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    Clinical Trial Results:
    A Phase II Randomized, Double-blind, Placebo-controlled, Proof-of-Concept Study to Evaluate the Safety and Efficacy of Cotadutide in Participants with Non-cirrhotic Non-alcoholic Steatohepatitis with Fibrosis

    Summary
    EudraCT number
    		 2021-005484-53
    Trial protocol
    		 DE   GR   AT   ES   IT   FR   HU  
    Global end of trial date
    19 Apr 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 May 2025
    First version publication date
    03 May 2025
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    D5671C00006
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05364931
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AstraZeneca AB
    Sponsor organisation address
    Karlebyhusentrén, B674, Södertälje, Sweden, 151 85
    Public contact
    Global Clinical Lead, AstraZeneca, +1 877-240-9479, information.center@astrazeneca.com
    Scientific contact
    Global Clinical Lead, AstraZeneca, +1 877-240-9479, 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
    11 Jun 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    19 Apr 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Apr 2024
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    • To evaluate the safety and tolerability of cotadutide as compared with placebo in participants with non-cirrhotic NASH with fibrosis • To assess the immunogenicity of cotadutide
    Protection of trial subjects
    The study was conducted in accordance with ethical principles that had their origin in the Declaration of Helsinki and were consistent with International Committee on Harmonization of Good Clinical Practice (ICH GCP), the AstraZeneca policy on Bioethics and Human Biological Samples, and all applicable regulatory requirements.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    14 Jul 2022
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 22
    Country: Number of subjects enrolled
    Japan: 8
    Country: Number of subjects enrolled
    Malaysia: 3
    Country: Number of subjects enrolled
    Korea, Republic of: 2
    Country: Number of subjects enrolled
    Taiwan: 1
    Country: Number of subjects enrolled
    Thailand: 3
    Country: Number of subjects enrolled
    Austria: 3
    Country: Number of subjects enrolled
    Germany: 1
    Country: Number of subjects enrolled
    Greece: 1
    Country: Number of subjects enrolled
    Italy: 4
    Country: Number of subjects enrolled
    New Zealand: 1
    Country: Number of subjects enrolled
    South Africa: 1
    Country: Number of subjects enrolled
    Spain: 2
    Country: Number of subjects enrolled
    United Kingdom: 2
    Worldwide total number of subjects
    54
    EEA total number of subjects
    11
    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)
    41
    From 65 to 84 years
    13
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 The screening period was up to 56 days, during which time eligibility criteria were assessed and the participant received a liver biopsy if they did not have a historical biopsy that could be used to determine eligibility for the study.

    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
    		 Cotadutide 300 ug
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cotadutide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    300 ug daily

    Arm title
    		 Cotadutide 600 ug
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cotadutide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    600 ug daily

    Arm title
    		 Placebo 300 ug
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo for cotadutide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    300 ug daily

    Arm title
    		 Placebo 600 ug
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo for cotadutide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    600 ug daily

    Number of subjects in period 1
    		Cotadutide 300 ug Cotadutide 600 ug Placebo 300 ug Placebo 600 ug
    Started
    17
    18
    10
    9
    Completed
    14
    14
    8
    5
    Not completed
    3
    4
    2
    4
         Consent withdrawn by subject
    1
    1
    2
    3
         Adverse event, non-fatal
    -
    2
    -
    1
         Discontinued
    1
    -
    -
    -
         study terminated by sponsor
    -
    1
    -
    -
         Lost to follow-up
    1
    -
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Cotadutide 300 ug
    Reporting group description
    		 -

    Reporting group title
    Cotadutide 600 ug
    Reporting group description
    		 -

    Reporting group title
    Placebo 300 ug
    Reporting group description
    		 -

    Reporting group title
    Placebo 600 ug
    Reporting group description
    		 -

