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    Clinical Trial Results:
    Investigation of safety and efficacy of NNC0174-0833 for weight management – a dose finding trial

    Summary
    EudraCT number
    2018-001945-14
    Trial protocol
    GB   FI   DK   PL  
    Global end of trial date
    25 Mar 2021

    Results information
    Results version number
    v1(current)
    This version publication date
    09 Feb 2022
    First version publication date
    09 Feb 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    NN9838-4433
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03856047
    WHO universal trial number (UTN)
    U1111-1214-0429
    Sponsors
    Sponsor organisation name
    Novo Nordisk A/S
    Sponsor organisation address
    Novo Allé, Bagsvaerd, Denmark, 2880
    Public contact
    Clinical Reporting Office (1452), Novo Nordisk A/S, clinicaltrials@novonordisk.com
    Scientific contact
    Clinical Reporting Office (1452), Novo Nordisk A/S, clinicaltrials@novonordisk.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 Nov 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    02 Mar 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Mar 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of the trial was to compare the dose-response of increasing doses of NNC0174-0833 once weekly (OW) versus placebo and versus liraglutide 3.0 mg once daily (OD) on body weight, in subjects with overweight or obesity, when added as an adjunct to a reduced-calorie diet and increased physical activity.
    Protection of trial subjects
    The trial was conducted in accordance with the Declaration of Helsinki (October 2013) and International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Good Clinical Practice, including archiving of essential documents (November 2016), and 21 code of federal regulations (CFR) 312.120.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    01 Mar 2019
    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
    Canada: 43
    Country: Number of subjects enrolled
    Denmark: 45
    Country: Number of subjects enrolled
    Finland: 86
    Country: Number of subjects enrolled
    United Kingdom: 78
    Country: Number of subjects enrolled
    Ireland: 23
    Country: Number of subjects enrolled
    Japan: 70
    Country: Number of subjects enrolled
    Poland: 60
    Country: Number of subjects enrolled
    Serbia: 40
    Country: Number of subjects enrolled
    United States: 205
    Country: Number of subjects enrolled
    South Africa: 56
    Worldwide total number of subjects
    706
    EEA total number of subjects
    214
    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)
    629
    From 65 to 84 years
    77
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The trial was conducted at 57 sites in 10 countries as follows: Canada (5), Denmark (2), Finland (4), Ireland (1), Japan (3), Poland (3), Serbia (5), South Africa (5), United Kingdom (7), United States of America (22).

    Pre-assignment
    Screening details
    Subjects were randomized in 6:1 ratio between active treatment (cagrilintide and liraglutide) arms and placebo arms. The 5 different cagrilintide placebo arms and one liraglutide placebo arm were pooled into one placebo group in the main analyses. Subjects received treatments as an adjunct to reduced-calorie diet and increased physical activity.

    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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Cagrilintide 0.3 mg
    Arm description
    Subjects were to receive once weekly subcutaneous (s.c.) injection of 0.3 milligrams (mg) cagrilintide for 26 weeks, using NovoPen® 4 pen-injector.
    Arm type
    Experimental

    Investigational medicinal product name
    Cagrilintide
    Investigational medicinal product code
    NNC0174-0833 A 10 mg/mL cartridge
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects were to receive once weekly s.c. injection of 0.3 mg cagrilintide for 26 weeks, using NovoPen® 4 pen-injector.

    Arm title
    Cagrilintide 0.6 mg
    Arm description
    Subjects were to receive once weekly s.c. injection of 0.6 mg cagrilintide for 26 weeks, using NovoPen® 4 pen-injector.
    Arm type
    Experimental

    Investigational medicinal product name
    Cagrilintide
    Investigational medicinal product code
    NNC0174-0833 A 10 mg/mL cartridge
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects were to receive once weekly s.c. injection of 0.6 mg cagrilintide for 26 weeks, using NovoPen® 4 pen-injector.

    Arm title
    Cagrilintide 1.2 mg
    Arm description
    Subjects were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Subjects initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 1.2 mg was reached: 0.6 mg (week 0) and 1.2 mg (week 2 to week 26).
    Arm type
    Experimental

    Investigational medicinal product name
    Cagrilintide
    Investigational medicinal product code
    NNC0174-0833 A 10 mg/mL cartridge
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Subjects initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 1.2 mg was reached: 0.6 mg (week 0) and 1.2 mg (week 2 to week 26).

    Arm title
    Cagrilintide 2.4 mg
    Arm description
    Subjects were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Subjects initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 2.4 mg was reached: 0.6 mg (week 0), 1.2 mg (week 2), 2.4 mg (week 4 to week 26).
    Arm type
    Experimental

    Investigational medicinal product name
    Cagrilintide
    Investigational medicinal product code
    NNC0174-0833 A 10 mg/mL cartridge
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Subjects initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 2.4 mg was reached: 0.6 mg (week 0), 1.2 mg (week 2), 2.4 mg (week 4 to week 26).

    Arm title
    Cagrilintide 4.5 mg
    Arm description
    Subjects were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Subjects initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 4.5 mg was reached: 0.6 mg (week 0), 1.2 mg (week 2), 2.4 mg (week 4), 4.5 mg (week 6 to week 26).
    Arm type
    Experimental

    Investigational medicinal product name
    Cagrilintide
    Investigational medicinal product code
    NNC0174-0833 A 10 mg/mL cartridge
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Subjects initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 4.5 mg was reached: 0.6 mg (week 0), 1.2 mg (week 2), 2.4 mg (week 4), 4.5 mg (week 6 to week 26).

