
    An AE was any untoward medical occurrence in a subject or clinical study subject, temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs leading to permanent discontinuation from study were those with an AE record indicating the AE caused permanent discontinuation from the study. AEs leading to permanent discontinuation from study treatment were those AEs with an AE record indicating that action taken with study treatment was drug withdrawn but AE did not cause the subject to be discontinued from study. Safety Analysis set included all subjects randomly assigned to study intervention and who took at least 1 dose of study intervention.
    End point type
    Secondary
    End point timeframe
    From start of treatment up to minimum of 28 days after last dose of treatment administration (maximum up to Week 28)
    Notes
    [84] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical Analysis was not planned for this endpoint
    End point values
    Placebo (Obesity) PF-07081532 80mg (Obesity) PF-07081532 140mg (Obesity) PF-07081532 200mg (Obesity,5 steps) PF-07081532 200mg (Obesity,4 steps) PF-07081532 260mg (Obesity)
    Number of subjects analysed
    64
    66
    64
    65
    66
    64
    Units: Subjects
        Discontinuations from study due to TEAEs
    0
    0
    1
    0
    0
    1
        Discontinuations from intervention due to TEAEs
    5
    12
    19
    15
    24
    22
    No statistical analyses for this end point

    Secondary: Number of Subjects With Hypoglycemic Adverse Events (HAE) According to Titration Dose: Cohort 1 (Type 2 Diabetes Mellitus)

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    End point title
    Number of Subjects With Hypoglycemic Adverse Events (HAE) According to Titration Dose: Cohort 1 (Type 2 Diabetes Mellitus) [85]
    End point description
    Glucose values monitored by glucometer. Hypoglycemia =plasma/blood glucose value of <70 mg/dL (3.9 millimoles per liter [mmol/L]). Severe HAE: Subject unable to self treat due to neurological impairment (not age) and required assistance, at least one neurological symptom of memory loss, confusion, etc. Documented blood glucose<=54 mg/dL (2.7 mmol/L). Documented symptomatic: event during which symptoms of HAE were accompanied with plasma/blood glucose <70 mg/dL and prompt resolution with food intake, SC glucagon, or IV glucose. Probable symptomatic: event during which symptoms of HAE were not accompanied by a plasma glucose determination but was presumably caused by a plasma glucose <70 mg/dL. Asymptomatic: An event not accompanied by typical symptoms of HAE, plasma/blood glucose value of <70 mg/dL. Safety Analysis set used. Here, N= total number of subjects with at least one dose of the given titration dose level after pooling of data across each titration dose.
    End point type
    Secondary
    End point timeframe
    Up to week 28
    Notes
    [85] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical Analysis was not planned for this endpoint
    End point values
    PF-07081532 160mg (T2DM) Rybelsus 14mg (T2DM) Placebo (T2DM PF-07081532 40 mg (T2DM) PF-07081532 60mg (T2DM) PF-07081532 80 mg (T2DM) PF-07081532 120 mg (T2DM) PF-07081532 140mg (T2DM) PF-07081532 200mg (T2DM) PF-07081532 260 mg (T2DM) Rybelsus 3mg (T2DM) Rybelsus 7mg (T2DM) PF-07081532 20mg (T2DM)
    Number of subjects analysed
    7
    70
    75
    281
    136
    193
    25
    58
    20
    6
    73
    72
    364
    Units: Subjects
        Severe Hypoglycemia
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
        Documented Symptomatic Hypoglycemia
    0
    1
    0
    2
    1
    0
    0
    0
    0
    0
    2
    2
    0
        Asymptomatic Hypoglycemia
    1
    2
    1
    1
    1
    1
    1
    1
    0
    0
    0
    1
    0
        Probable Symptomatic Hypoglycemia
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    No statistical analyses for this end point

    Secondary: Number of Subjects With Hypoglycemic Adverse Events According to Titration Dose: Cohort 2 (Obesity)

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    End point title
    Number of Subjects With Hypoglycemic Adverse Events According to Titration Dose: Cohort 2 (Obesity) [86]
    End point description
    Glucose values monitored by glucometer. Hypoglycemia =plasma/blood glucose value of <70 mg/dL (3.9 millimoles per liter [mmol/L]). Severe HAE: Subject unable to self treat due to neurological impairment (not age) and required assistance, at least one neurological symptom of memory loss, confusion, etc. Documented blood glucose<=54 mg/dL (2.7 mmol/L). Documented symptomatic: event during which symptoms of HAE were accompanied with plasma/blood glucose <70 mg/dL and prompt resolution with food intake, SC glucagon, or IV glucose. Probable symptomatic: event during which symptoms of HAE were not accompanied by a plasma glucose determination but was presumably caused by a plasma glucose <70 mg/dL. Asymptomatic: An event not accompanied by typical symptoms of HAE, plasma/blood glucose value of <70 mg/dL. Safety Analysis set used. Here, N= total number of subjects with at least one dose of the given titration dose level after pooling of data across each titration dose.
    End point type
    Secondary
    End point timeframe
    Up to week 28
    Notes
    [86] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical Analysis was not planned for this endpoint
    End point values
    Placebo (Obesity) PF-07081532 20mg (Obesity) PF-07081532 40 mg (Obesity) PF-07081532 60 mg (Obesity) PF-07081532 100 mg (Obesity) PF-07081532 120 mg (Obesity) PF-07081532 160 mg (Obesity) PF-07081532 200 mg (Obesity) PF-07081532 260 mg (Obesity) PF-07081532 80 mg (Obesity) PF-07081532 140 mg (Obesity)
    Number of subjects analysed
    64
    325
    310
    170
    56
    43
    47
    121
    28
    220
    140
    Units: Subjects
        Severe Hypoglycemia
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Documented Symptomatic Hypoglycemia
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Asymptomatic Hypoglycemia
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Probable Symptomatic Hypoglycemia
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects With Vital Sign Abnormalities: Cohort 1 (Type 2 Diabetes Mellitus)

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    End point title
    Number of Subjects With Vital Sign Abnormalities: Cohort 1 (Type 2 Diabetes Mellitus) [87]
    End point description
    Vital signs included blood pressure and pulse rate and were measured with the subjects in a seated position after at least 5 minutes of rest for the subject. Criteria for abnormalities included: Systolic Blood Pressure (millimeter of mercury [mmHg]): value more than (>) 200 and value less than (<) 90; Diastolic blood pressure: value > 100 and < 40; Pulse rate: (beats per minute [BPM]): value < 40 and > 110. Safety analysis set (SAS) included all subjects randomly assigned to study intervention and who took at least 1 dose of study intervention. Subjects were analyzed according to the product they actually received.
    End point type
    Secondary
    End point timeframe
    Up to Week 28
    Notes
    [87] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical Analysis was not planned for this endpoint
    End point values
    Placebo (T2DM) PF-07081532 20mg (T2DM) PF-07081532 40mg (T2DM) PF-07081532 80mg (T2DM) PF-07081532 160mg (T2DM) PF-07081532 260mg (T2DM) Rybelsus 14mg (T2DM)
    Number of subjects analysed
    75
    73
    72
    73
    72
    74
    73
    Units: Subjects
        Systolic Blood Pressure (mmHg) Value <90 mmHg
    0
    0
    0
    1
    1
    0
    0
        Systolic Blood Pressure (mmHg) Value >200 mmHg
    0
    0
    0
    0
    0
    0
    0
        Diastolic Blood Pressure (mmHg) Value <40 mmHg
    0
    0
    0
    0
    0
    0
    0
        Diastolic Blood Pressure (mmHg) Value >100 mmHg
    0
    4
    2
    2
    2
    1
    2
        Pulse Rate (bpm) Value <40 bpm
    0
    0
    0
    0
    0
    0
    0
        Pulse Rate (bpm) Value >110 bpm
    0
    1
    1
    0
    0
    1
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects With Vital Sign Abnormalities: Cohort 2 (Obesity)

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    End point title
    Number of Subjects With Vital Sign Abnormalities: Cohort 2 (Obesity) [88]
    End point description
    Vital signs included blood pressure and pulse rate and were measured with the subjects in a seated position after at least 5 minutes of rest for the subject. Criteria for abnormalities included: Systolic blood pressure (mmHg): value > 200 and value < 90; Diastolic blood pressure: value > 100 and < 40; Pulse rate: (BPM): value < 40 and > 110. Safety analysis set included all subjects randomly assigned to study intervention and who took at least 1 dose of study intervention. Subjects were analyzed according to the product they actually received.
    End point type
    Secondary
    End point timeframe
    Up to week 28
    Notes
    [88] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical Analysis was not planned for this endpoint
    End point values
    Placebo (Obesity) PF-07081532 80mg (Obesity) PF-07081532 140mg (Obesity) PF-07081532 200mg (Obesity,5 steps) PF-07081532 200mg (Obesity,4 steps) PF-07081532 260mg (Obesity)
    Number of subjects analysed
    64
    66
    64
    65
    66
    64
    Units: Subjects
        Systolic Blood Pressure (mmHg) Value <90 mmHg
    0
    3
    0
    2
    0
    1
        Systolic Blood Pressure (mmHg) Value >200 mmHg
    0
    0
    0
    0
    0
    0
        Diastolic Blood Pressure (mmHg) Value <40 mmHg
    0
    0
    0
    0
    0
    0
        Diastolic Blood Pressure (mmHg) Value >100 mmHg
    4
    4
    4
    0
    2
    3
        Pulse Rate (bpm) Value <40 bpm
    0
    0
    0
    0
    0
    0
        Pulse Rate (bpm) Value >110 bpm
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects With Clinical Laboratory Abnormalities: Cohort 1 (Type 2 Diabetes Mellitus)

