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    Clinical Trial Results:
    A 56-week, Multicenter, Double-blind, Placebo-controlled, Randomized Study to Evaluate the Efficacy and Safety of Efpeglenatide Once Weekly in Patients with Type 2 Diabetes Mellitus Inadequately Controlled with Diet and Exercise

    Summary
    EudraCT number
    		 2016-001857-42
    Trial protocol
    		 GB   DE   PL  
    Global end of trial date
    07 Sep 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Aug 2021
    First version publication date
    04 Aug 2021
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    EFC14822
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03353350
    WHO universal trial number (UTN)
    		 U1111-1182-1806
    Sponsors
    Sponsor organisation name
    Hanmi Pharmaceuticals Co., Ltd.
    Sponsor organisation address
    14 Wiryeseong daero, Songpa gu, Seoul, Korea, Republic of, 05545
    Public contact
    Clinical Director's Office, Hanmi Pharmaceutical Co., Ltd., 82 24100473, sujin.jung@hanmi.co.kr
    Scientific contact
    Clinical Director's Office, Hanmi Pharmaceutical Co., Ltd., 82 24100469, jdchoi@hanmi.co.kr
    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
    07 Mar 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    29 Jan 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Sep 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate the superiority of once weekly injection of efpeglenatide 2, 4, or 6 mg in comparison to placebo in HbA1c change from baseline to Week 30 in participants with T2DM inadequately controlled with diet and exercise.
    Protection of trial subjects
    The study was conducted in accordance with consensus ethics principles derived from international ethics guidelines, including the Declaration of Helsinki, and the ICH guidelines for GCP, all applicable laws, rules, and regulations. Informed consent was obtained prior to the conduct of any study related procedures. The participant ICF was modified according to local regulations and requirements. An IDMC reviewed and analyzed unblinded safety data throughout the study, as well as safety data from the other ongoing clinical studies conducted with efpeglenatide (a single IDMC for the whole efpeglenatide program). Several subject´s visits and on-site monitoring activities were impacted by the COVID-19 pandemic in all countries. Starting in March 2020, a Business Continuity Plan was implemented to closely monitor the situation and to be able to identify risks, better assess the impact and set up contingency plans as needed. The patient treatment and safety were not impacted. There were no patients with COVID-19 infection.
    Background therapy
    		 -
    Evidence for comparator
    		 No comparator
    Actual start date of recruitment
    05 Dec 2017
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 2 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 49
    Country: Number of subjects enrolled
    United Kingdom: 70
    Country: Number of subjects enrolled
    Germany: 7
    Country: Number of subjects enrolled
    Ukraine: 58
    Country: Number of subjects enrolled
    United States: 222
    Worldwide total number of subjects
    406
    EEA total number of subjects
    56
    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)
    271
    From 65 to 84 years
    134
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects who met all of the inclusion criteria and none of the exclusion criteria were enrolled into the study and were randomly assigned into 1 of 3 dose levels of efpeglenatide (2, 4, or 6 mg) or to placebo. Participants aged ≥18 years with T2DM, treated with diet and exercise, and with HbA1c between 7.0% and 10.0% (inclusive) were eligible.

    Pre-assignment
    Screening details
    		 Up to 3-week Screening Period (Week -3/-1, Visit 1-2). A total of 900 participants were screened, 406 participants with T2DM inadequately controlled with diet/exercise were randomly assigned to efpeglenatide or to matching placebo. 494 (54.9%) participants were screen failures.

    Period 1
    Period 1 title
    30-week Core Treatment Period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer
    Blinding implementation details
    During the double-blind treatment period, which included titration (baseline-Day 1, weeks 1-3 (visit 3-4), investigators and participants were blinded to the allocation of active or placebo treatment arms. Efpeglenatide and matching placebo formulation : 500 μL of a sterile, nonpyrogenic, clear, colorless solution in a 1 mL disposable PFS, SC injection once weekly on the same day of the week.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Efpeglenatide 2mg
    Arm description
    		 Through the the double-blind treatment period, participants were randomly assigned to Efpeglenatide 2 mg from Week 4 (Visit 5) until Week 30.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Efpeglenatide 2 mg
    Investigational medicinal product code
    Other name
    SAR439977, HM11260C
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    The IMP included efpeglenatide 2 mg for Subcutaneous (SC) injection during the 56 weeks of treatment.