    Reporting group values
    		 Cotadutide 300 ug Cotadutide 600 ug Placebo 300 ug Placebo 600 ug Total
    Number of subjects
    		 17 18 10 9 54
    Age Categorical
    Units: Participants
        >= 65
    		 4 4 3 2 13
        >=50 - <65
    		 7 7 4 5 23
        < 50
    		 6 7 3 2 18
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 54.4 ( 12.4 ) 53.0 ( 12.6 ) 56.9 ( 11.6 ) 56.4 ( 9.4 ) -
    Sex: Female, Male
    Units: Participants
        Female
    		 11 10 4 6 31
        Male
    		 6 8 6 3 23
    Race/Ethnicity, Customized
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 1 1 2
        Asian
    		 5 9 2 2 18
        Black or African American
    		 0 1 0 0 1
        Multiple
    		 0 0 0 0 0
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0 0
        Not Reported
    		 1 0 0 0 1
        Other
    		 0 0 0 0 0
        White
    		 11 8 7 6 32

    End points

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    End points reporting groups
    Reporting group title
    Cotadutide 300 ug
    Reporting group description
    		 -

    Reporting group title
    Cotadutide 600 ug
    Reporting group description
    		 -

    Reporting group title
    Placebo 300 ug
    Reporting group description
    		 -

    Reporting group title
    Placebo 600 ug
    Reporting group description
    		 -

    Primary: Safety and tolerability will be evaluated in terms of AEs, vital signs, clinical and laboratory assessments, and ECG.

    		 Close Top of page
    End point title
    		 Safety and tolerability will be evaluated in terms of AEs, vital signs, clinical and laboratory assessments, and ECG. [1]
    End point description
    End point type
    Primary
    End point timeframe
    From first dose of IP through the end of study.
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The CSP was amended to stop enrollment into the trial early and in the same amendment all primary and secondary efficacy endpoints were reclassified as exploratory endpoints and the primary objective for the trial was changed to one related to safety. Analyses of safety were descriptive only and thus there were not statistical analyses of a primary endpoint.
    End point values
    		 Cotadutide 300 ug Cotadutide 600 ug Placebo 300 ug Placebo 600 ug
    Number of subjects analysed
    17
    18
    10
    9
    Units: Number of participants
        Number of participants with an adverse event
    16
    17
    8
    5
    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 IP through the end of study.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.1
    Reporting groups
    Reporting group title
    Cotadutide 300 ug
    Reporting group description
    		 Description (Arm-group)

    Reporting group title
    Placebo 600 ug
    Reporting group description
    		 Description (Arm-group)

    Reporting group title
    Placebo 300 ug
    Reporting group description
    		 Description (Arm-group)

    Reporting group title
    Cotadutide 600 ug
    Reporting group description
    		 Description (Arm-group)