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    End point title
    Number of Subjects With Clinical Laboratory Abnormalities: Cohort 1 (Type 2 Diabetes Mellitus) [89]
    End point description
    Hematology: platelets (10^9/L)< 0.5*lower limit of normal (LLN);leukocytes< 0.6*LLN and >1.5*upper limit of normal (ULN); lymphocytes and neutrophils <0.8*LLN and >1.2*ULN; basophils, eosinophils, monocytes:>1.2*ULN; prothrombin time (sec)>1.1*ULN; prothrombin international normalized ratio >1.1*ULN; clinical chemistry: bilirubin (mg/dL), indirect bilirubin:>1.5*ULN; aspartate and alanine aminotransferase, gamma glutamyl transferase (U/L):>3.0*ULN; urea nitrogen and creatinine (mg/dL)>1.3*ULN;HDL cholesterol (mg/dL)<0.8*LLN; LDL (mg/dL)>1.2*ULN, Triglycerides (mg/dL):>1.3*ULN;Potassium (milliequivalents per liter) < 0.9*LLN and >1.1*ULN;calcium (mg/dL)< 0.9*LLN,Thyroxine (nanograms/dL<0.8*LLN and >1.2*ULN, HbA1C (%)>1.3*ULN; Amylase, Lipase (U/L) and Glucose -Fasting (mg/dL)>1.5*ULN; urinalysis: pH> 8; urine glucose, ketones, protein, hemoglobin, nitrite and leukocyte esterase>=1. Number of participants with abnormalities in any of the laboratory parameters is reported. SAS was used.
    End point type
    Secondary
    End point timeframe
    Up to week 28
    Notes
    [89] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical Analysis was not planned for this endpoint
    End point values
    Placebo (T2DM) PF-07081532 20mg (T2DM) PF-07081532 40mg (T2DM) PF-07081532 80mg (T2DM) PF-07081532 160mg (T2DM) PF-07081532 260mg (T2DM) Rybelsus 14mg (T2DM)
    Number of subjects analysed
    75
    73
    72
    72
    71
    73
    73
    Units: Subjects
    67
    64
    57
    57
    61
    59
    64
    No statistical analyses for this end point

    Secondary: Number of Subjects With Clinical Laboratory Abnormalities: Cohort 2 (Obesity)

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    End point title
    Number of Subjects With Clinical Laboratory Abnormalities: Cohort 2 (Obesity) [90]
    End point description
    Hematology: platelets (10^9/L)< 0.5* LLN; leukocytes< 0.6*LLN and >1.5* ULN; lymphocytes and neutrophils <0.8*LLN and >1.2*ULN; basophils, eosinophils, monocytes:>1.2*ULN; prothrombin time (sec)>1.1*ULN; prothrombin international normalized ratio >1.1*ULN; clinical chemistry: bilirubin (mg/dL), indirect bilirubin:>1.5*ULN; aspartate and alanine aminotransferase, gamma glutamyl transferase (U/L):>3.0*ULN; urea nitrogen and creatinine (mg/dL)>1.3*ULN;HDL cholesterol (mg/dL)<0.8*LLN; LDL (mg/dL)>1.2*ULN, Triglycerides (mg/dL):>1.3*ULN; Potassium (milliequivalents per liter) < 0.9*LLN and >1.1*ULN; calcium (mg/dL)< 0.9*LLN, Thyroxine (nanograms/dL<0.8*LLN and >1.2*ULN, HbA1C (%)>1.3*ULN; Amylase, Lipase (U/L) and Glucose -Fasting (mg/dL)>1.5*ULN; urinalysis: pH> 8; urine glucose, ketones, protein, hemoglobin, nitrite and leukocyte esterase>=1. Number of participants with abnormalities in any of the laboratory parameters is reported. SAS was used.
    End point type
    Secondary
    End point timeframe
    Up to week 28
    Notes
    [90] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical Analysis was not planned for this endpoint
    End point values
    Placebo (Obesity) PF-07081532 80mg (Obesity) PF-07081532 140mg (Obesity) PF-07081532 200mg (Obesity,5 steps) PF-07081532 200mg (Obesity,4 steps) PF-07081532 260mg (Obesity)
    Number of subjects analysed
    64
    63
    63
    63
    66
    64
    Units: Subjects
    36
    31
    40
    40
    48
    36
    No statistical analyses for this end point

    Secondary: Number of Subjects With ECG Abnormalities: Cohort 1 (Type 2 Diabetes Mellitus)

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    End point title
    Number of Subjects With ECG Abnormalities: Cohort 1 (Type 2 Diabetes Mellitus) [91]
    End point description
    Standard 12-lead ECGs were performed after the subject had rested quietly for more than 10 minutes in a supine position utilizing an ECG machine that automatically calculated the heart rate and measured PR interval, QT interval, QTcF, and QRS complex. ECG abnormalities were categorized as: PR interval (msec), Value >= 300; %Chg >= 25/50%. QRS duration (msec): Value >= 140 and %Chg >= 50%. QT interval (msec): Value > 500; QTCF interval (msec): 450 < Value <= 480, 480 < Value <= 500, Value > 500; 30 <= Change (Chg) <= 60; Chg > 60. Safety analysis set included all subjects randomly assigned to study intervention and who took at least 1 dose of study intervention. Subjects were analyzed according to the product they actually received.
    End point type
    Secondary
    End point timeframe
    Up to week 28
    Notes
    [91] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical Analysis was not planned for this endpoint
    End point values
    Placebo (T2DM) PF-07081532 20mg (T2DM) PF-07081532 40mg (T2DM) PF-07081532 80mg (T2DM) PF-07081532 160mg (T2DM) PF-07081532 260mg (T2DM) Rybelsus 14mg (T2DM)
    Number of subjects analysed
    75
    73
    72
    73
    72
    74
    73
    Units: Subjects
        PR Interval, value>=300; n=75,73,71,73,71,73,72
    1
    0
    0
    1
    0
    0
    0
        PR Interval,Change>= 25/50%;n=75,73,71,73,71,73,72
    0
    0
    0
    0
    0
    0
    0
        QRS duration, Value≥140 n=75,73,72,73,72,74,73
    1
    0
    0
    1
    0
    0
    3
        QRS duration, Change >=50%; n=75,73,72,73,72,74,73
    0
    0
    0
    0
    0
    0
    0
        QT interval, value > 500; n=75,73,72,73,72,74,73
    0
    0
    0
    0
    0
    0
    0
        QTCF, 450 < Value <=480; n=75,73,72,73,72,74,73
    5
    7
    3
    5
    5
    2
    5
        QTCF, 480 <Value <=500; n=75,73,72,73,72,74,73
    0
    0
    0
    0
    0
    0
    1
        QTCF interval, Value > 500; n=75,73,72,73,72,74,73
    0
    0
    0
    0
    0
    0
    0
        QTCF, 30 <= Change <= 60; n=75,73,72,73,72,74,73
    3
    7
    5
    4
    3
    10
    8
        QTCF interval, Change > 60; n=75,73,72,73,72,74,73
    0
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects With ECG Abnormalities: Cohort 2 (Obesity)

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    End point title
    Number of Subjects With ECG Abnormalities: Cohort 2 (Obesity) [92]
    End point description
    Standard 12-lead ECGs were performed after the subject had rested quietly for more than 10 minutes in a supine position utilizing an ECG machine that automatically calculated the heart rate and measured PR interval, QT interval, QTcF, and QRS complex. ECG abnormalities were categorized as: PR interval msec, Value >= 300; percentage change (%) Chg >= 25/50%. QRS duration (msec): Value >= 140 and %Chg >= 50%. QT interval (msec): Value > 500; QTCF interval (msec): 450 < Value <= 480, 480 < Value <= 500, Value > 500; 30 <= change (Chg) <= 60; Chg > 60. Safety analysis set included all subjects randomly assigned to study intervention and who took at least 1 dose of study intervention. Subjects were analyzed according to the product they actually received.
    End point type
    Secondary
    End point timeframe
    Up to week 28
    Notes
    [92] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical Analysis was not planned for this endpoint
    End point values
    Placebo (Obesity) PF-07081532 80mg (Obesity) PF-07081532 140mg (Obesity) PF-07081532 200mg (Obesity,5 steps) PF-07081532 200mg (Obesity,4 steps) PF-07081532 260mg (Obesity)
    Number of subjects analysed
    64
    66
    64
    65
    66
    64
    Units: Subjects
        PR Interval, (MSEC) value >=300
    0
    0
    0
    0
    1
    0
        PR Interval, (MSEC) % Change >= 25/50%
    0
    0
    0
    0
    1
    0
        QRS duration, (MSEC) value >=140
    1
    0
    0
    0
    0
    0
        QRS duration, (MSEC) % Change >=50%
    0
    0
    0
    0
    0
    0
        QT interval, single beat (MSEC) value > 500
    0
    0
    0
    1
    0
    0
        QTCF interval, single beat (MSEC) 450 <Value <=480
    9
    3
    4
    2
    4
    7
        QTCF interval, single beat (MSEC) 480 <Value <=500
    0
    0
    0
    0
    0
    0
        QTCF interval, single beat (MSEC) Value > 500
    0
    0
    0
    0
    0
    0
        QTCF interval, single beat (MSEC) 30 <=Change<= 60
    3
    8
    4
    4
    4
    3
        QTCF interval, single beat (MSEC) Change > 60
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects According to Columbia-Suicide Severity Rating Scale (C-SSRS) Category: Cohort 2 (Obesity) Only

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    End point title
    Number of Subjects According to Columbia-Suicide Severity Rating Scale (C-SSRS) Category: Cohort 2 (Obesity) Only [93]
    End point description
    C-SSRS is an interview-based rating scale to assess suicidal ideation and behavior and had a binary response (yes/no). C-SSRS data was mapped to C-CASA per Guidance: Suicidal Ideation and Behavior: prospective assessment of occurrence in clinical trials. A subject was said to have suicidal behavior in case of any events:1) completed suicide; 2) suicide attempt 3) preparatory acts toward imminent suicidal behavior. A subject showed suicidal ideation if they responded ‘yes’ to any of the 5 questions, Wish to be dead; non-specific active suicidal thoughts active suicidal ideation with any methods (Not Plan) without Intent to Act; active suicidal ideation with some intent to act, without specific plan; Active suicidal ideation with specific plan and intent. Subjects was said to exhibit Self-injurious behavior, no suicidal intent if they responded as Yes to Has subject engaged in Non-suicidal Self-Injurious Behavior. SAS was used. This endpoint was planned to be assessed in Cohort 2 only.
    End point type
    Secondary
    End point timeframe
    Baseline (result closest prior to dosing on Day 1), anytime post-baseline (Up to Week 28)
    Notes
    [93] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical Analysis was not planned for this endpoint
    End point values
    Placebo (Obesity) PF-07081532 80mg (Obesity) PF-07081532 140mg (Obesity) PF-07081532 200mg (Obesity,5 steps) PF-07081532 200mg (Obesity,4 steps) PF-07081532 260mg (Obesity)
    Number of subjects analysed
    64
    66
    64
    65
    66
    64
    Units: Subjects
        Baseline: <1> Completed suicide
    0
    0
    0
    0
    0
    0
        Baseline: <2> Suicide attempt
    0
    0
    0
    0
    0
    0
        Baseline: <3> imminent suicidal behavior
    0
    0
    0
    0
    0
    0
        Baseline: <4> Suicidal ideation
    0
    0
    0
    0
    0
    1
        Baseline: <7> no suicidal intent
    0
    0
    0
    0
    0
    0
        Post-Baseline: <1> Completed suicide
    0
    0
    0
    0
    0
    0
        Post-Baseline: <2> Suicide attempt
    0
    0
    0
    0
    0
    0
        Post-Baseline: < 3 > imminent suicidal behavior
    1
    0
    0
    0
    0
    0
        Post-Baseline: <4> Suicidal ideation
    0
    0
    0
    0
    0
    1
        Post-Baseline: < 7 > no suicidal intent
    1
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Other pre-specified: Placebo-adjusted, Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 16: Cohort 1 (Type 2 Diabetes Mellitus)

