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    Clinical Trial Results:
    A Phase 2a, Randomized, Active-Comparator-Controlled, Open-Label Study to Evaluate the Efficacy and Safety of Efinopegdutide (MK-6024) in Individuals With Nonalcoholic Fatty Liver Disease

    Summary
    EudraCT number
    		 2020-005136-30
    Trial protocol
    		 FR   ES   PL   IT  
    Global end of trial date
    19 Oct 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 Oct 2023
    First version publication date
    26 Oct 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    6024-001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Merck Sharp and Dohme LLC
    Sponsor organisation address
    126 East Lincoln Avenue, P.O. Box 2000, Rahway, NJ, United States, 07065
    Public contact
    Clinical Trials Disclosure, Merck Sharp & Dohme LLC, ClinicalTrialsDisclosure@merck.com
    Scientific contact
    Clinical Trials Disclosure, Merck Sharp & Dohme LLC, ClinicalTrialsDisclosure@merck.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
    19 Oct 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    19 Oct 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Oct 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The principal goal of this study is to determine the efficacy of efinopegdutide in liver fat reduction in participants with NAFLD. The primary hypotheses are that efinopegdutide is superior to semaglutide, or that efinopegdutide is superior to semaglutide by at least 10% with respect to mean relative reduction from baseline in liver fat content (LFC) after 24 weeks.
    Protection of trial subjects
    This study was conducted in conformance with Good Clinical Practice standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    04 Aug 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Argentina: 17
    Country: Number of subjects enrolled
    Australia: 5
    Country: Number of subjects enrolled
    France: 2
    Country: Number of subjects enrolled
    Israel: 24
    Country: Number of subjects enrolled
    Italy: 3
    Country: Number of subjects enrolled
    Korea, Democratic People's Republic of: 6
    Country: Number of subjects enrolled
    Mexico: 17
    Country: Number of subjects enrolled
    New Zealand: 5
    Country: Number of subjects enrolled
    Poland: 5
    Country: Number of subjects enrolled
    Russian Federation: 6
    Country: Number of subjects enrolled
    Spain: 9
    Country: Number of subjects enrolled
    Taiwan: 8
    Country: Number of subjects enrolled
    Turkey: 5
    Country: Number of subjects enrolled
    Ukraine: 8
    Country: Number of subjects enrolled
    United States: 25
    Worldwide total number of subjects
    145
    EEA total number of subjects
    19
    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)
    132
    From 65 to 84 years
    13
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This study was conducted at 51 clinical sites in 16 countries.

    Pre-assignment
    Screening details
    		 Participant flow as per the database cutoff date of 19OCT2022.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Efinopegdutide
    Arm description
    		 Efinopegdutide 20 mg/mL administered by injection once weekly for 24 weeks in a dose-escalation regimen: 2.4 mg from day 1 to week 3, 5.0 mg from week 4 to 7, and 10.0 mg from week 8 to 24.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Efinopegdutide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    20 mg/mL

    Arm title
    		 Semaglutide
    Arm description
    		 Semaglutide 1.34 mg/mL administered by injection once weekly for 24 weeks in a dose-escalation regimen: 0.25 mg from day 1 to week 3, 0.5 mg from week 4 to 7, and 1.0 mg from week 8 to 24.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Semaglutide 1.34 mg/mL administered by injection once weekly for
    Investigational medicinal product code
    Other name
    Ozempic®
    Pharmaceutical forms
    Solution for infusion, Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    1.34 mg/mL

    Number of subjects in period 1
    		Efinopegdutide Semaglutide
    Started
    72
    73
    Completed
    64
    71
    Not completed
    8
    2
         Physician decision
    1
    -
         Consent withdrawn by subject
    6
    1
         Lost to follow-up
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Efinopegdutide
    Reporting group description
    		 Efinopegdutide 20 mg/mL administered by injection once weekly for 24 weeks in a dose-escalation regimen: 2.4 mg from day 1 to week 3, 5.0 mg from week 4 to 7, and 10.0 mg from week 8 to 24.

    Reporting group title
    Semaglutide
    Reporting group description
    		 Semaglutide 1.34 mg/mL administered by injection once weekly for 24 weeks in a dose-escalation regimen: 0.25 mg from day 1 to week 3, 0.5 mg from week 4 to 7, and 1.0 mg from week 8 to 24.