    Arm title
    Liraglutide 3.0 mg
    Arm description
    Subjects were to receive once daily s.c. injection of liraglutide for 26 weeks, using PDS290 pen-injector. Subjects initially received 0.6 mg of liraglutide and the dose was then escalated every week until the target dose of 3.0 mg was reached: 0.6 mg (week 0), 1.2 mg (week 1), 1.8 mg (week 2), 2.4 mg (week 3), 3.0 mg (week 4 to week 26).
    Arm type
    Experimental

    Investigational medicinal product name
    Liraglutide
    Investigational medicinal product code
    Other name
    Saxenda
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects were to receive once daily s.c. injection of liraglutide for 26 weeks, using PDS290 pen-injector. Subjects initially received 0.6 mg of liraglutide and the dose was then escalated every other week until the target dose of 3.0 mg was reached: 0.6 mg (week 0), 1.2 mg (week 1), 1.8 mg (week 2), 2.4 mg (week 3), 3.0 mg (week 4 to week 26).

    Arm title
    Pooled placebo
    Arm description
    Subjects were to receive once weekly / once daily s.c. injection of placebo matched to cagrilintide / liraglutide (0.3 mg, 0.6 mg, 1.2 mg, 2.4 mg or 4.5 mg / 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, 3.0 mg ) for 26 weeks respectively.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects were to receive once weekly / once daily s.c. injection of placebo matched to cagrilintide / liraglutide (0.3 mg, 0.6 mg, 1.2 mg, 2.4 mg or 4.5 mg / 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, 3.0 mg ) for 26 weeks respectively.

    Number of subjects in period 1
    Cagrilintide 0.3 mg Cagrilintide 0.6 mg Cagrilintide 1.2 mg Cagrilintide 2.4 mg Cagrilintide 4.5 mg Liraglutide 3.0 mg Pooled placebo
    Started
    101
    100
    102
    102
    101
    99
    101
    Full analysis set
    101
    100
    102
    102
    101
    99
    101
    Safety analysis set
    101
    100
    102
    102
    101
    99
    101
    Completed
    97
    97
    98
    101
    94
    95
    95
    Not completed
    4
    3
    4
    1
    7
    4
    6
         Consent withdrawn by subject
    -
    1
    1
    -
    3
    -
    2
         Lost to follow-up
    4
    2
    3
    1
    4
    4
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Cagrilintide 0.3 mg
    Reporting group description
    Subjects were to receive once weekly subcutaneous (s.c.) injection of 0.3 milligrams (mg) cagrilintide for 26 weeks, using NovoPen® 4 pen-injector.

    Reporting group title
    Cagrilintide 0.6 mg
    Reporting group description
    Subjects were to receive once weekly s.c. injection of 0.6 mg cagrilintide for 26 weeks, using NovoPen® 4 pen-injector.

    Reporting group title
    Cagrilintide 1.2 mg
    Reporting group description
    Subjects were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Subjects initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 1.2 mg was reached: 0.6 mg (week 0) and 1.2 mg (week 2 to week 26).

    Reporting group title
    Cagrilintide 2.4 mg
    Reporting group description
    Subjects were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Subjects initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 2.4 mg was reached: 0.6 mg (week 0), 1.2 mg (week 2), 2.4 mg (week 4 to week 26).

    Reporting group title
    Cagrilintide 4.5 mg
    Reporting group description
    Subjects were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Subjects initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 4.5 mg was reached: 0.6 mg (week 0), 1.2 mg (week 2), 2.4 mg (week 4), 4.5 mg (week 6 to week 26).

    Reporting group title
    Liraglutide 3.0 mg
    Reporting group description
    Subjects were to receive once daily s.c. injection of liraglutide for 26 weeks, using PDS290 pen-injector. Subjects initially received 0.6 mg of liraglutide and the dose was then escalated every week until the target dose of 3.0 mg was reached: 0.6 mg (week 0), 1.2 mg (week 1), 1.8 mg (week 2), 2.4 mg (week 3), 3.0 mg (week 4 to week 26).

    Reporting group title
    Pooled placebo
    Reporting group description
    Subjects were to receive once weekly / once daily s.c. injection of placebo matched to cagrilintide / liraglutide (0.3 mg, 0.6 mg, 1.2 mg, 2.4 mg or 4.5 mg / 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, 3.0 mg ) for 26 weeks respectively.

    Reporting group values
    Cagrilintide 0.3 mg Cagrilintide 0.6 mg Cagrilintide 1.2 mg Cagrilintide 2.4 mg Cagrilintide 4.5 mg Liraglutide 3.0 mg Pooled placebo Total
    Number of subjects
    101 100 102 102 101 99 101 706
    Age Categorical
    Units: Subjects
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    53.5 ( 10.3 ) 53.2 ( 11.0 ) 52.1 ( 8.7 ) 52.7 ( 9.8 ) 51.5 ( 12.7 ) 51.5 ( 9.3 ) 51.4 ( 11.9 ) -
    Gender Categorical
    Units: Subjects
        Female
    56 62 63 75 56 65 59 436
        Male
    45 38 39 27 45 34 42 270

    End points

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    End points reporting groups
    Reporting group title
    Cagrilintide 0.3 mg
    Reporting group description
    Subjects were to receive once weekly subcutaneous (s.c.) injection of 0.3 milligrams (mg) cagrilintide for 26 weeks, using NovoPen® 4 pen-injector.

    Reporting group title
    Cagrilintide 0.6 mg
    Reporting group description
    Subjects were to receive once weekly s.c. injection of 0.6 mg cagrilintide for 26 weeks, using NovoPen® 4 pen-injector.