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    End point title
    Placebo-adjusted, Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 16: Cohort 1 (Type 2 Diabetes Mellitus) [94]
    End point description
    Analysis was performed using mixed model repeated measures (MMRM) model including treatment, gender strata and time as fixed effects, baseline*time interaction, time*treatment interaction, and baseline as a covariate with time fitted as a repeated effect and participant as a random effect. Evaluable set included all subjects randomly assigned to study intervention and who took at least 1 dose of study intervention. Subjects were analyzed according to randomized intervention. Here, “Number of Subjects Analyzed” refers to subjects evaluable for this endpoint.
    End point type
    Other pre-specified
    End point timeframe
    Baseline (Baseline is defined as the result closest prior to dosing at Visit 3 (Day 1) at Week 16
    Notes
    [94] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical Analysis was not planned for this endpoint
    End point values
    Placebo (T2DM) PF-07081532 20mg (T2DM) PF-07081532 40mg (T2DM) PF-07081532 80mg (T2DM) PF-07081532 160mg (T2DM) PF-07081532 260mg (T2DM) Rybelsus 14mg (T2DM)
    Number of subjects analysed
    24
    30
    21
    22
    25
    21
    24
    Units: Percentage of HbA1c
        least squares mean (standard error)
    -0.07 ( 0.109 )
    -1.03 ( 0.106 )
    -1.37 ( 0.112 )
    -1.44 ( 0.111 )
    -1.34 ( 0.110 )
    -1.36 ( 0.114 )
    -0.94 ( 0.109 )
    Statistical analysis title
    Placebo (T2DM) and PF-07081532 20mg (T2DM)
    Comparison groups
    Placebo (T2DM) v PF-07081532 20mg (T2DM)
    Number of subjects included in analysis
    54
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    < 0.0001
    Method
    Mixed models analysis
    Parameter type
    LS Mean Difference
    Point estimate
    -0.95
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -1.2
         upper limit
    -0.7
    Statistical analysis title
    Placebo (T2DM) and PF-07081532 40mg (T2DM)
    Comparison groups
    Placebo (T2DM) v PF-07081532 40mg (T2DM)
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    < 0.0001
    Method
    Mixed models analysis
    Parameter type
    LS Mean Difference
    Point estimate
    -1.3
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -1.55
         upper limit
    -1.04
    Statistical analysis title
    Placebo (T2DM) and PF-07081532 260mg (T2DM)
    Comparison groups
    Placebo (T2DM) v PF-07081532 260mg (T2DM)
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    < 0.0001
    Method
    Mixed models analysis
    Parameter type
    LS Mean Difference
    Point estimate
    -1.29
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -1.55
         upper limit
    -1.03
    Statistical analysis title
    Placebo (T2DM) and PF-07081532 160mg (T2DM)
    Comparison groups
    Placebo (T2DM) v PF-07081532 160mg (T2DM)
    Number of subjects included in analysis
    49
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    < 0.0001
    Method
    Mixed models analysis
    Parameter type
    LS Mean Difference
    Point estimate
    -1.26
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -1.52
         upper limit
    -1.01
    Statistical analysis title
    Placebo (T2DM) and Rybelsus 14 mg (Obesity)
    Comparison groups
    Placebo (T2DM) v Rybelsus 14mg (T2DM)
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    < 0.0001
    Method
    Mixed models analysis
    Parameter type
    LS Mean Difference
    Point estimate
    -0.86
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -1.12
         upper limit
    -0.61
    Statistical analysis title
    Placebo (T2DM) and PF-07081532 80mg (T2DM)
    Comparison groups
    Placebo (T2DM) v PF-07081532 80mg (T2DM)
    Number of subjects included in analysis
    46
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    < 0.0001
    Method
    Mixed models analysis
    Parameter type
    LS Mean Difference
    Point estimate
    -1.37
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -1.62
         upper limit
    -1.11

    Other pre-specified: Placebo-adjusted, Percent Change From Baseline in Body Weight at Week 20: Cohort 2 (Obesity)

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    End point title
    Placebo-adjusted, Percent Change From Baseline in Body Weight at Week 20: Cohort 2 (Obesity) [95]
    End point description
    Body weight was measured using a calibrated weighing scale. Analysis was performed using MMRM model including treatment, gender strata and time as fixed effects, baseline*time interaction, time*treatment interaction, and baseline as a covariate with time fitted as a repeated effect and participant as a random effect. Evaluable set included all subjects randomly assigned to study intervention and who took at least 1 dose of study intervention. Subjects were analyzed according to randomized intervention. Here, “Number of Subjects Analyzed” refers to subjects evaluable for this endpoint.
    End point type
    Other pre-specified
    End point timeframe
    Baseline (Baseline is defined as the result closest prior to dosing at Visit 3 (Day 1), at Week 20
    Notes
    [95] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical Analysis was not planned for this endpoint
    End point values
    Placebo (Obesity) PF-07081532 80mg (Obesity) PF-07081532 140mg (Obesity) PF-07081532 200mg (Obesity,5 steps) PF-07081532 200mg (Obesity,4 steps) PF-07081532 260mg (Obesity)
    Number of subjects analysed
    45
    44
    37
    38
    31
    28
    Units: Percent change
        least squares mean (standard error)
    -1.84 ( 0.612 )
    -4.28 ( 0.623 )
    -6.21 ( 0.654 )
    -7.47 ( 0.628 )
    -6.88 ( 0.638 )
    -7.26 ( 0.664 )
    Statistical analysis title
    Placebo (Obesity) and PF-07081532 80mg (Obesity)
    Comparison groups
    Placebo (Obesity) v PF-07081532 80mg (Obesity)
    Number of subjects included in analysis
    89
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.0055
    Method
    Mixed models analysis
    Parameter type
    LS Mean Difference
    Point estimate
    -2.44
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -3.88
         upper limit
    -1
    Statistical analysis title
    Placebo (Obesity) and PF-07081532 140mg (Obesity)
    Comparison groups
    Placebo (Obesity) v PF-07081532 140mg (Obesity)
    Number of subjects included in analysis
    82
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    < 0.0001
    Method
    Mixed models analysis
    Parameter type
    LS Mean Difference
    Point estimate
    -4.37
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -5.84
         upper limit
    -2.89
    Statistical analysis title
    Placebo (Obesity), PF-07081532 200mg (5 steps)
    Comparison groups
    Placebo (Obesity) v PF-07081532 200mg (Obesity,5 steps)
    Number of subjects included in analysis
    83
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    < 0.0001
    Method
    Mixed models analysis
    Parameter type
    LS Mean Difference
    Point estimate
    -5.63
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -7.07
         upper limit
    -4.18
    Statistical analysis title
    Placebo (Obesity) & PF-07081532 200mg (4 steps)
    Comparison groups
    Placebo (Obesity) v PF-07081532 200mg (Obesity,4 steps)
    Number of subjects included in analysis
    76
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    < 0.0001
    Method
    Mixed models analysis
    Parameter type
    LS Mean Difference
    Point estimate
    -5.04
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -6.5
         upper limit
    -3.58
    Statistical analysis title
    Placebo (Obesity) and PF-07081532 260mg (Obesity)
    Comparison groups
    Placebo (Obesity) v PF-07081532 260mg (Obesity)
    Number of subjects included in analysis
    73
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    < 0.0001
    Method
    Mixed models analysis
    Parameter type
    LS Mean Difference
    Point estimate
    -5.42
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -6.91
         upper limit
    -3.93

    Other pre-specified: Change From Baseline in Fasting Plasma Glucose (FPG) at Week 16: Cohort 1 (Type 2 Diabetes Mellitus)

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    End point title
    Change From Baseline in Fasting Plasma Glucose (FPG) at Week 16: Cohort 1 (Type 2 Diabetes Mellitus) [96]
    End point description
    Evaluable set included all subjects randomly assigned to study intervention and who took at least 1 dose of study intervention. Subjects were analyzed according to randomized intervention. Here, “Number of Subjects Analyzed” refers to subjects evaluable for this endpoint.
    End point type
    Other pre-specified
    End point timeframe
    Baseline (Baseline is defined as the result closest prior to dosing at Visit 3 (Day 1), at Week 16
    Notes
    [96] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical Analysis was not planned for this endpoint
    End point values
    Placebo (T2DM) PF-07081532 20mg (T2DM) PF-07081532 40mg (T2DM) PF-07081532 80mg (T2DM) PF-07081532 160mg (T2DM) PF-07081532 260mg (T2DM) Rybelsus 14mg (T2DM)
    Number of subjects analysed
    24
    30
    21
    22
    25
    21
    24
    Units: Milligrams per deciliter
        arithmetic mean (standard deviation)
    160.70 ( 39.595 )
    135.59 ( 31.746 )
    127.00 ( 35.928 )
    132.19 ( 31.541 )
    127.65 ( 28.839 )
    125.07 ( 46.924 )
    130.06 ( 28.120 )
    No statistical analyses for this end point

    Other pre-specified: Percent Change From Baseline in Body Weight at Week 16: Cohort 1 (Type 2 Diabetes Mellitus)