    Arm title
    		 Efpeglenatide 4 mg
    Arm description
    		 Through the the double-blind treatment period, participants were randomly assigned to Efpeglenatide 4 mg from Week 4 (Visit 5) until Week 30.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Efpeglenatide 4 mg
    Investigational medicinal product code
    Other name
    SAR439977, HM11260C
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    The IMP included efpeglenatide 4 mg for Subcutaneous (SC) injection during the 56 weeks of treatment.

    Arm title
    		 Efpeglenatide 6 mg
    Arm description
    		 Through the the double-blind treatment period, participants were randomly assigned to Efpeglenatide 6 mg from Week 4 (Visit 5) until Week 30.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Efpeglenatide 6 mg
    Investigational medicinal product code
    Other name
    SAR439977, HM11260C
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    The IMP included efpeglenatide 6 mg for Subcutaneous (SC) injection during the 56 weeks of treatment.

    Arm title
    		 Placebo
    Arm description
    		 Through the the double-blind treatment period, participants were randomly assigned to Placebo from Week 4 (Visit 5) until Week 30.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    SAR439977, HM11260C
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Matching placebo (sterile, nonpyrogenic, clear, colorless solution in a 1 mL disposable PFS) for Subcutaneous (SC) injection during the 56 weeks of treatment.

    Number of subjects in period 1
    		Efpeglenatide 2mg Efpeglenatide 4 mg Efpeglenatide 6 mg Placebo
    Started
    100
    101
    103
    102
    Completed
    81
    77
    81
    80
    Not completed
    19
    24
    22
    22
         Consent withdrawn by subject
    12
    19
    19
    19
         Adverse event, non-fatal
    4
    2
    3
    -
         Other
    2
    2
    -
    2
         Protocol deviation
    1
    1
    -
    1
    Period 2
    Period 2 title
    26-week Treatment Extension Period
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer
    Blinding implementation details
    During the double-blind treatment period, which included titration (baseline-Day 1, weeks 1-3 (visit 3-4), investigators and participants were blinded to the allocation of active or placebo treatment arms. Efpeglenatide and matching placebo formulation : 500 μL of a sterile, nonpyrogenic, clear, colorless solution in a 1 mL disposable PFS, SC injection once weekly on the same day of the week.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Efpeglenatide 2mg
    Arm description
    		 From Week 4 (Visit 5) through the rest of the double-blind treatment period, participants remained on the randomly assigned Efpeglenatide 2 mg until the EOT at Week 56 (Visit 14).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Efpeglenatide 2 mg
    Investigational medicinal product code
    Other name
    SAR439977, HM11260C
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    The IMP included efpeglenatide 2 mg for Subcutaneous (SC) injection during the 56 weeks of treatment.

    Arm title
    		 Efpeglenatide 4 mg
    Arm description
    		 From Week 4 (Visit 5) through the rest of the double-blind treatment period, participants remained on the randomly assigned Efpeglenatide 4 mg until the EOT at Week 56 (Visit 14).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Efpeglenatide 4 mg
    Investigational medicinal product code
    Other name
    SAR439977, HM11260C
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    The IMP included efpeglenatide 4 mg for Subcutaneous (SC) injection during the 56 weeks of treatment.

    Arm title
    		 Efpeglenatide 6 mg
    Arm description
    		 From Week 4 (Visit 5) through the rest of the double-blind treatment period, participants remained on the randomly assigned Efpeglenatide 6 mg until the EOT at Week 56 (Visit 14).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Efpeglenatide 6 mg
    Investigational medicinal product code
    Other name
    SAR439977, HM11260C
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    The IMP included efpeglenatide 6 mg for Subcutaneous (SC) injection during the 56 weeks of treatment.

    Arm title
    		 Placebo
    Arm description
    		 From Week 4 (Visit 5) through the rest of the double-blind treatment period, participants remained on the randomly assigned Placebo until the EOT at Week 56 (Visit 14).
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    SAR439977, HM11260C
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Matching placebo (sterile, nonpyrogenic, clear, colorless solution in a 1 mL disposable PFS) for Subcutaneous (SC) injection during the 56 weeks of treatment.

