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    Clinical Trial Results:
    A randomized, subject- and investigator-blinded, placebo-controlled study to assess the safety, pharmacokinetics and efficacy of intravenous bimagrumab in overweight and obese patients with type 2 diabetes

    Summary
    EudraCT number
    2016-004124-26
    Trial protocol
    GB  
    Global end of trial date
    08 May 2019

    Results information
    Results version number
    v1(current)
    This version publication date
    23 May 2020
    First version publication date
    23 May 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CBYM338X2211
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03005288
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    CH-4002, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, Novartis.email@novartis.com
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, Novartis.email@novartis.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
    08 May 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    08 May 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the trial was to evaluate the treatment effect of bimagrumab on total body fat mass.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    01 Feb 2017
    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 Kingdom: 4
    Country: Number of subjects enrolled
    United States: 74
    Worldwide total number of subjects
    78
    EEA total number of subjects
    4
    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)
    54
    From 65 to 84 years
    24
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The study was completed as planned.

    Pre-assignment
    Screening details
    Particpants were randomized to the study at 1:1 ratio to receive BYM338 10 mg/kg or placebo.

    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
    Investigator, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    BYM338 10 mg/kg
    Arm description
    intravenous infusion every four weeks
    Arm type
    Experimental

    Investigational medicinal product name
    Bimagrumab
    Investigational medicinal product code
    BYM338
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Bimagrumab 10 mg/kg up to maximum 1200 mg, every 4 weeks (12 doses)

    Arm title
    Placebo
    Arm description
    intravenous infusion every four weeks
    Arm type
    Placebo

    Investigational medicinal product name
    N/A
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Placebo, every 4 weeks (12 doses)

    Number of subjects in period 1
    BYM338 10 mg/kg Placebo
    Started
    39
    39
    Safety analysis set
    37
    38
    Pharmacodynamics (PD) analysis set
    36
    36
    Completed
    27
    31
    Not completed
    12
    8
         Physician decision
    -
    1
         Adverse event, non-fatal
    5
    -
         Consent withdrawn by subject
    7
    5
         Protocol deviation
    -
    1
         Lost to follow-up
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    BYM338 10 mg/kg
    Reporting group description
    intravenous infusion every four weeks

    Reporting group title
    Placebo
    Reporting group description
    intravenous infusion every four weeks

    Reporting group values
    BYM338 10 mg/kg Placebo Total
    Number of subjects
    39 39 78
    Age categorical
    Units: Subjects
        In utero
    0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0
        Newborns (0-27 days)
    0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0
        Children (2-11 years)
    0 0 0
        Adolescents (12-17 years)
    0 0 0
        Adults (18-64 years)
    27 27 54
        From 65-84 years
    12 12 24
        85 years and over
    0 0 0
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    60.7 ± 7.50 60.2 ± 8.02 -
    Sex: Female, Male
    Units: participants
        Female
    23 13 36
        Male
    16 26 42
    Race/Ethnicity, Customized
    Units: Subjects
        Black Or African American
    6 9 15
        Other
    1 0 1
        White
    32 28 60
        Asian
    0 1 1
        Unknown
    0 1 1
    Race/Ethnicity, Customized
    Units: Subjects
        Hispanic Or Latino
    28 26 54
        Not Hispanic Or Latino
    10 12 22
        Not Reported
    1 1 2

    End points

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    End points reporting groups
    Reporting group title
    BYM338 10 mg/kg
    Reporting group description
    intravenous infusion every four weeks

    Reporting group title
    Placebo
    Reporting group description
    intravenous infusion every four weeks

    Primary: Change from baseline in total body fat mass by Dual energy X-ray absorptiometry (DXA) at week 48

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    End point title
    Change from baseline in total body fat mass by Dual energy X-ray absorptiometry (DXA) at week 48
    End point description
    Dual energy X-ray absorptiometry (DXA) was used to assess changes in body composition, including total fat and lean body mass (FM and LBM) and appendicular skeletal fat and muscle mass (aFM and aLBM). DXA instruments had a source that generated x-rays split into two energies which measured bone mineral mass and soft tissue from which fat and fat-free mass (or lean body mass) were estimated.
    End point type
    Primary
    End point timeframe
    Baseline, Week 48
    End point values
    BYM338 10 mg/kg Placebo
    Number of subjects analysed
    36
    36
    Units: kg
        least squares mean (confidence interval 80%)
    -7.49 (-8.33 to -6.64)
    -0.18 (-0.99 to 0.63)
    Statistical analysis title
    Pharmacodynamic analysis set
    Comparison groups
    BYM338 10 mg/kg v Placebo
    Number of subjects included in analysis
    72
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Mixed-Effect Model Repeated Measure
    Parameter type
    Mean difference (net)
    Point estimate
    -7.31
    Confidence interval
         level
    80%
         sides
    2-sided
         lower limit
    -8.48
         upper limit
    -6.14