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    End point title
    Percent Change From Baseline in Body Weight at Week 16: Cohort 1 (Type 2 Diabetes Mellitus) [97]
    End point description
    Body weight was measured using a calibrated weighing scale. Evaluable set included all subjects randomly assigned to study intervention and who took at least 1 dose of study intervention. Subjects were analyzed according to randomized intervention. Here, “Number of Subjects Analyzed” refers to subjects evaluable for this endpoint.
    End point type
    Other pre-specified
    End point timeframe
    Baseline (Baseline is defined as the result closest prior to dosing at Visit 3 (Day 1), at Week 16
    Notes
    [97] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical Analysis was not planned for this endpoint
    End point values
    Placebo (T2DM) PF-07081532 20mg (T2DM) PF-07081532 40mg (T2DM) PF-07081532 80mg (T2DM) PF-07081532 160mg (T2DM) PF-07081532 260mg (T2DM) Rybelsus 14mg (T2DM)
    Number of subjects analysed
    29
    32
    30
    28
    28
    30
    27
    Units: Percent change
        arithmetic mean (standard deviation)
    93.164 ( 22.0659 )
    86.251 ( 17.3464 )
    91.556 ( 23.4071 )
    92.979 ( 24.5045 )
    85.564 ( 17.9582 )
    87.658 ( 21.6950 )
    91.799 ( 20.4605 )
    No statistical analyses for this end point

    Other pre-specified: Placebo-adjusted, Change From Baseline in Percentage of HbA1C in the Rybelsus arm Versus Placebo arm at Week 16: Cohort 1 (Type 2 Diabetes Mellitus)

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    End point title
    Placebo-adjusted, Change From Baseline in Percentage of HbA1C in the Rybelsus arm Versus Placebo arm at Week 16: Cohort 1 (Type 2 Diabetes Mellitus) [98]
    End point description
    Analysis was performed using MMRM model including treatment, gender strata and time as fixed effects, baseline*time interaction, time*treatment interaction, and baseline as a covariate with time fitted as a repeated effect and participant as a random effect. Evaluable set included all subjects randomly assigned to study intervention and who took at least 1 dose of study intervention. Subjects were analyzed according to randomized intervention. This endpoint was planned to be analyzed only for rybelsus arm and placebo arm as pre-specified in the protocol.
    End point type
    Other pre-specified
    End point timeframe
    Baseline (Baseline is defined as the result closest prior to dosing at Visit 3 (Day 1), at Week 16
    Notes
    [98] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical Analysis was not planned for this endpoint
    End point values
    Placebo (T2DM) Rybelsus 14mg (T2DM)
    Number of subjects analysed
    24
    24
    Units: Percentage of HbA1C
        least squares mean (standard error)
    -0.07 ( 0.109 )
    -0.94 ( 0.109 )
    Statistical analysis title
    Rybelsus 14 mg (T2DM) and Placebo (T2DM)
    Comparison groups
    Rybelsus 14mg (T2DM) v Placebo (T2DM)
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    < 0.0001
    Method
    Mixed models analysis
    Parameter type
    LS Mean Difference
    Point estimate
    -0.86
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -1.12
         upper limit
    -0.61

    Other pre-specified: Absolute Change From Baseline in Waist Circumference at Week 12 and 24: Cohort 2 (Obesity)

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    End point title
    Absolute Change From Baseline in Waist Circumference at Week 12 and 24: Cohort 2 (Obesity) [99]
    End point description
    Waist circumference was measured at midpoint, between lower margin of last palpable rib and top of iliac crest (approximately 1 inch [2.54 cm] above the navel). It was measured by using an anthropometric tape (stretch-resistant). Evaluable set included all subjects randomly assigned to study intervention and who took at least 1 dose of study intervention. Subjects were analyzed according to randomized intervention. Here, “Number of Subjects Analyzed” refers to subjects evaluable for this endpoint. N=subjects evaluable for specified timepoints.
    End point type
    Other pre-specified
    End point timeframe
    Baseline (Baseline is defined as the result closest prior to dosing at Visit 3 (Day 1), at Week 12, 24
    Notes
    [99] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical Analysis was not planned for this endpoint
    End point values
    Placebo (Obesity) PF-07081532 80mg (Obesity) PF-07081532 140mg (Obesity) PF-07081532 200mg (Obesity,5 steps) PF-07081532 200mg (Obesity,4 steps) PF-07081532 260mg (Obesity)
    Number of subjects analysed
    57
    53
    49
    56
    53
    50
    Units: Cm
    arithmetic mean (standard deviation)
        Week 12; n=57,53,49,56,53,50
    -2.702 ( 4.1726 )
    -2.574 ( 5.0872 )
    -3.017 ( 5.9117 )
    -3.559 ( 6.5122 )
    -2.191 ( 5.2942 )
    -1.079 ( 4.6710 )
        Week 24; n=12,12,11,9,7,4
    -4.233 ( 5.3953 )
    -5.147 ( 4.1807 )
    -6.314 ( 10.2170 )
    -2.722 ( 7.6706 )
    -10.297 ( 7.7652 )
    -6.450 ( 4.2123 )
    No statistical analyses for this end point

    Other pre-specified: Absolute Change From Baseline in Waist-to-hip Ratio at Week 12 and Week 24: Cohort 2 (Obesity)

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    End point title
    Absolute Change From Baseline in Waist-to-hip Ratio at Week 12 and Week 24: Cohort 2 (Obesity) [100]
    End point description
    The hip circumference was defined as the circumference around the widest portion of the buttocks. Waist circumference was measured at midpoint, between lower margin of last palpable rib and top of iliac crest (approximately 1 inch [2.54 cm] above the navel). The measurements were performed using an anthropometric tape (stretch-resistant). Evaluable set included all subjects randomly assigned to study intervention and who took at least 1 dose of study intervention. Subjects were analyzed according to randomized intervention. Here, “Number of Subjects Analyzed” refers to subjects evaluable for this endpoint.
    End point type
    Other pre-specified
    End point timeframe
    Baseline (Baseline is defined as the result closest prior to dosing at Visit 3 (Day 1), at week 12, 24
    Notes
    [100] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical Analysis was not planned for this endpoint
    End point values
    Placebo (Obesity) PF-07081532 80mg (Obesity) PF-07081532 140mg (Obesity) PF-07081532 200mg (Obesity,5 steps) PF-07081532 200mg (Obesity,4 steps) PF-07081532 260mg (Obesity)
    Number of subjects analysed
    57
    53
    49
    56
    53
    50
    Units: Ratio
    arithmetic mean (standard deviation)
        Week 12
    -0.013 ( 0.0374 )
    -0.002 ( 0.0459 )
    -0.006 ( 0.0578 )
    -0.010 ( 0.0683 )
    -0.002 ( 0.0423 )
    0.015 ( 0.0557 )
        Week 24
    -0.023 ( 0.0419 )
    -0.017 ( 0.0250 )
    -0.032 ( 0.0588 )
    0.018 ( 0.0563 )
    -0.009 ( 0.0498 )
    -0.037 ( 0.0574 )
    No statistical analyses for this end point

    Other pre-specified: Change From Baseline in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) at Week 16: Cohort 2 (Obesity)

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    End point title
    Change From Baseline in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) at Week 16: Cohort 2 (Obesity) [101]
    End point description
    HOMA-IR was calculated as: ([FPI]*(FPG)/405 in terms of Mg/dL* (milliunits per liter). Evaluable set included all subjects randomly assigned to study intervention and who took at least 1 dose of study intervention. Subjects were analyzed according to randomized intervention. Here, “Number of Subjects Analyzed” refers to subjects evaluable for this endpoint.
    End point type
    Other pre-specified
    End point timeframe
    Baseline (Baseline is defined as the result closest prior to dosing at Visit 3 (Day 1), Week 16
    Notes
    [101] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical Analysis was not planned for this endpoint
    End point values
    Placebo (Obesity) PF-07081532 80mg (Obesity) PF-07081532 140mg (Obesity) PF-07081532 200mg (Obesity,5 steps) PF-07081532 200mg (Obesity,4 steps) PF-07081532 260mg (Obesity)
    Number of subjects analysed
    53
    48
    42
    46
    42
    39
    Units: Mg/dL* (milliunits per liter)
        arithmetic mean (standard deviation)
    0.630 ( 2.1753 )
    0.185 ( 2.0579 )
    -0.121 ( 4.7540 )
    0.984 ( 3.9090 )
    -1.172 ( 2.7360 )
    -0.210 ( 1.1373 )
    No statistical analyses for this end point

    Other pre-specified: Change From Baseline in Homeostatic Model Assessment for Insulin Sensitivity (HOMA-S) at Week 16: Cohort 2 (Obesity)

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    End point title
    Change From Baseline in Homeostatic Model Assessment for Insulin Sensitivity (HOMA-S) at Week 16: Cohort 2 (Obesity) [102]
    End point description
    HOMA-S was calculated as (22.5/[FPI]*FPG)) *100 and measured in terms of percentage sensitivity. Evaluable set included all subjects randomly assigned to study intervention and who took at least 1 dose of study intervention. Subjects were analyzed according to randomized intervention. Here, “Number of Subjects Analyzed” refers to subjects evaluable for this endpoint.
    End point type
    Other pre-specified
    End point timeframe
    Baseline (Baseline is defined as the result closest prior to dosing at Visit 3 (Day 1), Week 16
    Notes
    [102] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical Analysis was not planned for this endpoint
    End point values
    Placebo (Obesity) PF-07081532 80mg (Obesity) PF-07081532 140mg (Obesity) PF-07081532 200mg (Obesity,5 steps) PF-07081532 200mg (Obesity,4 steps) PF-07081532 260mg (Obesity)
    Number of subjects analysed
    53
    48
    42
    46
    42
    39
    Units: Percentage sensitivity
        arithmetic mean (standard deviation)
    -2.419 ( 51.8526 )
    1.594 ( 24.1848 )
    7.807 ( 26.5041 )
    -7.085 ( 21.6406 )
    3.497 ( 68.2570 )
    -2.045 ( 28.8973 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Part 1 and 2: From start of treatment up to minimum of 28 days after last dose of treatment administration (maximum up to Week 28)
    Adverse event reporting additional description
    Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 subject and non-serious in other subject, or a subject may have experienced both SAE and non-SAE. Safety analysis set was used.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    v26.0
    Reporting groups
    Reporting group title
    PF-07081532 80mg (T2DM)
    Reporting group description
    Subjects with T2DM inadequately controlled with metformin were administered titrating doses of PF-07081532 20 mg QD, 40 mg QD and 60 mg QD orally for 4 weeks each followed by PF-07081532 80 mg QD orally.

    Reporting group title
    PF-07081532 40mg (T2DM)
    Reporting group description
    Subjects with T2DM inadequately controlled with metformin were administered PF-07081532 20 mg QD orally for 4 weeks followed by PF-07081532 40 mg QD orally.

    Reporting group title
    PF-07081532 20mg (T2DM)
    Reporting group description
    Subjects with T2DM inadequately controlled with metformin were administered PF-07081532 20 mg QD orally.