    Number of subjects in period 2
    		Efpeglenatide 2mg Efpeglenatide 4 mg Efpeglenatide 6 mg Placebo
    Started
    81
    77
    81
    80
    Completed
    78
    73
    67
    75
    Not completed
    3
    4
    14
    5
         Consent withdrawn by subject
    3
    3
    12
    2
         Adverse event, non-fatal
    -
    -
    1
    1
         Other
    -
    1
    1
    -
         Protocol deviation
    -
    -
    -
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Efpeglenatide 2mg
    Reporting group description
    		 Through the the double-blind treatment period, participants were randomly assigned to Efpeglenatide 2 mg from Week 4 (Visit 5) until Week 30.

    Reporting group title
    Efpeglenatide 4 mg
    Reporting group description
    		 Through the the double-blind treatment period, participants were randomly assigned to Efpeglenatide 4 mg from Week 4 (Visit 5) until Week 30.

    Reporting group title
    Efpeglenatide 6 mg
    Reporting group description
    		 Through the the double-blind treatment period, participants were randomly assigned to Efpeglenatide 6 mg from Week 4 (Visit 5) until Week 30.

    Reporting group title
    Placebo
    Reporting group description
    		 Through the the double-blind treatment period, participants were randomly assigned to Placebo from Week 4 (Visit 5) until Week 30.

    Reporting group values
    		 Efpeglenatide 2mg Efpeglenatide 4 mg Efpeglenatide 6 mg Placebo Total
    Number of subjects
    		 100 101 103 102 406
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 67 74 65 65 271
        From 65-84 years
    		 33 27 38 36 134
        85 years and over
    		 0 0 0 1 1
    Age continuous
    Units: years
        median (full range (min-max))
    		 59 (33 to 79) 55 (27 to 82) 61 (32 to 80) 59 (30 to 86) -
    Gender categorical
    Units: Subjects
        Female
    		 45 49 42 51 187
        Male
    		 55 52 61 51 219
    Subject analysis sets

    Subject analysis set title
    Randomized population
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The randomized population included any participant who had been allocated to a randomized treatment by IRT regardless of whether the treatment kit was used and with a signed informed consent.

    Subject analysis set title
    Efficacy population
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The Efficacy (ITT) population was defined as all randomized participants, irrespective of compliance with the study protocol and procedures analyzed, according to the treatment group allocated by randomization.

    Subject analysis set title
    Safety population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The safety population was defined as randomized population who actually received at least 1 dose or part of a dose of the IMP, analyzed according to the treatment actually received.

    Subject analysis sets values
    		 Randomized population Efficacy population Safety population
    Number of subjects
    406
    406
    406
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    271
    271
    271
        From 65-84 years
    134
    134
    134
        85 years and over
    1
    1
    1
    Age continuous
    Units: years
        median (full range (min-max))
    59 (27 to 86)
    59 (27 to 86)
    59 (27 to 86)
    Gender categorical
    Units: Subjects
        Female
    187
    187
    187
        Male
    219
    219
    219

    End points

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    End points reporting groups
    Reporting group title
    Efpeglenatide 2mg
    Reporting group description
    		 Through the the double-blind treatment period, participants were randomly assigned to Efpeglenatide 2 mg from Week 4 (Visit 5) until Week 30.

    Reporting group title
    Efpeglenatide 4 mg
    Reporting group description
    		 Through the the double-blind treatment period, participants were randomly assigned to Efpeglenatide 4 mg from Week 4 (Visit 5) until Week 30.

    Reporting group title
    Efpeglenatide 6 mg
    Reporting group description
    		 Through the the double-blind treatment period, participants were randomly assigned to Efpeglenatide 6 mg from Week 4 (Visit 5) until Week 30.

    Reporting group title
    Placebo
    Reporting group description
    		 Through the the double-blind treatment period, participants were randomly assigned to Placebo from Week 4 (Visit 5) until Week 30.
    Reporting group title
    Efpeglenatide 2mg
    Reporting group description
    		 From Week 4 (Visit 5) through the rest of the double-blind treatment period, participants remained on the randomly assigned Efpeglenatide 2 mg until the EOT at Week 56 (Visit 14).