    Reporting group values
    		 Efinopegdutide Semaglutide Total
    Number of subjects
    		 72 73 145
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 68 64 132
        From 65-84 years
    		 4 9 13
        85 years and over
    		 0 0 0
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 48.0 ± 11.0 50.7 ± 10.9 -
    Sex: Female, Male
    Units: Participants
        Female
    		 39 41 80
        Male
    		 33 32 65
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 3 2 5
        Asian
    		 7 7 14
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 0 1 1
        White
    		 62 63 125
        More than one race
    		 0 0 0
        Unknown or Not Reported
    		 0 0 0
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 25 26 51
        Not Hispanic or Latino
    		 46 47 93
        Unknown or Not Reported
    		 1 0 1
    Body Mass Index (BMI)
    Units: Kg/M^2
        arithmetic mean (standard deviation)
    		 35.2 ± 5.7 33.5 ± 5.0 -
    Weight
    Units: kg
        arithmetic mean (standard deviation)
    		 100.2 ± 18.9 94.4 ± 18.9 -

    End points

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    End points reporting groups
    Reporting group title
    Efinopegdutide
    Reporting group description
    		 Efinopegdutide 20 mg/mL administered by injection once weekly for 24 weeks in a dose-escalation regimen: 2.4 mg from day 1 to week 3, 5.0 mg from week 4 to 7, and 10.0 mg from week 8 to 24.

    Reporting group title
    Semaglutide
    Reporting group description
    		 Semaglutide 1.34 mg/mL administered by injection once weekly for 24 weeks in a dose-escalation regimen: 0.25 mg from day 1 to week 3, 0.5 mg from week 4 to 7, and 1.0 mg from week 8 to 24.

    Primary: Mean Relative Reduction from Baseline in Liver Fat Content (LFC) Measured by Magnetic Resonance Imaging-Estimated Proton Density Fat Fraction (MRI-PDFF), Evaluated by Blinded Independent Central Review (BICR) after 24 weeks

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    End point title
    		 Mean Relative Reduction from Baseline in Liver Fat Content (LFC) Measured by Magnetic Resonance Imaging-Estimated Proton Density Fat Fraction (MRI-PDFF), Evaluated by Blinded Independent Central Review (BICR) after 24 weeks
    End point description
    LFC was measured with liver images taken by MRI-PDFF and analyzed by BICR. The analysis population consisted of all randomized participants who had received at least 1 injection (including only partial) of study intervention and had at least 1 assessment. The mean relative reduction from baseline in LFC after 24 weeks of treatment is presented.
    End point type
    Primary
    End point timeframe
    Baseline and up to ~24 Weeks
    End point values
    		 Efinopegdutide Semaglutide
    Number of subjects analysed
    72
    73
    Units: Percent Change
        least squares mean (confidence interval 90%)
    72.7 (66.8 to 78.7)
    42.3 (36.5 to 48.1)
    Statistical analysis title
    		 Difference in Least Squared Means
    Comparison groups
    Efinopegdutide v Semaglutide
    Number of subjects included in analysis
    145
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 Difference in least squared means
    Point estimate
    30.4
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 22.1
         upper limit
    		 38.7

    Primary: Number of Participants Who Experienced an Adverse Event (AE)

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    End point title
    		 Number of Participants Who Experienced an Adverse Event (AE)
    End point description
    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The analysis population consisted of all randomized participants who received at least 1 injection (including only partial) of study intervention. The number of participants who experienced an adverse event is presented.
    End point type
    Primary
    End point timeframe
    Up to ~29 weeks
    End point values
    		 Efinopegdutide Semaglutide
    Number of subjects analysed
    72
    73
    Units: Percentage of Participants
        number (not applicable)
    88.9
    72.6
    Statistical analysis title
    		 Difference (Efinopegdutide – Semaglutide) in %
    Comparison groups
    Efinopegdutide v Semaglutide
    Number of subjects included in analysis
    145
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 difference in percentage
    Point estimate
    16.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.5
         upper limit
    		 29.1

    Primary: Number of Participants Who Discontinued Study Intervention Due to an AE

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    End point title
    		 Number of Participants Who Discontinued Study Intervention Due to an AE
    End point description
    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The analysis population consisted of all randomized participants who received at least 1 injection (including only partial) of study intervention. The number of participants who discontinued study intervention due to adverse event is presented.
    End point type
    Primary
    End point timeframe
    Up to ~24 weeks
    End point values
    		 Efinopegdutide Semaglutide
    Number of subjects analysed
    72
    73
    Units: Percentage of Participants
        number (not applicable)
    5.6
    0
    Statistical analysis title
    		 Difference (Efinopegdutide – Semaglutide) in %
    Comparison groups
    Efinopegdutide v Semaglutide
    Number of subjects included in analysis
    145
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    5.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.4
         upper limit
    		 13.5