    Reporting group title
    Placebo (T2DM)
    Reporting group description
    Subjects with T2DM inadequately controlled with metformin were administered PF-07081532-matching placebo QD orally.

    Reporting group title
    PF-07081532 80mg (Obesity)
    Reporting group description
    Subjects with obesity were administered titrating doses of PF-07081532 20 mg QD, 40 mg QD and 60 mg QD orally for 4 weeks each followed by PF-07081532 80 mg QD orally.

    Reporting group title
    PF-07081532 140mg (Obesity)
    Reporting group description
    Subjects with obesity were administered titrating doses of PF-07081532 20 mg QD, 40 mg QD and 60 mg QD, 80 mg QD,120 mg QD orally for 4 weeks each followed by PF-07081532 140 mg QD orally.

    Reporting group title
    PF-07081532 200mg (Obesity,5 steps)
    Reporting group description
    Subjects with obesity were administered titrating doses of PF-07081532 20 mg QD, 40 mg QD and 60 mg QD, 100 mg QD,160 mg QD orally for 4 weeks each followed by PF-07081532 200 mg QD orally.

    Reporting group title
    PF-07081532 200mg (Obesity,4 steps)
    Reporting group description
    Subjects with obesity were administered titrating doses of PF-07081532 20 mg QD, 40 mg QD and 80 mg QD, 140 mg QD orally for 4 weeks each followed by PF-07081532 200 mg QD orally.

    Reporting group title
    Placebo (Obesity)
    Reporting group description
    Subjects with obesity were administered a single dose of PF-07081532-matching placebo QD orally.

    Reporting group title
    PF-07081532 260mg (Obesity)
    Reporting group description
    Subjects with obesity were administered titrating doses of PF-07081532 20 mg QD, 40 mg QD and 80 mg QD, 140 mg QD, 200 mg QD orally for 4 weeks each followed by PF-07081532 260 mg QD orally.

    Reporting group title
    PF-07081532 260mg (T2DM)
    Reporting group description
    Subjects with T2DM inadequately controlled with metformin were administered titrating doses of PF-07081532 20 mg QD, 40 mg QD, 80 mg QD, 140 mg QD and 200 mg QD orally for 4 weeks each followed by PF-07081532 260 mg QD orally.

    Reporting group title
    PF-07081532 160mg (T2DM)
    Reporting group description
    Subjects with T2DM inadequately controlled with metformin were administered titrating doses of PF-07081532 20 mg QD 40 mg QD, 60 mg QD, 80 mg QD and 120 mg QD orally for 4 weeks each followed by PF-07081532 160 mg QD orally.

    Reporting group title
    Rybelsus 14mg (T2DM)
    Reporting group description
    Subjects with T2DM inadequately controlled with metformin were administered titrating doses of Rybelsus 3 mg QD and 7 mg QD each for 4 weeks followed by 14 mg QD.