    Reporting group title
    Efpeglenatide 4 mg
    Reporting group description
    		 From Week 4 (Visit 5) through the rest of the double-blind treatment period, participants remained on the randomly assigned Efpeglenatide 4 mg until the EOT at Week 56 (Visit 14).

    Reporting group title
    Efpeglenatide 6 mg
    Reporting group description
    		 From Week 4 (Visit 5) through the rest of the double-blind treatment period, participants remained on the randomly assigned Efpeglenatide 6 mg until the EOT at Week 56 (Visit 14).

    Reporting group title
    Placebo
    Reporting group description
    		 From Week 4 (Visit 5) through the rest of the double-blind treatment period, participants remained on the randomly assigned Placebo until the EOT at Week 56 (Visit 14).

    Subject analysis set title
    Randomized population
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The randomized population included any participant who had been allocated to a randomized treatment by IRT regardless of whether the treatment kit was used and with a signed informed consent.

    Subject analysis set title
    Efficacy population
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The Efficacy (ITT) population was defined as all randomized participants, irrespective of compliance with the study protocol and procedures analyzed, according to the treatment group allocated by randomization.

    Subject analysis set title
    Safety population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The safety population was defined as randomized population who actually received at least 1 dose or part of a dose of the IMP, analyzed according to the treatment actually received.

    Primary: Analysis of HbA1c (%) change from Baseline to Week 30

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    End point title
    		 Analysis of HbA1c (%) change from Baseline to Week 30
    End point description
    The 3 efpeglenatide doses were tested in the order of 6 mg, 4 mg, and 2 mg for superiority to placebo. The primary objective of the study was met as demonstrated by the statistical superiority of efpeglenatide over placebo in all 3 dose groups.
    End point type
    Primary
    End point timeframe
    From Baseline to Week 30
    End point values
    		 Efpeglenatide 2mg Efpeglenatide 4 mg Efpeglenatide 6 mg Placebo
    Number of subjects analysed
    100
    101
    103
    102
    Units: percent
    arithmetic mean (standard deviation)
        Baseline
    8.08 ± 0.86
    8.09 ± 0.93
    8.05 ± 0.95
    7.97 ± 0.89
        Week 30
    6.88 ± 1.03
    6.61 ± 0.80
    6.44 ± 0.67
    7.50 ± 1.03
        Change from Baseline to Week 30
    -1.14 ± 0.96
    -1.48 ± 1.01
    -1.59 ± 1.04
    -0.46 ± 1.16
    Statistical analysis title
    		 Statistical Analysis Plan - 2 mg vs Placebo
    Statistical analysis description
    The primary efficacy endpoint (change from baseline to Week 30 in HbA1c) was analyzed using an ANCOVA model with missing values imputed based upon retrieved dropouts in 2 separate parts. Descriptive statistics were based on observed data.
    Comparison groups
    Efpeglenatide 2mg v Placebo
    Number of subjects included in analysis
    202
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 = 0.0054
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean (SE)
    Point estimate
    -0.51
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.86
         upper limit
    		 -0.15
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.18
    Notes
    [1] - LS mean changes from baseline in HbA1c: -1.06% in the efpeglenatide 2 mg The LS mean differences were statistically significant for each efpeglenatide dose group versus placebo: -0.51% (95% CI: -0.86% to -0.15%; p=0.0054) in the efpeglenatide 2 mg
    Statistical analysis title
    		 Statistical Analysis Plan - 4 mg vs Placebo
    Statistical analysis description
    The primary efficacy endpoint (change from baseline to Week 30 in HbA1c) was analyzed using an ANCOVA model with missing values imputed based upon retrieved dropouts in 2 separate parts. Descriptive statistics were based on observed data.
    Comparison groups
    Efpeglenatide 4 mg v Placebo
    Number of subjects included in analysis
    203
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [2]
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean (SE)
    Point estimate
    -0.83
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.17
         upper limit
    		 -0.49
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.17
    Notes
    [2] - LS mean changes from baseline in HbA1c: -1.39% in the efpeglenatide 4 mg group The LS mean differences were statistically significant for each efpeglenatide dose group versus placebo: -0.83% (95% CI: -1.17% to -0.49%; p<0.0001) in the efpeglenatide 4 mg
    Statistical analysis title
    		 Statistical Analysis Plan - 6 mg vs Placebo
    Statistical analysis description
    The primary efficacy endpoint (change from baseline to Week 30 in HbA1c) was analyzed using an ANCOVA model with missing values imputed based upon retrieved dropouts in 2 separate parts. Descriptive statistics were based on observed data.
    Comparison groups
    Placebo v Efpeglenatide 6 mg
    Number of subjects included in analysis
    205
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [3]
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean (SE)
    Point estimate
    -1.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.35
         upper limit
    		 -0.72
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.16
    Notes
    [3] - LS mean changes from baseline in HbA1c: -1.59% in the efpeglenatide 6 mg The LS mean differences were statistically significant for each efpeglenatide dose group versus placebo: -1.04% (95% CI: -1.35% to -0.72%; p<0.0001) in the efpeglenatide 6 mg

