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    Clinical Trial Results:
    A Randomised, Double-blind, Placebo-controlled, Multi-centre Phase 2b Study to Evaluate the Efficacy, Safety and Tolerability of AZD2693 in Participants with Non-cirrhotic Non-alcoholic Steatohepatitis (NASH) with Fibrosis Who Are Carriers of the PNPLA3 rs738409 148M Risk Allele

    Summary
    EudraCT number
    		 2022-001629-65
    Trial protocol
    		 IT  
    Global end of trial date
    04 Nov 2025

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 Oct 2026
    First version publication date
    03 Oct 2026
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    D7830C00004
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05809934
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AstraZeneca
    Sponsor organisation address
    151 85, Södertälje, Sweden,
    Public contact
    Global Clinical Lead, AstraZeneca, +1 8772409479, information.center@astrazeneca.com
    Scientific contact
    Global Clinical Lead, AstraZeneca, +1 8772409479, information.center@astrazeneca.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
    04 Nov 2025
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    04 Nov 2025
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Nov 2025
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the effect of AZD2693 versus placebo on histological resolution of NASH in participants with non-cirrhotic NASH with fibrosis and PNPLA3 risk allele carriers after 52 weeks
    Protection of trial subjects
    This study was performed in compliance with International Council for Harmonisation (ICH) Good Clinical Practice, including the archiving of essential documents.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Mar 2023
    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
    Argentina: 5
    Country: Number of subjects enrolled
    Brazil: 14
    Country: Number of subjects enrolled
    Chile: 7
    Country: Number of subjects enrolled
    China: 10
    Country: Number of subjects enrolled
    Colombia: 1
    Country: Number of subjects enrolled
    Germany: 2
    Country: Number of subjects enrolled
    Hong Kong: 5
    Country: Number of subjects enrolled
    Italy: 14
    Country: Number of subjects enrolled
    Japan: 30
    Country: Number of subjects enrolled
    Malaysia: 4
    Country: Number of subjects enrolled
    Mexico: 32
    Country: Number of subjects enrolled
    Peru: 3
    Country: Number of subjects enrolled
    Philippines: 5
    Country: Number of subjects enrolled
    Korea, Republic of: 1
    Country: Number of subjects enrolled
    Singapore: 3
    Country: Number of subjects enrolled
    Spain: 4
    Country: Number of subjects enrolled
    Taiwan: 1
    Country: Number of subjects enrolled
    Thailand: 3
    Country: Number of subjects enrolled
    Türkiye: 5
    Country: Number of subjects enrolled
    United States: 66
    Country: Number of subjects enrolled
    Viet Nam: 1
    Worldwide total number of subjects
    216
    EEA total number of subjects
    20
    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)
    172
    From 65 to 84 years
    44
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Screening is performed up to 10 weeks before randomization.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer, Data analyst, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 AZD2693 25 mg
    Arm description
    		 Participants in this arm will receive AZD2693 25 mg
    Arm type
    		 Experimental

    Investigational medicinal product name
    AZD2693
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    25 mg daily

    Arm title
    		 AZD2693 50 mg
    Arm description
    		 Participants in this arm will receive AZD2693 50 mg
    Arm type
    		 Experimental

    Investigational medicinal product name
    AZD2693
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    50 mg daily

    Arm title
    		 Placebo
    Arm description
    		 Participants in this arm will receive placebo
    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
    Placebo tablet once daily

    Number of subjects in period 1
    		AZD2693 25 mg AZD2693 50 mg Placebo
    Started
    73
    69
    74
    Completed
    67
    61
    69
    Not completed
    6
    8
    5
         Consent withdrawn by subject
    5
    6
    5
         SAE
    -
    1
    -
         Lost to follow-up
    1
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    AZD2693 25 mg
    Reporting group description
    		 Participants in this arm will receive AZD2693 25 mg

    Reporting group title
    AZD2693 50 mg
    Reporting group description
    		 Participants in this arm will receive AZD2693 50 mg

    Reporting group title
    Placebo
    Reporting group description
    		 Participants in this arm will receive placebo