    Serious adverse events
    PF-07081532 80mg (T2DM) PF-07081532 40mg (T2DM) PF-07081532 20mg (T2DM) Placebo (T2DM) PF-07081532 80mg (Obesity) PF-07081532 140mg (Obesity) PF-07081532 200mg (Obesity,5 steps) PF-07081532 200mg (Obesity,4 steps) Placebo (Obesity) PF-07081532 260mg (Obesity) PF-07081532 260mg (T2DM) PF-07081532 160mg (T2DM) Rybelsus 14mg (T2DM)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 73 (4.11%)
    3 / 72 (4.17%)
    0 / 73 (0.00%)
    1 / 75 (1.33%)
    2 / 66 (3.03%)
    2 / 64 (3.13%)
    1 / 65 (1.54%)
    2 / 66 (3.03%)
    1 / 64 (1.56%)
    2 / 64 (3.13%)
    2 / 74 (2.70%)
    1 / 72 (1.39%)
    1 / 73 (1.37%)
         number of deaths (all causes)
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
    0 / 75 (0.00%)
    0 / 66 (0.00%)
    0 / 64 (0.00%)
    0 / 65 (0.00%)
    1 / 66 (1.52%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 74 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood alkaline phosphatase increased
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
    0 / 75 (0.00%)
    0 / 66 (0.00%)
    0 / 64 (0.00%)
    0 / 65 (0.00%)
    1 / 66 (1.52%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 74 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Liver function test abnormal
         subjects affected / exposed
    1 / 73 (1.37%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
    0 / 75 (0.00%)
    0 / 66 (0.00%)
    0 / 64 (0.00%)
    0 / 65 (0.00%)
    0 / 66 (0.00%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 74 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Liver function test increased
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
    0 / 75 (0.00%)
    0 / 66 (0.00%)
    0 / 64 (0.00%)
    0 / 65 (0.00%)
    0 / 66 (0.00%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    1 / 74 (1.35%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Carcinoid tumour
         subjects affected / exposed
    1 / 73 (1.37%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
    0 / 75 (0.00%)
    0 / 66 (0.00%)
    0 / 64 (0.00%)
    0 / 65 (0.00%)
    0 / 66 (0.00%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 74 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
    0 / 75 (0.00%)
    0 / 66 (0.00%)
    1 / 64 (1.56%)
    0 / 65 (0.00%)
    0 / 66 (0.00%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 74 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
    0 / 75 (0.00%)
    0 / 66 (0.00%)
    0 / 64 (0.00%)
    0 / 65 (0.00%)
    0 / 66 (0.00%)
    1 / 64 (1.56%)
    0 / 64 (0.00%)
    0 / 74 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
    1 / 75 (1.33%)
    0 / 66 (0.00%)
    0 / 64 (0.00%)
    0 / 65 (0.00%)
    0 / 66 (0.00%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 74 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myocardial ischaemia
         subjects affected / exposed
    0 / 73 (0.00%)
    1 / 72 (1.39%)
    0 / 73 (0.00%)
    0 / 75 (0.00%)
    0 / 66 (0.00%)
    0 / 64 (0.00%)
    0 / 65 (0.00%)
    0 / 66 (0.00%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 74 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ventricular extrasystoles
         subjects affected / exposed
    0 / 73 (0.00%)
    1 / 72 (1.39%)
    0 / 73 (0.00%)
    0 / 75 (0.00%)
    0 / 66 (0.00%)
    0 / 64 (0.00%)
    0 / 65 (0.00%)
    0 / 66 (0.00%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 74 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Ischaemic stroke
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
    0 / 75 (0.00%)
    0 / 66 (0.00%)
    0 / 64 (0.00%)
    0 / 65 (0.00%)
    0 / 66 (0.00%)
    0 / 64 (0.00%)
    1 / 64 (1.56%)
    0 / 74 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
    0 / 75 (0.00%)
    0 / 66 (0.00%)
    0 / 64 (0.00%)
    0 / 65 (0.00%)
    0 / 66 (0.00%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 74 (0.00%)
    0 / 72 (0.00%)
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
    0 / 75 (0.00%)
    0 / 66 (0.00%)
    1 / 64 (1.56%)
    0 / 65 (0.00%)
    0 / 66 (0.00%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 74 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
    0 / 75 (0.00%)
    0 / 66 (0.00%)
    0 / 64 (0.00%)
    0 / 65 (0.00%)
    0 / 66 (0.00%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    1 / 74 (1.35%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Small intestinal obstruction
         subjects affected / exposed
    1 / 73 (1.37%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
    0 / 75 (0.00%)
    0 / 66 (0.00%)
    0 / 64 (0.00%)
    0 / 65 (0.00%)
    0 / 66 (0.00%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 74 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hypertransaminasaemia
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
    0 / 75 (0.00%)
    1 / 66 (1.52%)
    0 / 64 (0.00%)
    0 / 65 (0.00%)
    1 / 66 (1.52%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 74 (0.00%)
    1 / 72 (1.39%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis
         subjects affected / exposed
    0 / 73 (0.00%)
    1 / 72 (1.39%)
    0 / 73 (0.00%)
    0 / 75 (0.00%)
    0 / 66 (0.00%)
    0 / 64 (0.00%)
    0 / 65 (0.00%)
    0 / 66 (0.00%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 74 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Allergic respiratory symptom
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
    0 / 75 (0.00%)
    1 / 66 (1.52%)
    0 / 64 (0.00%)
    0 / 65 (0.00%)
    0 / 66 (0.00%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 74 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Epistaxis
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
    0 / 75 (0.00%)
    0 / 66 (0.00%)
    0 / 64 (0.00%)
    0 / 65 (0.00%)
    1 / 66 (1.52%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 74 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    COVID-19 pneumonia
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
    0 / 75 (0.00%)
    1 / 66 (1.52%)
    0 / 64 (0.00%)
    0 / 65 (0.00%)
    0 / 66 (0.00%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 74 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
    0 / 75 (0.00%)
    0 / 66 (0.00%)
    0 / 64 (0.00%)
    0 / 65 (0.00%)
    0 / 66 (0.00%)
    0 / 64 (0.00%)
    1 / 64 (1.56%)
    0 / 74 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
    0 / 75 (0.00%)
    1 / 66 (1.52%)
    0 / 64 (0.00%)
    0 / 65 (0.00%)
    0 / 66 (0.00%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 74 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Gout
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
    0 / 75 (0.00%)
    0 / 66 (0.00%)
    0 / 64 (0.00%)
    1 / 65 (1.54%)
    0 / 66 (0.00%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 74 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    PF-07081532 80mg (T2DM) PF-07081532 40mg (T2DM) PF-07081532 20mg (T2DM) Placebo (T2DM) PF-07081532 80mg (Obesity) PF-07081532 140mg (Obesity) PF-07081532 200mg (Obesity,5 steps) PF-07081532 200mg (Obesity,4 steps) Placebo (Obesity) PF-07081532 260mg (Obesity) PF-07081532 260mg (T2DM) PF-07081532 160mg (T2DM) Rybelsus 14mg (T2DM)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    37 / 73 (50.68%)
    46 / 72 (63.89%)
    31 / 73 (42.47%)
    23 / 75 (30.67%)
    50 / 66 (75.76%)
    48 / 64 (75.00%)
    55 / 65 (84.62%)
    59 / 66 (89.39%)
    42 / 64 (65.63%)
    53 / 64 (82.81%)
    51 / 74 (68.92%)
    41 / 72 (56.94%)
    32 / 73 (43.84%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
    0 / 75 (0.00%)
    2 / 66 (3.03%)
    0 / 64 (0.00%)
    1 / 65 (1.54%)
    2 / 66 (3.03%)
    4 / 64 (6.25%)
    1 / 64 (1.56%)
    0 / 74 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    1
    2
    4
    1
    0
    0
    0
    Flushing
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
    0 / 75 (0.00%)
    0 / 66 (0.00%)
    0 / 64 (0.00%)
    0 / 65 (0.00%)
    2 / 66 (3.03%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 74 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    Hypotension
         subjects affected / exposed
    0 / 73 (0.00%)
    1 / 72 (1.39%)
    0 / 73 (0.00%)
    0 / 75 (0.00%)
    0 / 66 (0.00%)
    2 / 64 (3.13%)
    0 / 65 (0.00%)
    2 / 66 (3.03%)
    0 / 64 (0.00%)
    1 / 64 (1.56%)
    0 / 74 (0.00%)
    2 / 72 (2.78%)
    0 / 73 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    2
    0
    2
    0
    1
    0
    2
    0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    1 / 73 (1.37%)
    4 / 72 (5.56%)
    0 / 73 (0.00%)
    0 / 75 (0.00%)
    7 / 66 (10.61%)
    5 / 64 (7.81%)
    6 / 65 (9.23%)
    5 / 66 (7.58%)
    5 / 64 (7.81%)
    5 / 64 (7.81%)
    2 / 74 (2.70%)
    2 / 72 (2.78%)
    2 / 73 (2.74%)
         occurrences all number
    1
    5
    0
    0
    11
    6
    9
    8
    5
    5
    2
    3
    2
    Asthenia
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
    0 / 75 (0.00%)
    0 / 66 (0.00%)
    2 / 64 (3.13%)
    0 / 65 (0.00%)
    1 / 66 (1.52%)
    0 / 64 (0.00%)
    2 / 64 (3.13%)
    0 / 74 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    2
    0
    1
    0
    2
    0
    0
    0
    Chest discomfort
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
    0 / 75 (0.00%)
    1 / 66 (1.52%)
    0 / 64 (0.00%)
    0 / 65 (0.00%)
    0 / 66 (0.00%)
    2 / 64 (3.13%)
    1 / 64 (1.56%)
    0 / 74 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    0
    0
    2
    1
    0
    0
    0
    Early satiety
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
    0 / 75 (0.00%)
    0 / 66 (0.00%)
    2 / 64 (3.13%)
    0 / 65 (0.00%)
    1 / 66 (1.52%)
    0 / 64 (0.00%)
    2 / 64 (3.13%)
    0 / 74 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    2
    0
    1
    0
    2
    0
    0
    0
    Pain
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
    0 / 75 (0.00%)
    0 / 66 (0.00%)
    0 / 64 (0.00%)
    0 / 65 (0.00%)
    0 / 66 (0.00%)
    0 / 64 (0.00%)
    2 / 64 (3.13%)
    0 / 74 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Nasal congestion
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
    0 / 75 (0.00%)
    1 / 66 (1.52%)
    0 / 64 (0.00%)
    1 / 65 (1.54%)
    0 / 66 (0.00%)
    2 / 64 (3.13%)
    0 / 64 (0.00%)
    0 / 74 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    1
    0
    2
    0
    0
    0
    0
    Cough
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 72 (0.00%)
    2 / 73 (2.74%)
    0 / 75 (0.00%)
    0 / 66 (0.00%)
    0 / 64 (0.00%)
    0 / 65 (0.00%)
    0 / 66 (0.00%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 74 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Oropharyngeal pain
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
    0 / 75 (0.00%)
    0 / 66 (0.00%)
    0 / 64 (0.00%)
    1 / 65 (1.54%)
    1 / 66 (1.52%)
    3 / 64 (4.69%)
    1 / 64 (1.56%)
    0 / 74 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    1
    3
    1
    0
    0
    0
    Sinus congestion
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
    0 / 75 (0.00%)
    1 / 66 (1.52%)
    1 / 64 (1.56%)
    2 / 65 (3.08%)
    1 / 66 (1.52%)
    1 / 64 (1.56%)
    0 / 64 (0.00%)
    0 / 74 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    2
    1
    1
    0
    0
    0
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
    0 / 75 (0.00%)
    3 / 66 (4.55%)
    0 / 64 (0.00%)
    0 / 65 (0.00%)