    Serious adverse events
    		 Cotadutide 300 ug Placebo 600 ug Placebo 300 ug Cotadutide 600 ug
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 18 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Cardiac disorders
    Atrioventricular block complete
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 18 (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
    Atrioventricular block second degree
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 18 (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
    General disorders and administration site conditions
    Pacemaker generated arrhythmia
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    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: 1%
    Non-serious adverse events
    		 Cotadutide 300 ug Placebo 600 ug Placebo 300 ug Cotadutide 600 ug
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    16 / 17 (94.12%)
    5 / 9 (55.56%)
    8 / 10 (80.00%)
    17 / 18 (94.44%)
    Vascular disorders
    Hypotension
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    0
    1
    General disorders and administration site conditions
    Face oedema
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    0
    1
    Exercise tolerance decreased
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Early satiety
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Injection site bruising
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    2
    0
    0
    1
    Injection site pain
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Injection site pruritus
         subjects affected / exposed
    0 / 17 (0.00%)
    2 / 9 (22.22%)
    0 / 10 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Injection site reaction
         subjects affected / exposed
    2 / 17 (11.76%)
    0 / 9 (0.00%)
    2 / 10 (20.00%)
    0 / 18 (0.00%)
         occurrences all number
    2
    0
    3
    0
    Pyrexia
         subjects affected / exposed
    2 / 17 (11.76%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
    0 / 18 (0.00%)
         occurrences all number
    2
    0
    1
    0
    Injection site haemorrhage
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    1
    1
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Reproductive system and breast disorders
    Testicular pain
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Obstructive sleep apnoea syndrome
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Oropharyngeal pain
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Productive cough
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Sinus congestion
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Cough
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Depression
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Anxiety
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    1
    0
    0
    1
    Amylase increased
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    0
    1
    Blood pressure increased
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    0
    1
    Glycosylated haemoglobin increased
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 9 (11.11%)
    1 / 10 (10.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Lipase increased
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 9 (11.11%)
    0 / 10 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Weight decreased
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    2 / 18 (11.11%)
         occurrences all number
    0
    0
    0
    2
    Blood cholesterol increased
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    2 / 18 (11.11%)
         occurrences all number
    1
    0
    0
    3
    Injury, poisoning and procedural complications
    Fibula fracture
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    0
    1
    Fall
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Epicondylitis
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Contusion
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 9 (11.11%)
    0 / 10 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Head injury
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Tendon rupture
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 9 (11.11%)
    0 / 10 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Ligament sprain
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Joint injury
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Immunisation reaction
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    1
    0
    0
    1
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Sinus tachycardia
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    0
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    3 / 17 (17.65%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    3
    0
    0
    1
    Headache
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 9 (0.00%)
    2 / 10 (20.00%)
    0 / 18 (0.00%)
         occurrences all number
    2
    0
    2
    0
    Lethargy
         subjects affected / exposed
    2 / 17 (11.76%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Somnolence
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    0
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Ear and labyrinth disorders
    Excessive cerumen production
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Vertigo
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Gastrointestinal disorders
    Food poisoning
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    0
    1
    Abdominal discomfort
         subjects affected / exposed
    2 / 17 (11.76%)
    1 / 9 (11.11%)
    0 / 10 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    2
    1
    0
    1
    Abdominal distension
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Abdominal pain upper
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    1
    0
    0
    1
    Constipation
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 9 (11.11%)
    1 / 10 (10.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    1
    1
    Diarrhoea
         subjects affected / exposed
    3 / 17 (17.65%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
    3 / 18 (16.67%)
         occurrences all number
    3
    0
    1
    7
    Dry mouth
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Dyspepsia
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    0
    1
    Flatulence
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Gastrointestinal pain
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    2 / 18 (11.11%)
         occurrences all number
    0
    0
    0
    2
    Nausea
         subjects affected / exposed
    5 / 17 (29.41%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
    9 / 18 (50.00%)
         occurrences all number
    7
    0
    1
    14
    Toothache
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Umbilical hernia
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    0
    1
    Vomiting
         subjects affected / exposed
    5 / 17 (29.41%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    6 / 18 (33.33%)
         occurrences all number
    7
    0
    0
    8
    Hepatobiliary disorders
    Gallbladder polyp
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    2 / 18 (11.11%)
         occurrences all number
    0
    0
    0
    2
    Onychoclasis
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    1
    0
    0
    1
    Pruritus
         subjects affected / exposed
    0 / 17 (0.00%)
    2 / 9 (22.22%)
    0 / 10 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Rash
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Vitiligo
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 9 (11.11%)
    0 / 10 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Flank pain
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    1
    0
    0
    1
    Intervertebral disc degeneration
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Intervertebral disc protrusion
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Osteopenia
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Rotator cuff syndrome
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Tendon disorder
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 9 (11.11%)
    0 / 10 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    1
    0
    0
    1
    Folliculitis
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Gingivitis
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    0
    1
    Helicobacter gastritis
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    0
    1
    Influenza
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    2 / 18 (11.11%)
         occurrences all number
    1
    0
    0
    2
    Nasopharyngitis
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    4 / 18 (22.22%)
         occurrences all number
    0
    0
    0
    4
    Otitis media
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    0
    1
    Pharyngitis
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    0
    1
    Vulvovaginal candidiasis
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    0
    1
    Urinary tract infection
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 17 (11.76%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    2
    0
    0
    1
    Covid-19
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    5 / 18 (27.78%)
         occurrences all number
    1
    0
    0
    5
    Metabolism and nutrition disorders
    Iron deficiency
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    1
    0
    0
    1
    Hypoglycaemia
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    0
    3
    Hyperamylasaemia
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    0
    1
    Folate deficiency
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Decreased appetite
         subjects affected / exposed
    3 / 17 (17.65%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    4 / 18 (22.22%)
         occurrences all number
    3
    0
    0
    4
    Type 2 diabetes mellitus
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Increased appetite
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 9 (0.00%)
    1 / 10 (10.00%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Vitamin d deficiency
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Vitamin b12 deficiency
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    07 Nov 2022
    Version No 2.0
    15 May 2023
    Version No 3.0

    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
    For support, Contact us.
    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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