    Reporting group title
    Cagrilintide 1.2 mg
    Reporting group description
    Subjects were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Subjects initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 1.2 mg was reached: 0.6 mg (week 0) and 1.2 mg (week 2 to week 26).

    Reporting group title
    Cagrilintide 2.4 mg
    Reporting group description
    Subjects were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Subjects initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 2.4 mg was reached: 0.6 mg (week 0), 1.2 mg (week 2), 2.4 mg (week 4 to week 26).

    Reporting group title
    Cagrilintide 4.5 mg
    Reporting group description
    Subjects were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Subjects initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 4.5 mg was reached: 0.6 mg (week 0), 1.2 mg (week 2), 2.4 mg (week 4), 4.5 mg (week 6 to week 26).

    Reporting group title
    Liraglutide 3.0 mg
    Reporting group description
    Subjects were to receive once daily s.c. injection of liraglutide for 26 weeks, using PDS290 pen-injector. Subjects initially received 0.6 mg of liraglutide and the dose was then escalated every week until the target dose of 3.0 mg was reached: 0.6 mg (week 0), 1.2 mg (week 1), 1.8 mg (week 2), 2.4 mg (week 3), 3.0 mg (week 4 to week 26).

    Reporting group title
    Pooled placebo
    Reporting group description
    Subjects were to receive once weekly / once daily s.c. injection of placebo matched to cagrilintide / liraglutide (0.3 mg, 0.6 mg, 1.2 mg, 2.4 mg or 4.5 mg / 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, 3.0 mg ) for 26 weeks respectively.

    Primary: Change in body weight (%)