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Treatment emergent adverse events (TEAEs) have been measured during Whole On-treatment Period. It is defined as the time from the first injection of the IMP up to 30 days (7 days for hypoglycemia) after the last injection of the IMP.
    Adverse event reporting additional description
    Efpeglenatide was generally well-tolerated with an acceptable safety profile in line with other GLP-1 RA class in general.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.0
    Reporting groups
    Reporting group title
    Efpeglenatide 2 mg
    Reporting group description
    		 From Week 4 (Visit 5) through the rest of the double-blind treatment period, participants remained on the randomly assigned Efpeglenatide 2 mg until the EOT at Week 56 (Visit 14).

    Reporting group title
    Efpeglenatide 4 mg
    Reporting group description
    		 From Week 4 (Visit 5) through the rest of the double-blind treatment period, participants remained on the randomly assigned Efpeglenatide 4 mg until the EOT at Week 56 (Visit 14).

    Reporting group title
    Efpeglenatide 6 mg
    Reporting group description
    		 From Week 4 (Visit 5) through the rest of the double-blind treatment period, participants remained on the randomly assigned Efpeglenatide 6 mg until the EOT at Week 56 (Visit 14).

    Reporting group title
    Placebo
    Reporting group description
    		 From Week 4 (Visit 5) through the rest of the double-blind treatment period, participants remained on the randomly assigned Placebo until the EOT at Week 56 (Visit 14).