    Reporting group values
    		 AZD2693 25 mg AZD2693 50 mg Placebo Total
    Number of subjects
    		 73 69 74 216
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 60 56 56 172
        From 65-84 years
    		 13 13 18 44
        85 years and over
    		 0 0 0 0
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 53.7 ( 13.0 ) 51.8 ( 13.3 ) 53.7 ( 13.6 ) -
    Sex: Female, Male
    Units: Participants
        Female
    		 39 41 37 117
        Male
    		 34 28 37 99
    Race (NIH/OMB)
    Units: Subjects
        AMERICAN INDIAN OR ALASKA NATIVE
    		 5 0 2 7
        ASIAN
    		 19 19 27 65
        BLACK OR AFRICAN AMERICAN
    		 0 0 3 3
        MULTIPLE
    		 1 0 0 1
        NOT REPORTED
    		 2 4 2 8
        OTHER
    		 0 5 9 14
        WHITE
    		 46 41 31 118
    Region of Enrollment
    ARG=Argentina, BRA=Brazil, CHL=Chile, CHN=China, COL=Colombia, DEU=Germany, ESP=Spain, HKG=Hong Kong, ITA=Italy, JPN=Japan, MAL=Malaysia, MEX=Mexico, MYS=Malaysia, PER=Peru, KOR=Republic of Korea, SGP=Singapore, TWN=Taiwan, THA=Thailand, TUR=Turkey, USA=United States of America, VNM=Vietnam
    Units: Subjects
        ARG
    		 1 3 1 5
        BRA
    		 3 3 8 14
        CHL
    		 1 6 0 7
        CHN
    		 2 4 4 10
        COL
    		 1 0 0 1
        DEU
    		 2 0 0 2
        ESP
    		 2 1 1 4
        HKG
    		 2 3 0 5
        ITA
    		 6 4 4 14
        JPN
    		 8 8 14 30
        KOR
    		 1 0 0 1
        MEX
    		 8 11 13 32
        MYS
    		 3 1 0 4
        PER
    		 2 0 1 3
        PHL
    		 1 1 3 5
        SGP
    		 1 1 1 3
        THA
    		 1 1 1 3
        TUR
    		 4 1 0 5
        TWN
    		 0 0 1 1
        USA
    		 24 21 21 66
        VNM
    		 0 0 1 1

    End points

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    End points reporting groups
    Reporting group title
    AZD2693 25 mg
    Reporting group description
    		 Participants in this arm will receive AZD2693 25 mg

    Reporting group title
    AZD2693 50 mg
    Reporting group description
    		 Participants in this arm will receive AZD2693 50 mg

    Reporting group title
    Placebo
    Reporting group description
    		 Participants in this arm will receive placebo

    Primary: Proportion of participants achieving NASH resolution without worsening of fibrosis based on histology after 52 weeks treatment

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    End point title
    		 Proportion of participants achieving NASH resolution without worsening of fibrosis based on histology after 52 weeks treatment
    End point description
    To assess the effect of AZD2693 versus placebo on histological resolution of NASH in participants with non-cirrhotic NASH with fibrosis and PNPLA3 risk allele carriers after 52 weeks
    End point type
    Primary
    End point timeframe
    From baseline to week 54
    End point values
    		 AZD2693 25 mg AZD2693 50 mg Placebo
    Number of subjects analysed
    73
    69
    74
    Units: Participants
        Participants with response
    4
    1
    5
    Statistical analysis title
    		 Comparing groups: AZD2693 50 mg vs Placebo
    Comparison groups
    AZD2693 50 mg v Placebo
    Number of subjects included in analysis
    143
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.116
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.02
         upper limit
    		 1.78
    Statistical analysis title
    		 Comparing groups: AZD2693 25 mg vs Placebo
    Comparison groups
    AZD2693 25 mg v Placebo
    Number of subjects included in analysis
    147
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.783
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.83
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.21
         upper limit
    		 3.23

    Secondary: Proportion of participants with at least one stage of liver fibrosis improvement with no worsening of NASH based on biopsy after 52 weeks treatment

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    End point title
    		 Proportion of participants with at least one stage of liver fibrosis improvement with no worsening of NASH based on biopsy after 52 weeks treatment
    End point description
    To assess the effects of AZD2693 versus placebo on histological fibrosis improvement
    End point type
    Secondary
    End point timeframe
    From baseline to week 54
    End point values
    		 AZD2693 25 mg AZD2693 50 mg Placebo
    Number of subjects analysed
    73
    69
    74
    Units: Participants
        Participants with response
    12
    6
    8
    Statistical analysis title
    		 Comparing groups: AZD2693 50 mg vs Placebo
    Comparison groups
    AZD2693 50 mg v Placebo
    Number of subjects included in analysis
    143
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.693
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.26
         upper limit
    		 2.44
    Statistical analysis title
    		 Comparing groups: AZD2693 25 mg vs Placebo
    Comparison groups
    AZD2693 25 mg v Placebo
    Number of subjects included in analysis
    147
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.32
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.64
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.62
         upper limit
    		 4.37