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    End point title
    Change in body weight (%)
    End point description
    Change in body weight (%) from week 0 to week 26 is presented. For descriptive analysis and statistical analysis endpoint was evaluated based on data from in-trial period and treatment adherent period, respectively. In-trial period was defined as uninterrupted time interval from date of randomisation to date of last contact with trial site. Follow-up time for positive antibodies was not included in in-trial period. Treatment-adherent: a subject is treatment adherent until first time of non-adherence defined as: subject has not been dosed with trial product within the prior 14 days; subject has received other weight management drug or bariatric surgery; subject has not reached target dose at a pre-specified week; After the pre-specified evaluation week for the target dose, subject has not received the target dose ±10% within the prior 14 days. The full analysis set included all randomised subjects. Number of subjects analysed = Number of subjects who contributed to the analysis.
    End point type
    Primary
    End point timeframe
    From randomization at week 0 to week 26
    End point values
    Cagrilintide 0.3 mg Cagrilintide 0.6 mg Cagrilintide 1.2 mg Cagrilintide 2.4 mg Cagrilintide 4.5 mg Liraglutide 3.0 mg Pooled placebo
    Number of subjects analysed
    96
    97
    98
    99
    97
    95
    95
    Units: Percentage point of body weight
        arithmetic mean (standard deviation)
    -6.1 ( 3.9 )
    -6.9 ( 5.4 )
    -8.5 ( 5.4 )
    -9.5 ( 6.2 )
    -10.8 ( 5.5 )
    -8.5 ( 5.6 )
    -3.0 ( 5.2 )
    Statistical analysis title
    Cagrilintide 0.3 mg versus Placebo
    Statistical analysis description
    Week 26 responses were analysed using an analysis of covariance (ANCOVA) model with randomised treatment as factor and baseline (week 0) body weight as covariate. For each treatment arm, multiple (x1000) imputation of intermittend missing data was done using Markov Chain Monte Carlo, followed by sequential regression for monotone missing values of body weight including sex and region as factors.
    Comparison groups
    Cagrilintide 0.3 mg v Pooled placebo
    Number of subjects included in analysis
    191
    Analysis specification
    Pre-specified
    Analysis type
    superiority [1]
    P-value
    = 0.0002
    Method
    ANCOVA
    Parameter type
    Treatment difference (%-points)
    Point estimate
    -2.99
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -4.58
         upper limit
    -1.4
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.81
    Notes
    [1] - Erroneously, database auto-calculated the total number of subjects. The subjects in this analysis were 202.
    Statistical analysis title
    Cagrilintide 0.6 mg versus Placebo
    Statistical analysis description
    Week 26 responses were analysed using an analysis of covariance model with randomised treatment as factor and baseline (week 0) body weight as covariate. For each treatment arm, multiple (x1000) imputation of intermittend missing data was done using Markov Chain Monte Carlo, followed by sequential regression for monotone missing values of body weight including sex and region as factors.
    Comparison groups
    Cagrilintide 0.6 mg v Pooled placebo
    Number of subjects included in analysis
    192
    Analysis specification
    Pre-specified
    Analysis type
    superiority [2]
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    Treatment difference (%-points)
    Point estimate
    -3.78
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -5.38
         upper limit
    -2.17
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.82
    Notes
    [2] - Erroneously, database auto-calculated the total number of subjects. The subjects in this analysis were 201.
    Statistical analysis title
    Cagrilintide 1.2 mg versus Placebo
    Statistical analysis description
    Week 26 responses were analysed using an analysis of covariance model with randomised treatment as factor and baseline (week 0) body weight as covariate. For each treatment arm, multiple (x1000) imputation of intermittend missing data was done using Markov Chain Monte Carlo, followed by sequential regression for monotone missing values of body weight including sex and region as factors.
    Comparison groups
    Cagrilintide 1.2 mg v Pooled placebo
    Number of subjects included in analysis
    193
    Analysis specification
    Pre-specified
    Analysis type
    superiority [3]
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    Treatment difference (%-points)
    Point estimate
    -6.07
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -7.77
         upper limit
    -4.36
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.87
    Notes
    [3] - Erroneously, database auto-calculated the total number of subjects. The subjects in this analysis were 203.
    Statistical analysis title
    Cagrilintide 2.4 mg versus Placebo
    Statistical analysis description
    Week 26 responses were analysed using an analysis of covariance model with randomised treatment as factor and baseline (week 0) body weight as covariate. For each treatment arm, multiple (x1000) imputation of intermittend missing data was done using Markov Chain Monte Carlo, followed by sequential regression for monotone missing values of body weight including sex and region as factors.
    Comparison groups
    Cagrilintide 2.4 mg v Pooled placebo
    Number of subjects included in analysis
    194
    Analysis specification
    Pre-specified
    Analysis type
    superiority [4]
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    Treatment difference (%-points)
    Point estimate
    -6.68
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -8.28
         upper limit
    -5.09
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.81
    Notes
    [4] - Erroneously, database auto-calculated the total number of subjects. The subjects in this analysis were 203.
    Statistical analysis title
    Cagrilintide 4.5 mg versus Placebo
    Statistical analysis description
    Week 26 responses were analysed using an analysis of covariance model with randomised treatment as factor and baseline (week 0) body weight as covariate. For each treatment arm, multiple (x1000) imputation of intermittend missing data was done using Markov Chain Monte Carlo, followed by sequential regression for monotone missing values of body weight including sex and region as factors.
    Comparison groups
    Cagrilintide 4.5 mg v Pooled placebo
    Number of subjects included in analysis
    192
    Analysis specification
    Pre-specified
    Analysis type
    superiority [5]
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    Treatment difference (%-points)
    Point estimate
    -7.79
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -9.42
         upper limit
    -6.16
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.83
    Notes
    [5] - Erroneously, database auto-calculated the total number of subjects. The subjects in this analysis were 202.
    Statistical analysis title
    Liraglutide 3.0 mg versus Placebo
    Statistical analysis description
    Week 26 responses were analysed using an analysis of covariance model with randomised treatment as factor and baseline (week 0) body weight as covariate. For each treatment arm, multiple (x1000) imputation of intermittend missing data was done using Markov Chain Monte Carlo, followed by sequential regression for monotone missing values of body weight including sex and region as factors.
    Comparison groups
    Liraglutide 3.0 mg v Pooled placebo
    Number of subjects included in analysis
    190
    Analysis specification
    Pre-specified
    Analysis type
    superiority [6]
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    Treatment difference (%-points)
    Point estimate
    -5.98
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -7.61
         upper limit
    -4.35
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.83
    Notes
    [6] - Erroneously, database auto-calculated the total number of subjects. The subjects in this analysis were 200.
    Statistical analysis title
    Cagrilintide 0.3 mg Versus Liraglutide 3.0 mg
    Statistical analysis description
    Week 26 responses were analysed using an analysis of covariance model with randomised treatment as factor and baseline (week 0) body weight as covariate. For each treatment arm, multiple (x1000) imputation of intermittend missing data was done using Markov Chain Monte Carlo, followed by sequential regression for monotone missing values of body weight including sex and region as factors.
    Comparison groups
    Cagrilintide 0.3 mg v Liraglutide 3.0 mg
    Number of subjects included in analysis
    191
    Analysis specification
    Pre-specified
    Analysis type
    superiority [7]
    P-value
    = 0.0003
    Method
    ANCOVA
    Parameter type
    Treatment difference (%-points)
    Point estimate
    2.99
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.38
         upper limit
    4.6
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.82
    Notes
    [7] - Erroneously, database auto-calculated the total number of subjects. The subjects in this analysis were 200.
    Statistical analysis title
    Cagrilintide 0.6 mg Versus Liraglutide 3.0 mg
    Statistical analysis description
    Week 26 responses were analysed using an analysis of covariance model with randomised treatment as factor and baseline (week 0) body weight as covariate. For each treatment arm, multiple (x1000) imputation of intermittend missing data was done using Markov Chain Monte Carlo, followed by sequential regression for monotone missing values of body weight including sex and region as factors.
    Comparison groups
    Cagrilintide 0.6 mg v Liraglutide 3.0 mg
    Number of subjects included in analysis
    192
    Analysis specification
    Pre-specified
    Analysis type
    superiority [8]
    P-value
    = 0.0082
    Method
    ANCOVA
    Parameter type
    Treatment difference (%-points)
    Point estimate
    2.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.57
         upper limit
    3.84
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.83
    Notes
    [8] - Erroneously, database auto-calculated the total number of subjects. The subjects in this analysis were 199.
    Statistical analysis title
    Cagrilintide 1.2 mg Versus Liraglutide 3.0 mg
    Statistical analysis description
    Week 26 responses were analysed using an analysis of covariance model with randomised treatment as factor and baseline (week 0) body weight as covariate. For each treatment arm, multiple (x1000) imputation of intermittend missing data was done using Markov Chain Monte Carlo, followed by sequential regression for monotone missing values of body weight including sex and region as factors.
    Comparison groups
    Cagrilintide 1.2 mg v Liraglutide 3.0 mg
    Number of subjects included in analysis
    193
    Analysis specification
    Pre-specified
    Analysis type
    superiority [9]
    P-value
    = 0.9209
    Method
    ANCOVA
    Parameter type
    Treatment difference (%-points)
    Point estimate
    -0.09
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.82
         upper limit
    1.64
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.88
    Notes
    [9] - Erroneously, database auto-calculated the total number of subjects. The subjects in this analysis were 201.
    Statistical analysis title
    Cagrilintide 2.4 mg Versus Liraglutide 3.0 mg
    Statistical analysis description
    Week 26 responses were analysed using an analysis of covariance model with randomised treatment as factor and baseline (week 0) body weight as covariate. For each treatment arm, multiple (x1000) imputation of intermittend missing data was done using Markov Chain Monte Carlo, followed by sequential regression for monotone missing values of body weight including sex and region as factors.
    Comparison groups
    Cagrilintide 2.4 mg v Liraglutide 3.0 mg
    Number of subjects included in analysis
    194
    Analysis specification
    Pre-specified
    Analysis type
    superiority [10]
    P-value
    = 0.396
    Method
    ANCOVA
    Parameter type
    Treatment difference (%-points)
    Point estimate
    -0.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.33
         upper limit
    0.92
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.83
    Notes
    [10] - Erroneously, database auto-calculated the total number of subjects. The subjects in this analysis were 201.
    Statistical analysis title
    Cagrilintide 4.5 mg Verus Liraglutide 3.0 mg
    Statistical analysis description
    Week 26 responses were analysed using an analysis of covariance model with randomised treatment as factor and baseline (week 0) body weight as covariate. For each treatment arm, multiple (x1000) imputation of intermittend missing data was done using Markov Chain Monte Carlo, followed by sequential regression for monotone missing values of body weight including sex and region as factors.
    Comparison groups
    Cagrilintide 4.5 mg v Liraglutide 3.0 mg
    Number of subjects included in analysis
    192
    Analysis specification
    Pre-specified
    Analysis type
    superiority [11]
    P-value
    = 0.0316
    Method
    ANCOVA
    Parameter type
    Treatment difference (%-points)
    Point estimate
    -1.81
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -3.46
         upper limit
    -0.16
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.84
    Notes
    [11] - Erroneously, database auto-calculated the total number of subjects. The subjects in this analysis were 200.