    Serious adverse events
    		 Efpeglenatide 2 mg Efpeglenatide 4 mg Efpeglenatide 6 mg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    11 / 102 (10.78%)
    6 / 103 (5.83%)
    6 / 99 (6.06%)
    9 / 102 (8.82%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast cancer metastatic
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 103 (0.00%)
    1 / 99 (1.01%)
    0 / 102 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Laryngeal cancer
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 103 (0.00%)
    1 / 99 (1.01%)
    0 / 102 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Benign ovarian tumour
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 103 (0.00%)
    0 / 99 (0.00%)
    0 / 102 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Malignant melanoma
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 103 (0.00%)
    0 / 99 (0.00%)
    0 / 102 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neuroendocrine carcinoma
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 103 (0.00%)
    0 / 99 (0.00%)
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Prostate cancer
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 103 (0.97%)
    0 / 99 (0.00%)
    0 / 102 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Foreign body in respiratory tract
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 103 (0.00%)
    0 / 99 (0.00%)
    0 / 102 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Heat stroke
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 103 (0.97%)
    0 / 99 (0.00%)
    0 / 102 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumoconiosis
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 103 (0.00%)
    0 / 99 (0.00%)
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Ventricular tachycardia
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 103 (0.00%)
    1 / 99 (1.01%)
    0 / 102 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute myocardial infarction
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 103 (0.00%)
    0 / 99 (0.00%)
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Angina unstable
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 103 (0.00%)
    0 / 99 (0.00%)
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 103 (0.00%)
    0 / 99 (0.00%)
    0 / 102 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 103 (0.00%)
    0 / 99 (0.00%)
    0 / 102 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure congestive
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 103 (0.00%)
    0 / 99 (0.00%)
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 103 (0.00%)
    0 / 99 (0.00%)
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coronary artery stenosis
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 103 (0.00%)
    0 / 99 (0.00%)
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 103 (0.00%)
    0 / 99 (0.00%)
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Vertebral artery stenosis
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 103 (0.00%)
    1 / 99 (1.01%)
    0 / 102 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebral artery stenosis
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 103 (0.97%)
    0 / 99 (0.00%)
    0 / 102 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 103 (0.00%)
    0 / 99 (0.00%)
    0 / 102 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 103 (0.97%)
    0 / 99 (0.00%)
    0 / 102 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 103 (0.00%)
    0 / 99 (0.00%)
    0 / 102 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 103 (0.00%)
    0 / 99 (0.00%)
    0 / 102 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Benign prostatic hyperplasia
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 103 (0.00%)
    0 / 99 (0.00%)
    0 / 102 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 103 (0.00%)
    0 / 99 (0.00%)
    0 / 102 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Panic attack
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 103 (0.00%)
    0 / 99 (0.00%)
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Stress
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 103 (0.97%)
    0 / 99 (0.00%)
    0 / 102 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal colic
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 103 (0.00%)
    0 / 99 (0.00%)
    0 / 102 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ureterolithiasis
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 103 (0.97%)
    0 / 99 (0.00%)
    0 / 102 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Cystitis
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 103 (0.00%)
    1 / 99 (1.01%)
    0 / 102 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Epiglottitis
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 103 (0.00%)
    1 / 99 (1.01%)
    0 / 102 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 103 (0.00%)
    0 / 99 (0.00%)
    0 / 102 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Meningitis viral
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 103 (0.00%)
    0 / 99 (0.00%)
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 103 (0.97%)
    0 / 99 (0.00%)
    0 / 102 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 103 (0.97%)
    0 / 99 (0.00%)
    0 / 102 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 103 (0.97%)
    0 / 99 (0.00%)
    0 / 102 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hypokalaemia
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 103 (0.00%)
    0 / 99 (0.00%)
    0 / 102 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Efpeglenatide 2 mg Efpeglenatide 4 mg Efpeglenatide 6 mg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    80 / 102 (78.43%)
    79 / 103 (76.70%)
    83 / 99 (83.84%)
    79 / 102 (77.45%)
    Investigations
    Lipase increased
         subjects affected / exposed
    8 / 102 (7.84%)
    5 / 103 (4.85%)
    5 / 99 (5.05%)
    2 / 102 (1.96%)
         occurrences all number
    8
    5
    5
    2
    Weight decreased
         subjects affected / exposed