    0 / 66 (0.00%)
    2 / 64 (3.13%)
    0 / 64 (0.00%)
    0 / 74 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    0
    0
    0
    0
    3
    0
    0
    0
    2
    0
    0
    0
    0
    Insomnia
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
    0 / 75 (0.00%)
    1 / 66 (1.52%)
    0 / 64 (0.00%)
    3 / 65 (4.62%)
    1 / 66 (1.52%)
    0 / 64 (0.00%)
    2 / 64 (3.13%)
    0 / 74 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    3
    3
    0
    2
    0
    0
    0
    Depressed mood
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
    0 / 75 (0.00%)
    0 / 66 (0.00%)
    0 / 64 (0.00%)
    1 / 65 (1.54%)
    1 / 66 (1.52%)
    2 / 64 (3.13%)
    0 / 64 (0.00%)
    0 / 74 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    1
    2
    0
    0
    0
    0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    2 / 73 (2.74%)
    1 / 72 (1.39%)
    0 / 73 (0.00%)
    0 / 75 (0.00%)
    1 / 66 (1.52%)
    2 / 64 (3.13%)
    1 / 65 (1.54%)
    4 / 66 (6.06%)
    2 / 64 (3.13%)
    1 / 64 (1.56%)
    2 / 74 (2.70%)
    1 / 72 (1.39%)
    0 / 73 (0.00%)
         occurrences all number
    2
    1
    0
    0
    1
    2
    1
    4
    2
    1
    2
    1
    0
    Lipase increased
         subjects affected / exposed
    1 / 73 (1.37%)
    4 / 72 (5.56%)
    3 / 73 (4.11%)
    0 / 75 (0.00%)
    2 / 66 (3.03%)
    0 / 64 (0.00%)
    0 / 65 (0.00%)
    1 / 66 (1.52%)
    0 / 64 (0.00%)
    2 / 64 (3.13%)
    3 / 74 (4.05%)
    0 / 72 (0.00%)
    3 / 73 (4.11%)
         occurrences all number
    1
    5
    3
    0
    2
    0
    0
    2
    0
    2
    3
    0
    3
    Aspartate aminotransferase increased
         subjects affected / exposed
    2 / 73 (2.74%)
    1 / 72 (1.39%)
    0 / 73 (0.00%)
    0 / 75 (0.00%)
    1 / 66 (1.52%)
    2 / 64 (3.13%)
    0 / 65 (0.00%)
    3 / 66 (4.55%)
    1 / 64 (1.56%)
    1 / 64 (1.56%)
    0 / 74 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    2
    1
    0
    0
    1
    2
    0
    3
    1
    1
    0
    0
    0
    Liver function test increased
         subjects affected / exposed
    2 / 73 (2.74%)
    1 / 72 (1.39%)
    0 / 73 (0.00%)
    0 / 75 (0.00%)
    0 / 66 (0.00%)
    0 / 64 (0.00%)
    0 / 65 (0.00%)
    0 / 66 (0.00%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    1 / 74 (1.35%)
    1 / 72 (1.39%)
    0 / 73 (0.00%)
         occurrences all number
    2
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    Hepatic enzyme increased
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
    0 / 75 (0.00%)
    0 / 66 (0.00%)
    0 / 64 (0.00%)
    0 / 65 (0.00%)
    0 / 66 (0.00%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    1 / 74 (1.35%)
    2 / 72 (2.78%)
    0 / 73 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    2
    0
    Amylase increased
         subjects affected / exposed
    1 / 73 (1.37%)
    2 / 72 (2.78%)
    0 / 73 (0.00%)
    0 / 75 (0.00%)
    0 / 66 (0.00%)
    0 / 64 (0.00%)
    0 / 65 (0.00%)
    0 / 66 (0.00%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 74 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    1
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
    0 / 75 (0.00%)
    1 / 66 (1.52%)
    0 / 64 (0.00%)
    0 / 65 (0.00%)
    2 / 66 (3.03%)
    1 / 64 (1.56%)
    0 / 64 (0.00%)
    0 / 74 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    2
    1
    0
    0
    0
    0
    Ligament sprain
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
    0 / 75 (0.00%)
    0 / 66 (0.00%)
    0 / 64 (0.00%)
    0 / 65 (0.00%)
    0 / 66 (0.00%)
    2 / 64 (3.13%)
    0 / 64 (0.00%)
    0 / 74 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    Cardiac disorders
    Ventricular extrasystoles
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 72 (0.00%)
    2 / 73 (2.74%)
    0 / 75 (0.00%)
    0 / 66 (0.00%)
    0 / 64 (0.00%)
    0 / 65 (0.00%)
    0 / 66 (0.00%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 74 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    0
    0
    3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Palpitations
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
    0 / 75 (0.00%)
    0 / 66 (0.00%)
    1 / 64 (1.56%)
    0 / 65 (0.00%)
    0 / 66 (0.00%)
    2 / 64 (3.13%)
    0 / 64 (0.00%)
    0 / 74 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    2
    0
    0
    0
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 73 (1.37%)
    1 / 72 (1.39%)
    0 / 73 (0.00%)
    2 / 75 (2.67%)
    4 / 66 (6.06%)
    2 / 64 (3.13%)
    1 / 65 (1.54%)
    4 / 66 (6.06%)
    3 / 64 (4.69%)
    4 / 64 (6.25%)
    7 / 74 (9.46%)
    2 / 72 (2.78%)
    0 / 73 (0.00%)
         occurrences all number
    2
    1
    0
    2
    5
    2
    1
    6
    3
    4
    8
    2
    0
    Headache
         subjects affected / exposed
    2 / 73 (2.74%)
    5 / 72 (6.94%)
    2 / 73 (2.74%)
    0 / 75 (0.00%)
    7 / 66 (10.61%)
    4 / 64 (6.25%)
    7 / 65 (10.77%)
    9 / 66 (13.64%)
    5 / 64 (7.81%)
    5 / 64 (7.81%)
    1 / 74 (1.35%)
    1 / 72 (1.39%)
    2 / 73 (2.74%)
         occurrences all number
    3
    5
    2
    0
    9
    4
    11
    21
    5
    8
    1
    1
    2
    Dysgeusia
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 72 (0.00%)
    2 / 73 (2.74%)
    0 / 75 (0.00%)
    0 / 66 (0.00%)
    0 / 64 (0.00%)
    0 / 65 (0.00%)
    0 / 66 (0.00%)
    0 / 64 (0.00%)
    2 / 64 (3.13%)
    0 / 74 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    Migraine
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
    0 / 75 (0.00%)
    1 / 66 (1.52%)
    1 / 64 (1.56%)
    2 / 65 (3.08%)
    1 / 66 (1.52%)
    1 / 64 (1.56%)
    0 / 64 (0.00%)
    0 / 74 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    2
    1
    1
    0
    0
    0
    0
    Head discomfort
         subjects affected / exposed
    0 / 73 (0.00%)
    2 / 72 (2.78%)
    0 / 73 (0.00%)
    0 / 75 (0.00%)
    0 / 66 (0.00%)
    0 / 64 (0.00%)
    0 / 65 (0.00%)
    0 / 66 (0.00%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 74 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
    0 / 75 (0.00%)
    0 / 66 (0.00%)
    0 / 64 (0.00%)
    0 / 65 (0.00%)
    0 / 66 (0.00%)
    0 / 64 (0.00%)
    2 / 64 (3.13%)
    0 / 74 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    Thrombocytopenia
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
    0 / 75 (0.00%)
    0 / 66 (0.00%)
    0 / 64 (0.00%)
    0 / 65 (0.00%)
    0 / 66 (0.00%)
    0 / 64 (0.00%)
    2 / 64 (3.13%)
    0 / 74 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    2 / 73 (2.74%)
    5 / 72 (6.94%)
    1 / 73 (1.37%)
    0 / 75 (0.00%)
    2 / 66 (3.03%)
    3 / 64 (4.69%)
    1 / 65 (1.54%)
    3 / 66 (4.55%)
    4 / 64 (6.25%)
    4 / 64 (6.25%)
    1 / 74 (1.35%)
    2 / 72 (2.78%)
    1 / 73 (1.37%)
         occurrences all number
    2
    6
    1
    0
    2
    3
    2
    6
    5
    5
    1
    2
    1
    Abdominal pain upper
         subjects affected / exposed
    1 / 73 (1.37%)
    5 / 72 (6.94%)
    3 / 73 (4.11%)
    0 / 75 (0.00%)
    1 / 66 (1.52%)
    4 / 64 (6.25%)
    6 / 65 (9.23%)
    3 / 66 (4.55%)
    1 / 64 (1.56%)
    3 / 64 (4.69%)
    1 / 74 (1.35%)
    1 / 72 (1.39%)
    1 / 73 (1.37%)
         occurrences all number
    1
    6
    4
    0
    1
    4
    7
    4
    1
    4
    1
    1
    1
    Abdominal pain
         subjects affected / exposed
    1 / 73 (1.37%)
    5 / 72 (6.94%)
    0 / 73 (0.00%)
    0 / 75 (0.00%)
    3 / 66 (4.55%)
    6 / 64 (9.38%)
    2 / 65 (3.08%)
    10 / 66 (15.15%)
    4 / 64 (6.25%)
    4 / 64 (6.25%)
    2 / 74 (2.70%)
    1 / 72 (1.39%)
    2 / 73 (2.74%)
         occurrences all number
    1
    7
    0
    0
    3
    7
    3
    14
    6
    8
    2
    1
    2
    Constipation
         subjects affected / exposed
    3 / 73 (4.11%)
    7 / 72 (9.72%)
    2 / 73 (2.74%)
    1 / 75 (1.33%)
    14 / 66 (21.21%)
    15 / 64 (23.44%)
    15 / 65 (23.08%)
    23 / 66 (34.85%)
    5 / 64 (7.81%)
    17 / 64 (26.56%)
    6 / 74 (8.11%)
    4 / 72 (5.56%)
    4 / 73 (5.48%)
         occurrences all number
    3
    7
    2
    1
    15
    17
    20
    31
    5
    19
    6
    4
    4
    Eructation
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
    0 / 75 (0.00%)
    3 / 66 (4.55%)
    0 / 64 (0.00%)
    2 / 65 (3.08%)
    4 / 66 (6.06%)
    0 / 64 (0.00%)
    5 / 64 (7.81%)
    0 / 74 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    0
    0
    0
    0
    4
    0
    3
    9
    0
    11
    0
    0
    0
    Dyspepsia
         subjects affected / exposed
    4 / 73 (5.48%)
    2 / 72 (2.78%)
    3 / 73 (4.11%)
    1 / 75 (1.33%)
    6 / 66 (9.09%)
    4 / 64 (6.25%)
    6 / 65 (9.23%)
    9 / 66 (13.64%)
    2 / 64 (3.13%)
    4 / 64 (6.25%)
    3 / 74 (4.05%)
    4 / 72 (5.56%)
    2 / 73 (2.74%)
         occurrences all number
    5
    2
    3
    1
    6
    5
    7
    13
    2
    5
    3
    4
    2
    Diarrhoea
         subjects affected / exposed
    8 / 73 (10.96%)
    9 / 72 (12.50%)
    8 / 73 (10.96%)
    1 / 75 (1.33%)
    10 / 66 (15.15%)
    10 / 64 (15.63%)
    16 / 65 (24.62%)
    17 / 66 (25.76%)
    12 / 64 (18.75%)
    17 / 64 (26.56%)
    8 / 74 (10.81%)
    4 / 72 (5.56%)
    6 / 73 (8.22%)
         occurrences all number
    8
    9
    9
    1
    15
    13
    23
    36
    17
    33
    10
    4
    7
    Gastrooesophageal reflux disease
         subjects affected / exposed
    3 / 73 (4.11%)
    2 / 72 (2.78%)
    0 / 73 (0.00%)
    0 / 75 (0.00%)
    10 / 66 (15.15%)
    6 / 64 (9.38%)
    5 / 65 (7.69%)
    13 / 66 (19.70%)
    1 / 64 (1.56%)
    6 / 64 (9.38%)
    3 / 74 (4.05%)
    4 / 72 (5.56%)
    1 / 73 (1.37%)
         occurrences all number
    3
    2
    0
    0
    15
    7
    5
    13
    1
    7
    3
    4
    1
    Nausea
         subjects affected / exposed
    21 / 73 (28.77%)
    17 / 72 (23.61%)
    11 / 73 (15.07%)
    3 / 75 (4.00%)
    34 / 66 (51.52%)
    30 / 64 (46.88%)
    38 / 65 (58.46%)
    40 / 66 (60.61%)
    8 / 64 (12.50%)
    32 / 64 (50.00%)
    19 / 74 (25.68%)
    14 / 72 (19.44%)
    10 / 73 (13.70%)
         occurrences all number
    31
    21
    14
    4
    51
    41
    56
    84
    9
    49
    22
    17
    11
    Vomiting
         subjects affected / exposed
    11 / 73 (15.07%)
    6 / 72 (8.33%)
    1 / 73 (1.37%)
    1 / 75 (1.33%)
    7 / 66 (10.61%)
    10 / 64 (15.63%)
    21 / 65 (32.31%)
    19 / 66 (28.79%)
    1 / 64 (1.56%)
    22 / 64 (34.38%)
    11 / 74 (14.86%)
    6 / 72 (8.33%)
    6 / 73 (8.22%)
         occurrences all number
    14
    8
    1
    1
    8
    13
    41
    30
    1
    38
    16
    11
    8
    Flatulence
         subjects affected / exposed
    1 / 73 (1.37%)
    1 / 72 (1.39%)
    0 / 73 (0.00%)
    1 / 75 (1.33%)
    1 / 66 (1.52%)
    1 / 64 (1.56%)
    1 / 65 (1.54%)
    3 / 66 (4.55%)
    2 / 64 (3.13%)
    4 / 64 (6.25%)
    4 / 74 (5.41%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    1
    1
    0
    1
    5
    1
    1
    3
    2
    10
    4
    0
    0
    Abdominal discomfort
         subjects affected / exposed
    1 / 73 (1.37%)
    1 / 72 (1.39%)
    0 / 73 (0.00%)
    0 / 75 (0.00%)
    3 / 66 (4.55%)
    1 / 64 (1.56%)
    3 / 65 (4.62%)
    2 / 66 (3.03%)
    0 / 64 (0.00%)
    3 / 64 (4.69%)
    6 / 74 (8.11%)
    5 / 72 (6.94%)