    Secondary: Subjects who achieve (yes/no) body weight reduction more than or equal to 5% from randomisation

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    End point title
    Subjects who achieve (yes/no) body weight reduction more than or equal to 5% from randomisation
    End point description
    Percentage of subjects who achieved a weight loss of greater than or equal to (≥) 5% of baseline (week 0) body weight at 26 weeks is presented. The full analysis set included all randomised participants. Number of subjects analysed = Number of subjects who contributed to the analysis.
    End point type
    Secondary
    End point timeframe
    After 26 weeks
    End point values
    Cagrilintide 0.3 mg Cagrilintide 0.6 mg Cagrilintide 1.2 mg Cagrilintide 2.4 mg Cagrilintide 4.5 mg Liraglutide 3.0 mg Pooled placebo
    Number of subjects analysed
    83
    82
    72
    80
    80
    78
    79
    Units: Percentage of subjects
        number (not applicable)
    57.47
    61.98
    75.84
    74.12
    88.74
    76.16
    30.90
    No statistical analyses for this end point

    Secondary: Change in HbA1c (%-point)

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    End point title
    Change in HbA1c (%-point)
    End point description
    Change in HbA1c (measured as percentage point of HbA1c) from week 0 to week 26 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Follow-up time for positive antibodies was not included in the in-trial period. The full analysis set included all randomised subjects. Number of subjects analysed = Number of subjects who contributed to the analysis.
    End point type
    Secondary
    End point timeframe
    From randomization at week 0 to week 26
    End point values
    Cagrilintide 0.3 mg Cagrilintide 0.6 mg Cagrilintide 1.2 mg Cagrilintide 2.4 mg Cagrilintide 4.5 mg Liraglutide 3.0 mg Pooled placebo
    Number of subjects analysed
    93
    97
    95
    99
    95
    95
    94
    Units: Percentage point of HbA1c
        arithmetic mean (standard deviation)
    0.0 ( 0.2 )
    -0.1 ( 0.2 )
    -0.1 ( 0.3 )
    -0.1 ( 0.3 )
    -0.1 ( 0.2 )
    -0.3 ( 0.2 )
    -0.1 ( 0.2 )
    No statistical analyses for this end point

    Secondary: Change in HbA1c (mmol/mol)

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    End point title
    Change in HbA1c (mmol/mol)
    End point description
    Change in HbA1c from week 0 to week 26 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Follow-up time for positive antibodies was not included in the in-trial period. The full analysis set included all randomised subjects. Number of subjects analysed = Number of subjects who contributed to the analysis.
    End point type
    Secondary
    End point timeframe
    From randomization at week 0 to week 26
    End point values
    Cagrilintide 0.3 mg Cagrilintide 0.6 mg Cagrilintide 1.2 mg Cagrilintide 2.4 mg Cagrilintide 4.5 mg Liraglutide 3.0 mg Pooled placebo
    Number of subjects analysed
    93
    97
    95
    99
    95
    95
    94
    Units: millimoles per mole (mmol/mol)
        arithmetic mean (standard deviation)
    -0.5 ( 2.4 )
    -0.6 ( 2.2 )
    -0.8 ( 3.0 )
    -1.0 ( 2.9 )
    -1.2 ( 2.4 )
    -2.9 ( 2.7 )
    -0.6 ( 2.7 )
    No statistical analyses for this end point

    Secondary: Number of treatment emergent adverse events (TEAEs)