    Secondary: Mean Absolute Reduction from Baseline in LFC Measured by MRI-PDFF (evaluated by BICR) After 24 Weeks

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    End point title
    		 Mean Absolute Reduction from Baseline in LFC Measured by MRI-PDFF (evaluated by BICR) After 24 Weeks
    End point description
    LFC was measured by liver images taken by MRI-PDFF and analyzed by BICR. The analysis population included all randomized participants who had received at least 1 injection (including only partial) of study intervention and had at least 1 assessment. The mean absolute reduction from baseline in LFC after 24 weeks of treatment is presented.
    End point type
    Secondary
    End point timeframe
    Baseline and up to ~24 Weeks
    End point values
    		 Efinopegdutide Semaglutide
    Number of subjects analysed
    72
    73
    Units: Percent Change
        least squares mean (confidence interval 90%)
    14.9 (13.6 to 16.3)
    8.8 (7.5 to 10.1)
    Statistical analysis title
    		 Difference in least squared means
    Comparison groups
    Efinopegdutide v Semaglutide
    Number of subjects included in analysis
    145
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 Difference in least squared means
    Point estimate
    6.1
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 4.6
         upper limit
    		 7.7

    Secondary: Mean Percent Change from Baseline in Body Weight After 24 weeks

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    End point title
    		 Mean Percent Change from Baseline in Body Weight After 24 weeks
    End point description
    Body weight in kilograms was measured using a standardized, digital scale. The analysis population included all randomized participants who had received at least 1 injection (including only partial) of study intervention and had at least 1 assessment. The mean percent change from baseline in body weight after 24 weeks is presented.
    End point type
    Secondary
    End point timeframe
    Baseline and up to ~24 weeks
    End point values
    		 Efinopegdutide Semaglutide
    Number of subjects analysed
    72
    73
    Units: Percent Change
        least squares mean (confidence interval 90%)
    -8.5 (-9.5 to -7.5)
    -7.1 (-8.1 to -6.2)
    Statistical analysis title
    		 Difference in Least Squared Means
    Comparison groups
    Efinopegdutide v Semaglutide
    Number of subjects included in analysis
    145
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.085
    Method
    		 Mixed models analysis
    Parameter type
    		 Difference in Least Squared Means
    Point estimate
    -1.4
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -2.7
         upper limit
    		 -0.1

    Secondary: Mean Change from Baseline in Total Cholesterol After 24 Weeks

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    End point title
    		 Mean Change from Baseline in Total Cholesterol After 24 Weeks
    End point description
    Fasting blood samples were collected at baseline and after 24 weeks of treatment to assess mean change in total cholesterol. The analysis population included all randomized participants who had received at least 1 injection (including only partial) of study intervention and had at least 1 assessment. The mean change in total cholesterol is presented.
    End point type
    Secondary
    End point timeframe
    Baseline and up to ~24 weeks
    End point values
    		 Efinopegdutide Semaglutide
    Number of subjects analysed
    72
    73
    Units: Percent Change
        least squares mean (confidence interval 90%)
    -15.2 (-18.2 to -12.2)
    -8.0 (-11.0 to -5.0)
    Statistical analysis title
    		 Difference (Efinopegdutide – Semaglutide) in %
    Comparison groups
    Efinopegdutide v Semaglutide
    Number of subjects included in analysis
    145
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Difference in Least Squared Means
    Point estimate
    -7.2
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -11.2
         upper limit
    		 -3.1

    Secondary: Mean Change from Baseline in Non-High Density Lipoprotein-Cholesterol (non-HDL-C) After 24 Weeks

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    End point title
    		 Mean Change from Baseline in Non-High Density Lipoprotein-Cholesterol (non-HDL-C) After 24 Weeks
    End point description
    Fasting blood samples were collected at baseline and after 24 weeks of treatment to assess mean change in non-HDL-C. The analysis population included all randomized participants who had received at least 1 injection (including only partial) of study intervention and had at least 1 assessment. The mean change in non-HDL-C is presented.
    End point type
    Secondary
    End point timeframe
    Baseline and up to ~24 weeks
    End point values
    		 Efinopegdutide Semaglutide
    Number of subjects analysed
    72
    73
    Units: Percent Change
        least squares mean (confidence interval 90%)
    -16.8 (-20.5 to -13.0)
    -11.0 (-14.8 to -7.3)
    Statistical analysis title
    		 Difference (Efinopegdutide – Semaglutide) in %
    Comparison groups
    Efinopegdutide v Semaglutide
    Number of subjects included in analysis
    145
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Difference in least squared means
    Point estimate
    -5.7
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -10.9
         upper limit
    		 -0.6