    Secondary: Proportion of participants with ≥ 2-point improvement from baseline in NAS based on biopsy after 52 weeks treatment

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    End point title
    		 Proportion of participants with ≥ 2-point improvement from baseline in NAS based on biopsy after 52 weeks treatment
    End point description
    To assess the effect of AZD2693 versus placebo on ≥ 2-point improvement in NAS
    End point type
    Secondary
    End point timeframe
    From baseline to week 54
    End point values
    		 AZD2693 25 mg AZD2693 50 mg Placebo
    Number of subjects analysed
    73
    69
    74
    Units: Participants
        Participants with response
    22
    12
    23
    Statistical analysis title
    		 Comparing groups: AZD2693 50 mg vs Placebo
    Comparison groups
    AZD2693 50 mg v Placebo
    Number of subjects included in analysis
    143
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.053
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.45
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.2
         upper limit
    		 1.01
    Statistical analysis title
    		 Comparing groups: AZD2693 25 mg vs Placebo
    Comparison groups
    AZD2693 25 mg v Placebo
    Number of subjects included in analysis
    147
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.885
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.95
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.47
         upper limit
    		 1.92

    Secondary: Proportion of participants with improvement in fibrosis by at least one stage based on biopsy after 52 weeks treatment

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    End point title
    		 Proportion of participants with improvement in fibrosis by at least one stage based on biopsy after 52 weeks treatment
    End point description
    To assess the effect of AZD2693 versus placebo on improvement in fibrosis by at least one stage
    End point type
    Secondary
    End point timeframe
    From baseline to week 54
    End point values
    		 AZD2693 25 mg AZD2693 50 mg Placebo
    Number of subjects analysed
    73
    69
    74
    Units: Participants
        Participants with response
    14
    7
    10
    Statistical analysis title
    		 Comparing groups: AZD2693 50 mg vs Placebo
    Comparison groups
    AZD2693 50 mg v Placebo
    Number of subjects included in analysis
    143
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.542
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.73
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.26
         upper limit
    		 2.03
    Statistical analysis title
    		 Comparing groups: AZD2693 25 mg vs Placebo
    Comparison groups
    AZD2693 25 mg v Placebo
    Number of subjects included in analysis
    147
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.375
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.52
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.61
         upper limit
    		 3.8

    Other pre-specified: Number of participants with Adverse Events/Serious Adverse Events (AEs/SAEs) and abnormal laboratory test results

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    End point title
    		 Number of participants with Adverse Events/Serious Adverse Events (AEs/SAEs) and abnormal laboratory test results
    End point description
    Haematology, urinalysis, clinical chemistry and eGFR. Number of participants with abnormalities. A result of >=++ for urinalysis (dipstick) results means ++ or worse (+++ or ++++).
    End point type
    Other pre-specified
    End point timeframe
    Baseline to 64 weeks
    End point values
    		 AZD2693 25 mg AZD2693 50 mg Placebo
    Number of subjects analysed
    73
    69
    74
    Units: Participants
        ALT > 3ULN
    18
    33
    10
        ALP > 3ULN
    1
    0
    0
        AST > 3ULN
    11
    18
    11
        direct Bilirubin > ULN
    5
    7
    4
        Creatinine > ULN
    1
    2
    7
        B-platelet count > ULN
    9
    5
    9
        Blood >= ++
    6
    14
    7
        Glucose >= ++
    13
    24
    29
        Protein >= ++
    6
    4
    4
        eGFR > 25% decrease
    1
    3
    10
    No statistical analyses for this end point

    Other pre-specified: Number of participants with abnormal laboratory test results

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    End point title
    		 Number of participants with abnormal laboratory test results
    End point description
    Vital signs and electrocardiogram (ECG) assessments. Number of participants with abnormalities.
    End point type
    Other pre-specified
    End point timeframe
    Baseline to 64 weeks
    End point values
    		 AZD2693 25 mg AZD2693 50 mg Placebo
    Number of subjects analysed
    73
    69
    74
    Units: Participants
        Diastolic blood pressure from normal to high
    15
    26
    25
        Systolic blood pressure from normal to high
    29
    30
    28
        Pulse rate from normal to high
    2
    3
    7
        Temperature from normal to high
    12
    10
    18
        QTcF increase from baseline by more than 60 ms
    3
    1
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first dose of study drug until last study visit
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    28.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    AZD2693 25 mg
    Reporting group description
    		 -