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    End point title
    Number of treatment emergent adverse events (TEAEs)
    End point description
    An adverse event (AE) was any untoward medical occurrence in a clinical trial participant administered or used a medicinal product, whether or not considered related to the medicinal product or usage. All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The endpoint was evaluated based on the data from on-treatment period which started from the date of first trial product administration to date of last trial product administration excluding potential off-treatment time intervals triggered by at least 6 consecutive missed doses for cagrilintide or 6 consecutive weeks of missed dosing with liraglutide. The safety analysis set included all randomized subjects exposed to at least one dose of randomized treatment.
    End point type
    Secondary
    End point timeframe
    From randomisation at week 0 to week 32 (‘end of trial’)
    End point values
    Cagrilintide 0.3 mg Cagrilintide 0.6 mg Cagrilintide 1.2 mg Cagrilintide 2.4 mg Cagrilintide 4.5 mg Liraglutide 3.0 mg Pooled placebo
    Number of subjects analysed
    101
    100
    102
    102
    101
    99
    101
    Units: Events
    335
    291
    361
    449
    460
    470
    276
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From week 0 to week 32 Results are based on the safety analysis set which included all randomised subjects exposed to at least one dose of randomised treatment. All presented adverse events are treatment emergent adverse events (TEAEs).
    Adverse event reporting additional description
    TEAE is defined as an event that had onset during on-treatment period which started from date of first trial product administration to date of last trial product administration excluding potential off-treatment time intervals triggered by at least 6 consecutive missed doses for cagrilintide or 6 consecutive weeks of missed dosing with liraglutide.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    23
    Reporting groups
    Reporting group title
    Cagrilintide 1.2 mg
    Reporting group description
    Subjects were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Subjects initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 1.2 mg was reached: 0.6 mg (week 0) and 1.2 mg (week 2 to week 26).

    Reporting group title
    Cagrilintide 0.6 mg
    Reporting group description
    Subjects were to receive once weekly s.c. injection of 0.6 mg cagrilintide for 26 weeks, using NovoPen® 4 pen-injector.

    Reporting group title
    Cagrilintide 0.3 mg
    Reporting group description
    Subjects were to receive once weekly s.c. injection of 0.3 mg cagrilintide for 26 weeks, using NovoPen® 4 pen-injector.

    Reporting group title
    Liraglutide 3.0 mg
    Reporting group description
    Subjects were to receive once daily s.c. injection of liraglutide for 26 weeks, using PDS290 pen-injector. Subjects initially received 0.6 mg of liraglutide and the dose was then escalated every week until the target dose of 3.0 mg was reached: 0.6 mg (week 0), 1.2 mg (week 1), 1.8 mg (week 2), 2.4 mg (week 3), 3.0 mg (week 4 to week 26).

    Reporting group title
    Cagrilintide 4.5 mg
    Reporting group description
    Subjects were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Subjects initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 4.5 mg was reached: 0.6 mg (week 0), 1.2 mg (week 2), 2.4 mg (week 4), 4.5 mg (week 6 to week 26).

    Reporting group title
    Placebo Pool
    Reporting group description
    Subjects were to receive once weekly / once daily s.c. injection of placebo matched to cagrilintide / liraglutide (0.3 mg, 0.6 mg, 1.2 mg, 2.4 mg or 4.5 mg / 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, 3.0 mg ) for 26 weeks respectively.

    Reporting group title
    Cagrilintide 2.4 mg
    Reporting group description
    Subjects were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Subjects initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 2.4 mg was reached: 0.6 mg (week 0), 1.2 mg (week 2), 2.4 mg (week 4 to week 26).