    2 / 102 (1.96%)
    2 / 103 (1.94%)
    5 / 99 (5.05%)
    0 / 102 (0.00%)
         occurrences all number
    2
    2
    5
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    8 / 102 (7.84%)
    3 / 103 (2.91%)
    6 / 99 (6.06%)
    4 / 102 (3.92%)
         occurrences all number
    8
    3
    6
    4
    Nervous system disorders
    Headache
         subjects affected / exposed
    6 / 102 (5.88%)
    10 / 103 (9.71%)
    15 / 99 (15.15%)
    7 / 102 (6.86%)
         occurrences all number
    6
    10
    15
    7
    Dizziness
         subjects affected / exposed
    2 / 102 (1.96%)
    10 / 103 (9.71%)
    6 / 99 (6.06%)
    6 / 102 (5.88%)
         occurrences all number
    2
    10
    6
    6
    General disorders and administration site conditions
    Injection site pain
         subjects affected / exposed
    9 / 102 (8.82%)
    11 / 103 (10.68%)
    11 / 99 (11.11%)
    6 / 102 (5.88%)
         occurrences all number
    9
    11
    11
    6
    Fatigue
         subjects affected / exposed
    3 / 102 (2.94%)
    4 / 103 (3.88%)
    5 / 99 (5.05%)
    3 / 102 (2.94%)
         occurrences all number
    3
    4
    5
    3
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    9 / 102 (8.82%)
    17 / 103 (16.50%)
    25 / 99 (25.25%)
    9 / 102 (8.82%)
         occurrences all number
    9
    17
    25
    9
    Constipation
         subjects affected / exposed
    9 / 102 (8.82%)
    14 / 103 (13.59%)
    16 / 99 (16.16%)
    6 / 102 (5.88%)
         occurrences all number
    9
    14
    16
    6
    Gastrooesophageal reflux disease
         subjects affected / exposed
    7 / 102 (6.86%)
    6 / 103 (5.83%)
    4 / 99 (4.04%)
    0 / 102 (0.00%)
         occurrences all number
    7
    6
    4
    0
    Dyspepsia
         subjects affected / exposed
    5 / 102 (4.90%)
    7 / 103 (6.80%)
    12 / 99 (12.12%)
    2 / 102 (1.96%)
         occurrences all number
    5
    7
    12
    2
    Abdominal distension
         subjects affected / exposed
    4 / 102 (3.92%)
    5 / 103 (4.85%)
    8 / 99 (8.08%)
    2 / 102 (1.96%)
         occurrences all number
    4
    5
    8
    2
    Flatulence
         subjects affected / exposed
    0 / 102 (0.00%)
    2 / 103 (1.94%)
    7 / 99 (7.07%)
    1 / 102 (0.98%)
         occurrences all number
    0
    2
    7
    1
    Abdominal pain upper
         subjects affected / exposed
    6 / 102 (5.88%)
    2 / 103 (1.94%)
    2 / 99 (2.02%)
    2 / 102 (1.96%)
         occurrences all number
    6
    2
    2
    2
    Nausea
         subjects affected / exposed
    6 / 102 (5.88%)
    15 / 103 (14.56%)
    22 / 99 (22.22%)
    2 / 102 (1.96%)
         occurrences all number
    6
    15
    22
    2
    Vomiting
         subjects affected / exposed
    3 / 102 (2.94%)
    8 / 103 (7.77%)
    9 / 99 (9.09%)
    0 / 102 (0.00%)
         occurrences all number
    3
    8
    9
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 102 (0.98%)
    2 / 103 (1.94%)
    5 / 99 (5.05%)
    3 / 102 (2.94%)
         occurrences all number
    1
    2
    5
    3
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    4 / 102 (3.92%)
    1 / 103 (0.97%)
    1 / 99 (1.01%)
    7 / 102 (6.86%)
         occurrences all number
    4
    1
    1
    7
    Back pain
         subjects affected / exposed
    1 / 102 (0.98%)
    4 / 103 (3.88%)
    5 / 99 (5.05%)
    3 / 102 (2.94%)
         occurrences all number
    1
    4
    5
    3
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    10 / 102 (9.80%)
    7 / 103 (6.80%)
    11 / 99 (11.11%)
    8 / 102 (7.84%)
         occurrences all number
    10
    7
    1
    8
    Sinusitis
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 103 (0.97%)
    2 / 99 (2.02%)
    6 / 102 (5.88%)
         occurrences all number
    0
    1
    2
    6
    Upper respiratory tract infection
         subjects affected / exposed
    3 / 102 (2.94%)
    5 / 103 (4.85%)
    6 / 99 (6.06%)
    7 / 102 (6.86%)
         occurrences all number
    3
    5
    6
    7
    Viral upper respiratory tract infection
         subjects affected / exposed
    6 / 102 (5.88%)
    5 / 103 (4.85%)
    6 / 99 (6.06%)
    7 / 102 (6.86%)
         occurrences all number
    6
    5
    6
    7
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    2 / 102 (1.96%)
    11 / 103 (10.68%)
    8 / 99 (8.08%)
    2 / 102 (1.96%)
         occurrences all number
    2
    11
    8
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    16 Jan 2018
    • Updates to the following sections were made: statistical analysis and methods of unblinding. • Other sections added to the protocol, to update text with new available information, to align the procedures with those in other studies within the program and/or for better clarity: - Schedule of activities, exploratory endpoints and dosing instructions (for PK predose); - Benefit/Risk assessment; - Exclusion criteria; - Antidrug antibody measurements; - Committee Structure. • Inconsistencies, typographical, and spelling checks were also run throughout the document and corrected.
    27 Mar 2018
    The protocol was updated to clarify the contraception requirements for WOCBP.
    07 Jun 2018
    • The protocol was updated to add the rationale for the selected efpeglenatide doses and to add an appendix subsection related to acute kidney failure as a consequence of severe GI events and dehydration. Monthly home urine pregnancy tests were added. • In addition, sponsor used this opportunity to edit other sections of the protocol, to update text with new available information (including statistical analysis update), to align the procedures with those in other studies within the program and/or for better clarity. • Inconsistencies, typographical, and spelling errors throughout the document were also corrected.

    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.
    None reported
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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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