    Reporting group title
    AZD2693 50 mg
    Reporting group description
    		 -

    Serious adverse events
    		 Placebo AZD2693 25 mg AZD2693 50 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 74 (8.11%)
    6 / 73 (8.22%)
    3 / 69 (4.35%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Injury, poisoning and procedural complications
    Radius fracture
         subjects affected / exposed
    1 / 74 (1.35%)
    1 / 73 (1.37%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Hypotension
         subjects affected / exposed
    0 / 74 (0.00%)
    1 / 73 (1.37%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Myocardial ischaemia
         subjects affected / exposed
    0 / 74 (0.00%)
    0 / 73 (0.00%)
    1 / 69 (1.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bradycardia
         subjects affected / exposed
    1 / 74 (1.35%)
    0 / 73 (0.00%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebral infarction
         subjects affected / exposed
    0 / 74 (0.00%)
    1 / 73 (1.37%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 74 (1.35%)
    0 / 73 (0.00%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Melaena
         subjects affected / exposed
    1 / 74 (1.35%)
    0 / 73 (0.00%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Large intestine polyp
         subjects affected / exposed
    1 / 74 (1.35%)
    0 / 73 (0.00%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain lower
         subjects affected / exposed
    0 / 74 (0.00%)
    1 / 73 (1.37%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    1 / 74 (1.35%)
    0 / 73 (0.00%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Autoimmune hepatitis
         subjects affected / exposed
    0 / 74 (0.00%)
    1 / 73 (1.37%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    0 / 74 (0.00%)
    0 / 73 (0.00%)
    1 / 69 (1.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Neck pain
         subjects affected / exposed
    1 / 74 (1.35%)
    0 / 73 (0.00%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Costochondritis
         subjects affected / exposed
    0 / 74 (0.00%)
    1 / 73 (1.37%)
    0 / 69 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Neurosyphilis
         subjects affected / exposed
    0 / 74 (0.00%)
    0 / 73 (0.00%)
    1 / 69 (1.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo AZD2693 25 mg AZD2693 50 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    52 / 74 (70.27%)
    47 / 73 (64.38%)
    47 / 69 (68.12%)
    Investigations
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 74 (1.35%)
    1 / 73 (1.37%)
    4 / 69 (5.80%)
         occurrences all number
    1
    1
    6
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 74 (1.35%)
    3 / 73 (4.11%)
    9 / 69 (13.04%)
         occurrences all number
    2
    3
    10
    Vascular disorders
    Hypertension
         subjects affected / exposed
    4 / 74 (5.41%)
    1 / 73 (1.37%)
    2 / 69 (2.90%)
         occurrences all number
    4
    1
    2
    Nervous system disorders
    Headache
         subjects affected / exposed
    5 / 74 (6.76%)
    7 / 73 (9.59%)
    8 / 69 (11.59%)
         occurrences all number
    6
    8
    9
    Dizziness
         subjects affected / exposed
    4 / 74 (5.41%)
    4 / 73 (5.48%)
    1 / 69 (1.45%)
         occurrences all number
    4
    5
    2
    General disorders and administration site conditions
    Injection site pain
         subjects affected / exposed
    1 / 74 (1.35%)
    4 / 73 (5.48%)
    4 / 69 (5.80%)
         occurrences all number
    1
    5
    9
    Injection site erythema
         subjects affected / exposed
    0 / 74 (0.00%)
    6 / 73 (8.22%)
    8 / 69 (11.59%)
         occurrences all number
    0
    14
    24
    Fatigue
         subjects affected / exposed
    5 / 74 (6.76%)
    2 / 73 (2.74%)
    3 / 69 (4.35%)
         occurrences all number
    5
    2
    4
    Injection site pruritus
         subjects affected / exposed
    0 / 74 (0.00%)
    2 / 73 (2.74%)
    6 / 69 (8.70%)
         occurrences all number
    0
    3
    9
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    4 / 74 (5.41%)
    4 / 73 (5.48%)
    5 / 69 (7.25%)
         occurrences all number
    4
    4
    7
    Gastrooesophageal reflux disease
         subjects affected / exposed
    4 / 74 (5.41%)
    0 / 73 (0.00%)
    1 / 69 (1.45%)
         occurrences all number
    4
    0
    1
    Diarrhoea
         subjects affected / exposed
    11 / 74 (14.86%)
    3 / 73 (4.11%)
    7 / 69 (10.14%)
         occurrences all number
    11
    4
    10
    Abdominal pain upper
         subjects affected / exposed
    1 / 74 (1.35%)
    6 / 73 (8.22%)
    1 / 69 (1.45%)