    Serious adverse events
    Cagrilintide 1.2 mg Cagrilintide 0.6 mg Cagrilintide 0.3 mg Liraglutide 3.0 mg Cagrilintide 4.5 mg Placebo Pool Cagrilintide 2.4 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 102 (6.86%)
    2 / 100 (2.00%)
    6 / 101 (5.94%)
    4 / 99 (4.04%)
    4 / 101 (3.96%)
    3 / 101 (2.97%)
    3 / 102 (2.94%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Gallbladder adenoma
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 100 (0.00%)
    1 / 101 (0.99%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
    0 / 101 (0.00%)
    0 / 102 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Invasive ductal breast carcinoma
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 100 (0.00%)
    0 / 101 (0.00%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
    0 / 101 (0.00%)
    0 / 102 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rectal adenocarcinoma
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 100 (1.00%)
    0 / 101 (0.00%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
    0 / 101 (0.00%)
    0 / 102 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 100 (0.00%)
    0 / 101 (0.00%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
    0 / 101 (0.00%)
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 100 (0.00%)
    0 / 101 (0.00%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
    2 / 101 (1.98%)
    0 / 102 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 100 (0.00%)
    1 / 101 (0.99%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
    0 / 101 (0.00%)
    0 / 102 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 100 (0.00%)
    0 / 101 (0.00%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
    0 / 101 (0.00%)
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 100 (0.00%)
    0 / 101 (0.00%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
    0 / 101 (0.00%)
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 100 (0.00%)
    0 / 101 (0.00%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
    0 / 101 (0.00%)
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 100 (0.00%)
    0 / 101 (0.00%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
    0 / 101 (0.00%)
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 100 (0.00%)
    1 / 101 (0.99%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
    0 / 101 (0.00%)
    0 / 102 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Delirium
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 100 (0.00%)
    0 / 101 (0.00%)
    0 / 99 (0.00%)
    1 / 101 (0.99%)
    0 / 101 (0.00%)
    0 / 102 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Electrocardiogram QT prolonged
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 100 (0.00%)
    0 / 101 (0.00%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
    1 / 101 (0.99%)
    0 / 102 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Ligament injury
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 100 (1.00%)
    0 / 101 (0.00%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
    0 / 101 (0.00%)
    0 / 102 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Meniscus injury
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 100 (1.00%)
    0 / 101 (0.00%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
    0 / 101 (0.00%)
    0 / 102 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 100 (0.00%)
    0 / 101 (0.00%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
    0 / 101 (0.00%)
    0 / 102 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 100 (0.00%)
    1 / 101 (0.99%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
    0 / 101 (0.00%)
    0 / 102 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 100 (0.00%)
    0 / 101 (0.00%)
    1 / 99 (1.01%)
    0 / 101 (0.00%)
    0 / 101 (0.00%)
    0 / 102 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Deficiency anaemia
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 100 (0.00%)
    1 / 101 (0.99%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
    0 / 101 (0.00%)
    0 / 102 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Retinal detachment
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 100 (0.00%)
    1 / 101 (0.99%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
    0 / 101 (0.00%)
    0 / 102 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal hernia
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 100 (0.00%)
    0 / 101 (0.00%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
    0 / 101 (0.00%)
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Duodenal ulcer haemorrhage
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 100 (0.00%)
    1 / 101 (0.99%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
    0 / 101 (0.00%)
    0 / 102 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 100 (0.00%)
    0 / 101 (0.00%)
    1 / 99 (1.01%)
    0 / 101 (0.00%)
    0 / 101 (0.00%)
    0 / 102 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Biliary colic
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 100 (0.00%)
    0 / 101 (0.00%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
    0 / 101 (0.00%)
    0 / 102 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 100 (0.00%)
    0 / 101 (0.00%)
    1 / 99 (1.01%)
    1 / 101 (0.99%)
    0 / 101 (0.00%)
    0 / 102 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Chondrocalcinosis pyrophosphate
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 100 (0.00%)
    0 / 101 (0.00%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
    0 / 101 (0.00%)
    0 / 102 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intervertebral disc disorder
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 100 (0.00%)
    0 / 101 (0.00%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
    0 / 101 (0.00%)
    0 / 102 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 100 (0.00%)
    0 / 101 (0.00%)
    1 / 99 (1.01%)
    0 / 101 (0.00%)
    0 / 101 (0.00%)
    0 / 102 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Arthritis bacterial
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 100 (0.00%)
    0 / 101 (0.00%)
    0 / 99 (0.00%)
    1 / 101 (0.99%)
    0 / 101 (0.00%)
    0 / 102 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Campylobacter gastroenteritis
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 100 (0.00%)
    1 / 101 (0.99%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
    0 / 101 (0.00%)
    0 / 102 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pilonidal cyst
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 100 (0.00%)
    0 / 101 (0.00%)
    0 / 99 (0.00%)
    1 / 101 (0.99%)
    0 / 101 (0.00%)
    0 / 102 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 100 (0.00%)
    0 / 101 (0.00%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