    1 / 73 (1.37%)
         occurrences all number
    1
    1
    0
    0
    3
    2
    3
    4
    0
    3
    7
    5
    1
    Dry mouth
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
    0 / 75 (0.00%)
    0 / 66 (0.00%)
    0 / 64 (0.00%)
    2 / 65 (3.08%)
    1 / 66 (1.52%)
    0 / 64 (0.00%)
    1 / 64 (1.56%)
    0 / 74 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    2
    1
    0
    1
    0
    0
    0
    Gastritis
         subjects affected / exposed
    1 / 73 (1.37%)
    1 / 72 (1.39%)
    0 / 73 (0.00%)
    0 / 75 (0.00%)
    0 / 66 (0.00%)
    0 / 64 (0.00%)
    0 / 65 (0.00%)
    0 / 66 (0.00%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    3 / 74 (4.05%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    3
    0
    0
    Hepatobiliary disorders
    Hepatic function abnormal
         subjects affected / exposed
    1 / 73 (1.37%)
    3 / 72 (4.17%)
    0 / 73 (0.00%)
    0 / 75 (0.00%)
    0 / 66 (0.00%)
    0 / 64 (0.00%)
    0 / 65 (0.00%)
    0 / 66 (0.00%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    4 / 74 (5.41%)
    2 / 72 (2.78%)
    0 / 73 (0.00%)
         occurrences all number
    1
    3
    0
    0
    0
    0
    0
    0
    0
    0
    4
    2
    0
    Cholelithiasis
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
    0 / 75 (0.00%)
    0 / 66 (0.00%)
    0 / 64 (0.00%)
    2 / 65 (3.08%)
    0 / 66 (0.00%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 74 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
    2 / 75 (2.67%)
    0 / 66 (0.00%)
    0 / 64 (0.00%)
    0 / 65 (0.00%)
    0 / 66 (0.00%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 74 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Rash
         subjects affected / exposed
    0 / 73 (0.00%)
    1 / 72 (1.39%)
    0 / 73 (0.00%)
    0 / 75 (0.00%)
    1 / 66 (1.52%)
    2 / 64 (3.13%)
    0 / 65 (0.00%)
    2 / 66 (3.03%)
    1 / 64 (1.56%)
    1 / 64 (1.56%)
    1 / 74 (1.35%)
    0 / 72 (0.00%)
    2 / 73 (2.74%)
         occurrences all number
    0
    1
    0
    0
    1
    3
    0
    3
    1
    1
    1
    0
    2
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 73 (0.00%)
    3 / 72 (4.17%)
    0 / 73 (0.00%)
    0 / 75 (0.00%)
    0 / 66 (0.00%)
    0 / 64 (0.00%)
    0 / 65 (0.00%)
    0 / 66 (0.00%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 74 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    0
    3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Microalbuminuria
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 72 (0.00%)
    2 / 73 (2.74%)
    0 / 75 (0.00%)
    0 / 66 (0.00%)
    0 / 64 (0.00%)
    0 / 65 (0.00%)
    0 / 66 (0.00%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 74 (0.00%)
    0 / 72 (0.00%)
    1 / 73 (1.37%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Haematuria
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
    0 / 75 (0.00%)
    0 / 66 (0.00%)
    0 / 64 (0.00%)
    0 / 65 (0.00%)
    0 / 66 (0.00%)
    2 / 64 (3.13%)
    0 / 64 (0.00%)
    0 / 74 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 73 (1.37%)
    1 / 72 (1.39%)
    2 / 73 (2.74%)
    1 / 75 (1.33%)
    2 / 66 (3.03%)
    1 / 64 (1.56%)
    3 / 65 (4.62%)
    4 / 66 (6.06%)
    2 / 64 (3.13%)
    3 / 64 (4.69%)
    1 / 74 (1.35%)
    0 / 72 (0.00%)
    1 / 73 (1.37%)
         occurrences all number
    1
    1
    2
    1
    2
    1
    3
    4
    2
    3
    1
    0
    1
    Muscle spasms
         subjects affected / exposed
    1 / 73 (1.37%)
    0 / 72 (0.00%)
    2 / 73 (2.74%)
    0 / 75 (0.00%)
    0 / 66 (0.00%)
    0 / 64 (0.00%)
    0 / 65 (0.00%)
    0 / 66 (0.00%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 74 (0.00%)
    0 / 72 (0.00%)
    2 / 73 (2.74%)
         occurrences all number
    1
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
    0 / 75 (0.00%)
    0 / 66 (0.00%)
    0 / 64 (0.00%)
    0 / 65 (0.00%)
    0 / 66 (0.00%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    2 / 74 (2.70%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    Pain in extremity
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
    0 / 75 (0.00%)
    1 / 66 (1.52%)
    1 / 64 (1.56%)
    1 / 65 (1.54%)
    3 / 66 (4.55%)
    1 / 64 (1.56%)
    0 / 64 (0.00%)
    0 / 74 (0.00%)
    2 / 72 (2.78%)
    1 / 73 (1.37%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    1
    3
    1
    0
    0
    3
    1
    Myalgia
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
    0 / 75 (0.00%)
    0 / 66 (0.00%)
    2 / 64 (3.13%)
    0 / 65 (0.00%)
    0 / 66 (0.00%)
    1 / 64 (1.56%)
    0 / 64 (0.00%)
    0 / 74 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    2
    0
    0
    1
    0
    0
    0
    0
    Arthralgia
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
    0 / 75 (0.00%)
    2 / 66 (3.03%)
    0 / 64 (0.00%)
    2 / 65 (3.08%)
    3 / 66 (4.55%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 74 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    2
    3
    0
    0
    0
    0
    0
    Osteoarthritis
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
    0 / 75 (0.00%)
    0 / 66 (0.00%)
    0 / 64 (0.00%)
    0 / 65 (0.00%)
    0 / 66 (0.00%)
    2 / 64 (3.13%)
    0 / 64 (0.00%)
    0 / 74 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    Infections and infestations
    COVID-19
         subjects affected / exposed
    1 / 73 (1.37%)
    0 / 72 (0.00%)
    2 / 73 (2.74%)
    0 / 75 (0.00%)
    3 / 66 (4.55%)
    2 / 64 (3.13%)
    1 / 65 (1.54%)
    2 / 66 (3.03%)
    5 / 64 (7.81%)
    5 / 64 (7.81%)
    2 / 74 (2.70%)
    1 / 72 (1.39%)
    0 / 73 (0.00%)
         occurrences all number
    1
    0
    2
    0
    4
    2
    1
    2
    5
    5
    2
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    2 / 73 (2.74%)
    3 / 72 (4.17%)
    0 / 73 (0.00%)
    1 / 75 (1.33%)
    5 / 66 (7.58%)
    2 / 64 (3.13%)
    4 / 65 (6.15%)
    2 / 66 (3.03%)
    0 / 64 (0.00%)
    4 / 64 (6.25%)
    2 / 74 (2.70%)
    1 / 72 (1.39%)
    0 / 73 (0.00%)
         occurrences all number
    2
    3
    0
    1
    6
    2
    5
    2
    0
    5
    2
    1
    0
    Urinary tract infection
         subjects affected / exposed
    1 / 73 (1.37%)
    4 / 72 (5.56%)
    1 / 73 (1.37%)
    1 / 75 (1.33%)
    2 / 66 (3.03%)
    2 / 64 (3.13%)
    6 / 65 (9.23%)
    5 / 66 (7.58%)
    2 / 64 (3.13%)
    3 / 64 (4.69%)
    6 / 74 (8.11%)
    0 / 72 (0.00%)
    4 / 73 (5.48%)
         occurrences all number
    2
    5
    1
    2
    2
    2
    7
    5
    3
    5
    7
    0
    5
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 73 (0.00%)
    1 / 72 (1.39%)
    1 / 73 (1.37%)
    2 / 75 (2.67%)
    2 / 66 (3.03%)
    1 / 64 (1.56%)
    4 / 65 (6.15%)
    5 / 66 (7.58%)
    3 / 64 (4.69%)
    0 / 64 (0.00%)
    0 / 74 (0.00%)
    1 / 72 (1.39%)
    3 / 73 (4.11%)
         occurrences all number
    0
    1
    1
    2
    2
    1
    4
    5
    3
    0
    0
    1
    3
    Sinusitis
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
    0 / 75 (0.00%)
    0 / 66 (0.00%)
    3 / 64 (4.69%)
    1 / 65 (1.54%)
    2 / 66 (3.03%)
    4 / 64 (6.25%)
    0 / 64 (0.00%)
    0 / 74 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    3
    1
    2
    4
    0
    0
    0
    0
    Bronchitis
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 72 (0.00%)
    1 / 73 (1.37%)
    1 / 75 (1.33%)
    4 / 66 (6.06%)
    1 / 64 (1.56%)
    3 / 65 (4.62%)
    0 / 66 (0.00%)
    1 / 64 (1.56%)
    0 / 64 (0.00%)
    2 / 74 (2.70%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    0
    0
    2
    1
    4
    1
    3
    0
    1
    0
    2
    0
    0
    Cellulitis
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
    0 / 75 (0.00%)
    0 / 66 (0.00%)
    0 / 64 (0.00%)
    0 / 65 (0.00%)
    0 / 66 (0.00%)
    2 / 64 (3.13%)
    0 / 64 (0.00%)
    0 / 74 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    Cystitis
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
    0 / 75 (0.00%)
    0 / 66 (0.00%)
    0 / 64 (0.00%)
    0 / 65 (0.00%)
    2 / 66 (3.03%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 74 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Gastroenteritis viral
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
    0 / 75 (0.00%)
    0 / 66 (0.00%)
    2 / 64 (3.13%)
    0 / 65 (0.00%)
    2 / 66 (3.03%)
    0 / 64 (0.00%)
    1 / 64 (1.56%)
    0 / 74 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    2
    0
    2
    0
    1
    0
    0
    0
    Gastroenteritis
         subjects affected / exposed
    1 / 73 (1.37%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
    0 / 75 (0.00%)
    1 / 66 (1.52%)
    1 / 64 (1.56%)
    3 / 65 (4.62%)
    2 / 66 (3.03%)
    2 / 64 (3.13%)
    1 / 64 (1.56%)
    0 / 74 (0.00%)
    0 / 72 (0.00%)
    2 / 73 (2.74%)
         occurrences all number
    1
    0
    0
    0
    1
    1
    4
    2
    2
    2
    0
    0
    2
    Ear infection
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
    0 / 75 (0.00%)
    0 / 66 (0.00%)
    0 / 64 (0.00%)
    1 / 65 (1.54%)
    2 / 66 (3.03%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 74 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    2
    0
    0
    0
    0
    0
    Viral infection
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
    0 / 75 (0.00%)
    0 / 66 (0.00%)
    2 / 64 (3.13%)
    0 / 65 (0.00%)
    0 / 66 (0.00%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 74 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    3
    0
    0
    0
    0
    0
    0
    0
    Pharyngitis
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 72 (0.00%)
    1 / 73 (1.37%)
    2 / 75 (2.67%)
    0 / 66 (0.00%)
    0 / 64 (0.00%)
    0 / 65 (0.00%)
    0 / 66 (0.00%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 74 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    0
    0
    1
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    3 / 73 (4.11%)
    5 / 72 (6.94%)
    1 / 73 (1.37%)
    1 / 75 (1.33%)
    5 / 66 (7.58%)
    7 / 64 (10.94%)
    3 / 65 (4.62%)
    8 / 66 (12.12%)
    5 / 64 (7.81%)
    8 / 64 (12.50%)
    7 / 74 (9.46%)
    4 / 72 (5.56%)
    0 / 73 (0.00%)
         occurrences all number
    3
    5
    1
    1
    5
    7
    3
    9
    6
    12
    7
    4
    0
    Hyperglycaemia
         subjects affected / exposed
    1 / 73 (1.37%)
    1 / 72 (1.39%)
    1 / 73 (1.37%)
    6 / 75 (8.00%)
    0 / 66 (0.00%)
    0 / 64 (0.00%)
    0 / 65 (0.00%)
    0 / 66 (0.00%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    1 / 74 (1.35%)
    1 / 72 (1.39%)
    3 / 73 (4.11%)
         occurrences all number
    1
    1
    1
    6
    0
    0
    0
    0
    0
    0
    1
    1
    4
    Hypokalaemia
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
    0 / 75 (0.00%)
    0 / 66 (0.00%)
    0 / 64 (0.00%)
    0 / 65 (0.00%)
    0 / 66 (0.00%)
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 74 (0.00%)
    0 / 72 (0.00%)
    2 / 73 (2.74%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    1 participant in placebo (T2DM) arm with withdrawal reason as Death in treatment phase was also counted in follow-up with the reason for discontinuation as death since exact date of last dose was unknown.
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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