         occurrences all number
    1
    7
    1
    Abdominal pain
         subjects affected / exposed
    2 / 74 (2.70%)
    0 / 73 (0.00%)
    7 / 69 (10.14%)
         occurrences all number
    3
    0
    8
    Abdominal distension
         subjects affected / exposed
    4 / 74 (5.41%)
    1 / 73 (1.37%)
    0 / 69 (0.00%)
         occurrences all number
    4
    2
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    6 / 74 (8.11%)
    1 / 73 (1.37%)
    1 / 69 (1.45%)
         occurrences all number
    7
    1
    1
    Skin and subcutaneous tissue disorders
    Erythema
         subjects affected / exposed
    1 / 74 (1.35%)
    4 / 73 (5.48%)
    2 / 69 (2.90%)
         occurrences all number
    2
    13
    8
    Rash
         subjects affected / exposed
    2 / 74 (2.70%)
    2 / 73 (2.74%)
    4 / 69 (5.80%)
         occurrences all number
    2
    2
    4
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    4 / 74 (5.41%)
    2 / 73 (2.74%)
    4 / 69 (5.80%)
         occurrences all number
    5
    5
    5
    Back pain
         subjects affected / exposed
    6 / 74 (8.11%)
    6 / 73 (8.22%)
    3 / 69 (4.35%)
         occurrences all number
    7
    8
    3
    Pain in extremity
         subjects affected / exposed
    2 / 74 (2.70%)
    4 / 73 (5.48%)
    0 / 69 (0.00%)
         occurrences all number
    2
    5
    0
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    2 / 74 (2.70%)
    8 / 73 (10.96%)
    7 / 69 (10.14%)
         occurrences all number
    2
    11
    8
    Upper respiratory tract infection
         subjects affected / exposed
    4 / 74 (5.41%)
    7 / 73 (9.59%)
    5 / 69 (7.25%)
         occurrences all number
    5
    8
    5
    Pharyngitis
         subjects affected / exposed
    5 / 74 (6.76%)
    1 / 73 (1.37%)
    1 / 69 (1.45%)
         occurrences all number
    7
    1
    1
    Gastroenteritis
         subjects affected / exposed
    3 / 74 (4.05%)
    5 / 73 (6.85%)
    3 / 69 (4.35%)
         occurrences all number
    3
    6
    3
    Influenza
         subjects affected / exposed
    4 / 74 (5.41%)
    1 / 73 (1.37%)
    3 / 69 (4.35%)
         occurrences all number
    4
    1
    3
    Nasopharyngitis
         subjects affected / exposed
    11 / 74 (14.86%)
    6 / 73 (8.22%)
    9 / 69 (13.04%)
         occurrences all number
    15
    7
    10
    COVID-19
         subjects affected / exposed
    3 / 74 (4.05%)
    4 / 73 (5.48%)
    7 / 69 (10.14%)
         occurrences all number
    3
    4
    7
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    4 / 74 (5.41%)
    1 / 73 (1.37%)
    0 / 69 (0.00%)
         occurrences all number
    4
    3
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    14 Feb 2023
    CSP v2.0; Current data supports removing the pre-dose platelet count visit (local lab, within 1 week of dosing to have a fresh platelet count) after Visit 11 and onwards, to reduce the participant visit burden in the study. After Visit 11 and onwards, the monthly ongoing safety surveillance and review of the independent Safety Monitoring Committee would be considered sufficient to detect any drop in platelet count. Actions in case of development of thrombocytopenia are described in Appendix F.
    04 Aug 2023
    CSP V3.0; The Clinical Study Protocol (CSP), version 3.0, was updated to exclude the 50 mg exploratory heterozygous cohort. Heterozygous safety data had been reviewed during safety review committee (SRC) prior to the start of the Ph2b study, with no safety stopping criteria met and PK analysis in line with expectations. Efficacy data (liver fat content) is now available from the global multiple ascending dose study(GMAD) in the heterozygote participant cohort. The participants received 25 mg, 3 monthly doses and were followed for 16 weeks after the last dose. Review of the data from the ongoing study demonstrate a change in the benefit:risk ratio because there is not sufficient evidence of potential treatment benefit to support continued inclusion of this population in the D7830c00004 study.
    01 Jul 2024
    CSP v4.0; Current data supports removing the pre-dose platelet count visit (local lab, within 1 week of dosing to have a fresh platelet count) after Visit 11 and onwards, to reduce the participant visit burden in the study. After Visit 11 and onwards, the monthly ongoing safety surveillance and review of the independent Safety Monitoring Committee would be considered sufficient to detect any drop in platelet count. Actions in case of development of thrombocytopenia are described in Appendix F.

    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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