    0 / 101 (0.00%)
    0 / 102 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hypokalaemia
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 100 (0.00%)
    0 / 101 (0.00%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
    1 / 101 (0.99%)
    0 / 102 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Cagrilintide 1.2 mg Cagrilintide 0.6 mg Cagrilintide 0.3 mg Liraglutide 3.0 mg Cagrilintide 4.5 mg Placebo Pool Cagrilintide 2.4 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    72 / 102 (70.59%)
    58 / 100 (58.00%)
    59 / 101 (58.42%)
    65 / 99 (65.66%)
    76 / 101 (75.25%)
    45 / 101 (44.55%)
    62 / 102 (60.78%)
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    8 / 102 (7.84%)
    2 / 100 (2.00%)
    8 / 101 (7.92%)
    5 / 99 (5.05%)
    9 / 101 (8.91%)
    3 / 101 (2.97%)
    9 / 102 (8.82%)
         occurrences all number
    9
    2
    10
    11
    12
    7
    14
    Headache
         subjects affected / exposed
    11 / 102 (10.78%)
    5 / 100 (5.00%)
    10 / 101 (9.90%)
    13 / 99 (13.13%)
    7 / 101 (6.93%)
    12 / 101 (11.88%)
    11 / 102 (10.78%)
         occurrences all number
    13
    5
    15
    24
    10
    22
    17
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    8 / 102 (7.84%)
    5 / 100 (5.00%)
    8 / 101 (7.92%)
    8 / 99 (8.08%)
    20 / 101 (19.80%)
    3 / 101 (2.97%)
    10 / 102 (9.80%)
         occurrences all number
    9
    5
    8
    8
    21
    3
    12
    Injection site erythema
         subjects affected / exposed
    6 / 102 (5.88%)
    4 / 100 (4.00%)
    5 / 101 (4.95%)
    3 / 99 (3.03%)
    17 / 101 (16.83%)
    0 / 101 (0.00%)
    7 / 102 (6.86%)
         occurrences all number
    6
    5
    5
    3
    22
    0
    23
    Injection site pruritus
         subjects affected / exposed
    4 / 102 (3.92%)
    2 / 100 (2.00%)
    5 / 101 (4.95%)
    3 / 99 (3.03%)
    7 / 101 (6.93%)
    0 / 101 (0.00%)
    7 / 102 (6.86%)
         occurrences all number
    4
    2
    6
    3
    7
    0
    11
    Injection site rash
         subjects affected / exposed
    2 / 102 (1.96%)
    3 / 100 (3.00%)
    0 / 101 (0.00%)
    2 / 99 (2.02%)
    6 / 101 (5.94%)
    0 / 101 (0.00%)
    0 / 102 (0.00%)
         occurrences all number
    4
    3
    0
    2
    8
    0
    0
    Injection site reaction
         subjects affected / exposed
    7 / 102 (6.86%)
    4 / 100 (4.00%)
    4 / 101 (3.96%)
    1 / 99 (1.01%)
    10 / 101 (9.90%)
    0 / 101 (0.00%)
    12 / 102 (11.76%)
         occurrences all number
    30
    10
    26
    1
    39
    0
    44
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    2 / 102 (1.96%)
    1 / 100 (1.00%)
    3 / 101 (2.97%)
    5 / 99 (5.05%)
    2 / 101 (1.98%)
    2 / 101 (1.98%)
    6 / 102 (5.88%)
         occurrences all number
    2
    1
    3
    5
    2
    3
    7
    Abdominal pain
         subjects affected / exposed
    4 / 102 (3.92%)
    5 / 100 (5.00%)
    2 / 101 (1.98%)
    4 / 99 (4.04%)
    5 / 101 (4.95%)
    1 / 101 (0.99%)
    3 / 102 (2.94%)
         occurrences all number
    5
    5
    3
    4
    5
    1
    4
    Abdominal pain upper
         subjects affected / exposed
    6 / 102 (5.88%)
    1 / 100 (1.00%)
    2 / 101 (1.98%)
    7 / 99 (7.07%)
    2 / 101 (1.98%)
    3 / 101 (2.97%)
    4 / 102 (3.92%)
         occurrences all number
    6
    1
    2
    9
    2
    3
    4
    Constipation
         subjects affected / exposed
    8 / 102 (7.84%)
    9 / 100 (9.00%)
    11 / 101 (10.89%)
    26 / 99 (26.26%)
    21 / 101 (20.79%)
    7 / 101 (6.93%)
    17 / 102 (16.67%)
         occurrences all number
    8
    9
    12
    30
    25
    10
    17
    Diarrhoea
         subjects affected / exposed
    8 / 102 (7.84%)
    10 / 100 (10.00%)
    15 / 101 (14.85%)
    18 / 99 (18.18%)
    7 / 101 (6.93%)
    9 / 101 (8.91%)
    18 / 102 (17.65%)
         occurrences all number
    9
    12
    22
    28
    9
    10
    20
    Dry mouth
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 100 (0.00%)
    2 / 101 (1.98%)
    5 / 99 (5.05%)
    0 / 101 (0.00%)
    0 / 101 (0.00%)
    2 / 102 (1.96%)
         occurrences all number
    1
    0
    2
    6
    0
    0
    3
    Dyspepsia
         subjects affected / exposed
    3 / 102 (2.94%)
    2 / 100 (2.00%)
    3 / 101 (2.97%)
    10 / 99 (10.10%)
    4 / 101 (3.96%)
    4 / 101 (3.96%)
    3 / 102 (2.94%)
         occurrences all number
    3
    2
    4
    10
    4
    4
    3
    Nausea
         subjects affected / exposed
    37 / 102 (36.27%)
    27 / 100 (27.00%)
    20 / 101 (19.80%)
    39 / 99 (39.39%)
    47 / 101 (46.53%)
    18 / 101 (17.82%)
    32 / 102 (31.37%)
         occurrences all number
    45
    32
    26
    56
    61
    26
    41
    Vomiting
         subjects affected / exposed
    5 / 102 (4.90%)
    6 / 100 (6.00%)
    6 / 101 (5.94%)
    20 / 99 (20.20%)
    8 / 101 (7.92%)
    3 / 101 (2.97%)
    9 / 102 (8.82%)
         occurrences all number
    5
    7
    6
    31
    8
    4
    11
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    3 / 102 (2.94%)
    5 / 100 (5.00%)
    1 / 101 (0.99%)
    2 / 99 (2.02%)
    6 / 101 (5.94%)
    7 / 101 (6.93%)
    6 / 102 (5.88%)
         occurrences all number
    3
    6
    1
    4
    6
    8
    7
    Pain in extremity
         subjects affected / exposed
    2 / 102 (1.96%)
    2 / 100 (2.00%)
    0 / 101 (0.00%)
    2 / 99 (2.02%)
    1 / 101 (0.99%)
    7 / 101 (6.93%)
    1 / 102 (0.98%)
         occurrences all number
    2
    2
    0
    2
    1
    7
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    13 / 102 (12.75%)
    9 / 100 (9.00%)
    6 / 101 (5.94%)
    10 / 99 (10.10%)
    3 / 101 (2.97%)
    10 / 101 (9.90%)
    4 / 102 (3.92%)
         occurrences all number
    14
    12
    7
    12
    3
    12
    7
    Upper respiratory tract infection
         subjects affected / exposed
    6 / 102 (5.88%)
    3 / 100 (3.00%)
    4 / 101 (3.96%)
    7 / 99 (7.07%)
    6 / 101 (5.94%)
    3 / 101 (2.97%)
    2 / 102 (1.96%)
         occurrences all number
    7
    4
    5
    8
    7
    5
    2
    Urinary tract infection
         subjects affected / exposed
    3 / 102 (2.94%)
    7 / 100 (7.00%)
    1 / 101 (0.99%)
    4 / 99 (4.04%)
    2 / 101 (1.98%)
    2 / 101 (1.98%)
    4 / 102 (3.92%)
         occurrences all number
    3
    9
    1
    4
    2
    2
    5
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    8 / 102 (7.84%)
    9 / 100 (9.00%)
    4 / 101 (3.96%)
    9 / 99 (9.09%)
    17 / 101 (16.83%)
    4 / 101 (3.96%)
    13 / 102 (12.75%)
         occurrences all number
    8
    9
    4
    10
    18
    4
    13

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported

    Online references

    http://www.ncbi.nlm.nih.gov/pubmed/34798060
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