    Secondary: Mean Change from Baseline in High Density Lipoprotein-Cholesterol (HDL-C) After 24 Weeks

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    End point title
    		 Mean Change from Baseline in High Density Lipoprotein-Cholesterol (HDL-C) After 24 Weeks
    End point description
    Fasting blood samples were collected at baseline and after 24 weeks of treatment to assess mean change in HDL-C. The analysis population included all randomized participants who had received at least 1 injection (including only partial) of study intervention and had at least 1 assessment. Mean change in HDL-C is presented.
    End point type
    Secondary
    End point timeframe
    Baseline and up to ~24 weeks
    End point values
    		 Efinopegdutide Semaglutide
    Number of subjects analysed
    72
    73
    Units: Percent Change
        least squares mean (confidence interval 90%)
    -8.1 (-11.2 to -5.1)
    3.6 (0.6 to 6.6)
    Statistical analysis title
    		 Difference (Efinopegdutide – Semaglutide) in %
    Comparison groups
    Efinopegdutide v Semaglutide
    Number of subjects included in analysis
    145
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Difference in least squared means
    Point estimate
    -11.7
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -15.8
         upper limit
    		 -7.7

    Secondary: Mean Change from Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) After 24 weeks

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    End point title
    		 Mean Change from Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) After 24 weeks
    End point description
    Fasting blood samples were collected at baseline and after 24 weeks of treatment to assess mean change in LDL-C. The analysis population included all randomized participants who had received at least 1 injection (including only partial) of study intervention and had at least 1 assessment. The mean change in LDL-C is presented.
    End point type
    Secondary
    End point timeframe
    Baseline and up to ~24 weeks
    End point values
    		 Efinopegdutide Semaglutide
    Number of subjects analysed
    72
    73
    Units: Percent Change
        least squares mean (confidence interval 90%)
    -13.0 (-17.4 to -8.6)
    -6.9 (-11.3 to -2.6)
    Statistical analysis title
    		 Difference (Efinopegdutide – Semaglutide) in %
    Comparison groups
    Efinopegdutide v Semaglutide
    Number of subjects included in analysis
    145
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Difference in least squared means
    Point estimate
    -6.1
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -12
         upper limit
    		 -0.1

    Secondary: Mean Change from Baseline in Triglycerides (TG) After 24 Weeks

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    End point title
    		 Mean Change from Baseline in Triglycerides (TG) After 24 Weeks
    End point description
    Fasting blood samples were collected at baseline and after 24 weeks of treatment to assess mean change in triglycerides. The analysis population included all randomized participants who had received at least 1 injection (including only partial) of study intervention and had at least 1 assessment. The mean change in triglycerides is presented.
    End point type
    Secondary
    End point timeframe
    Baseline and up to ~24 weeks
    End point values
    		 Efinopegdutide Semaglutide
    Number of subjects analysed
    72
    73
    Units: Percent Change
        least squares mean (confidence interval 90%)
    -30.9 (-35.6 to -25.8)
    -23.3 (-28.5 to -17.7)
    Statistical analysis title
    		 Difference (Efinopegdutide – Semaglutide) in %
    Comparison groups
    Efinopegdutide v Semaglutide
    Number of subjects included in analysis
    145
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Difference in least squared means
    Point estimate
    -7.6
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -14.3
         upper limit
    		 -0.9

    Secondary: Mean Change from Baseline in Apolipoprotein B (apoB) After 24 Weeks

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    End point title
    		 Mean Change from Baseline in Apolipoprotein B (apoB) After 24 Weeks
    End point description
    Fasting blood samples were collected at baseline and after 24 weeks of treatment to assess mean change in apoB. The analysis population included all randomized participants who had received at least 1 injection (including only partial) of study intervention and had at least 1 assessment. The mean change in apoB is presented.
    End point type
    Secondary
    End point timeframe
    Baseline and up to ~24 weeks
    End point values
    		 Efinopegdutide Semaglutide
    Number of subjects analysed
    72
    73
    Units: Percent Change
        least squares mean (confidence interval 90%)
    -14.7 (-18.2 to -11.1)
    -9.2 (-12.8 to -5.7)
    Statistical analysis title
    		 Difference (Efinopegdutide – Semaglutide) in %
    Comparison groups
    Efinopegdutide v Semaglutide
    Number of subjects included in analysis
    145
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Difference in least squared means
    Point estimate
    -5.4
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -10.4
         upper limit
    		 -0.4

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Death and adverse events up to ~29 weeks
    Adverse event reporting additional description
    Every participant is counted a single time for each applicable non-serious adverse event. A system organ class appears on this report only if one or more specific non-serious adverse events in that system organ class occurred during the study period.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.1
    Reporting groups
    Reporting group title
    Semaglutide
    Reporting group description
    		 Semaglutide 1.34 mg/mL administered by injection once weekly for 24 weeks in a dose-escalation regimen: 0.25 mg from day 1 to week 3, 0.5 mg from week 4 to 7, and 1.0 mg from week 8 to 24.

    Reporting group title
    Efinopegdutide
    Reporting group description
    		 Efinopegdutide 20 mg/mL administered by injection once weekly for 24 weeks in a dose-escalation regimen: 2.4 mg from day 1 to week 3, 5.0 mg from week 4 to 7, and 10.0 mg from week 8 to 24.

    Serious adverse events
    		 Semaglutide Efinopegdutide
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 73 (1.37%)
    1 / 72 (1.39%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Renal and urinary disorders
    Calculus urinary
         subjects affected / exposed
    0 / 73 (0.00%)
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Spinal osteoarthritis
         subjects affected / exposed
    1 / 73 (1.37%)
    0 / 72 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Semaglutide Efinopegdutide
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    44 / 73 (60.27%)
    57 / 72 (79.17%)
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 73 (0.00%)
    4 / 72 (5.56%)
         occurrences all number
    0
    4
    Lipase increased
         subjects affected / exposed
    3 / 73 (4.11%)
    4 / 72 (5.56%)
         occurrences all number
    3
    5
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    2 / 73 (2.74%)
    4 / 72 (5.56%)
         occurrences all number
    2
    7
    Headache
         subjects affected / exposed
    5 / 73 (6.85%)
    5 / 72 (6.94%)
         occurrences all number
    8
    5
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    6 / 73 (8.22%)
    1 / 72 (1.39%)
         occurrences all number
    6
    1
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    3 / 73 (4.11%)
    4 / 72 (5.56%)
         occurrences all number
    4
    4
    Abdominal pain
         subjects affected / exposed
    2 / 73 (2.74%)
    9 / 72 (12.50%)
         occurrences all number
    4
    15
    Abdominal pain upper
         subjects affected / exposed
    1 / 73 (1.37%)
    7 / 72 (9.72%)
         occurrences all number
    1
    10
    Constipation
         subjects affected / exposed
    4 / 73 (5.48%)
    12 / 72 (16.67%)
         occurrences all number
    4
    16
    Diarrhoea
         subjects affected / exposed
    13 / 73 (17.81%)
    12 / 72 (16.67%)
         occurrences all number
    29
    32
    Dyspepsia
         subjects affected / exposed
    5 / 73 (6.85%)
    6 / 72 (8.33%)
         occurrences all number
    5
    6
    Flatulence
         subjects affected / exposed
    1 / 73 (1.37%)
    4 / 72 (5.56%)
         occurrences all number
    1
    4
    Gastrooesophageal reflux disease
         subjects affected / exposed
    5 / 73 (6.85%)
    6 / 72 (8.33%)
         occurrences all number
    6
    6
    Nausea
         subjects affected / exposed
    23 / 73 (31.51%)
    20 / 72 (27.78%)
         occurrences all number
    36
    38
    Vomiting
         subjects affected / exposed
    11 / 73 (15.07%)
    12 / 72 (16.67%)
         occurrences all number
    12
    23
    Infections and infestations
    COVID-19
         subjects affected / exposed
    10 / 73 (13.70%)
    8 / 72 (11.11%)
         occurrences all number
    10
    8
    Urinary tract infection
         subjects affected / exposed
    2 / 73 (2.74%)
    4 / 72 (5.56%)
         occurrences all number
    2
    4
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    11 / 73 (15.07%)
    12 / 72 (16.67%)
         occurrences all number
    13
    12

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    20 Sep 2021
    Amendment 2 was created primarily to add an interim analysis.

    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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