    Secondary: Change from baseline in total body fat mass by Dual energy X-ray absorptiometry (DXA) at week 24

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    End point title
    Change from baseline in total body fat mass by Dual energy X-ray absorptiometry (DXA) at week 24
    End point description
    Dual energy X-ray absorptiometry (DXA) was used to assess changes in body composition, including total fat and lean body mass (FM and LBM) and appendicular skeletal fat and muscle mass (aFM and aLBM). DXA instruments had a source that generated x-rays split into two energies which measured bone mineral mass and soft tissue from which fat and fat-free mass (or lean body mass) were estimated.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24
    End point values
    BYM338 10 mg/kg Placebo
    Number of subjects analysed
    36
    36
    Units: kg
        least squares mean (confidence interval 80%)
    -5.37 (-5.96 to -4.78)
    -0.18 (-0.75 to 0.39)
    Statistical analysis title
    Pharmacodynamic analysis set
    Comparison groups
    BYM338 10 mg/kg v Placebo
    Number of subjects included in analysis
    72
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    < 0.001
    Method
    Mixed-Effect Model Repeated Measure
    Parameter type
    Mean difference (net)
    Point estimate
    -5.19
    Confidence interval
         level
    80%
         sides
    2-sided
         lower limit
    -6.01
         upper limit
    -4.37

    Secondary: Change from baseline in HbA1c at week 24 and 48

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    End point title
    Change from baseline in HbA1c at week 24 and 48
    End point description
    HbA1c reflects average glucose concentrations over the past 3 months and therefore provides a useful index of the glycemic control of bimagrumab over that time period. It is a standard endpoint used to assess the glycemic efficacy of any anti-diabetic medication. HbA1c is a key glycemic parameter which correlates with reduction of risk of diabetic complications.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24, Week 48
    End point values
    BYM338 10 mg/kg Placebo
    Number of subjects analysed
    36
    36
    Units: percentage change
    least squares mean (confidence interval 80%)
        week 24
    -0.85 (-1.06 to -0.64)
    0.28 (0.08 to 0.48)
        week 48
    -0.76 (-1.05 to -0.48)
    0.04 (-0.23 to 0.31)
    Statistical analysis title
    Pharmacodynamic analysis set
    Statistical analysis description
    week 24
    Comparison groups
    BYM338 10 mg/kg v Placebo
    Number of subjects included in analysis
    72
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    < 0.001
    Method
    Mixed models analysis
    Parameter type
    Mean difference (net)
    Point estimate
    -1.13
    Confidence interval
         level
    80%
         sides
    2-sided
         lower limit
    -1.42
         upper limit
    -0.83
    Statistical analysis title
    Pharmacodynamic analysis set
    Statistical analysis description
    week 48
    Comparison groups
    BYM338 10 mg/kg v Placebo
    Number of subjects included in analysis
    72
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.005
    Method
    Mixed models analysis
    Parameter type
    Mean difference (net)
    Point estimate
    -0.8
    Confidence interval
         level
    80%
         sides
    2-sided
         lower limit
    -1.2
         upper limit
    -0.41

    Secondary: The trough observed analyte concentration (Ctrough) of repeat doses of BYM338 10 mg/kg on day 84, 168, 252, 308 and 336

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    End point title
    The trough observed analyte concentration (Ctrough) of repeat doses of BYM338 10 mg/kg on day 84, 168, 252, 308 and 336
    End point description
    The trough observed analyte concentration (Ctrough) is the concentration that is just prior to the beginning of, or at the end of, a dosing interval (μg/mL).
    End point type
    Secondary
    End point timeframe
    Day 84, 168, 252, 308, 336
    End point values
    BYM338 10 mg/kg Placebo
    Number of subjects analysed
    36
    0 [1]
    Units: μg/mL
    arithmetic mean (standard deviation)
        Day 84
    25.3 ± 6.20
    ±
        Day 168
    27.5 ± 8.37
    ±
        Day 252
    31.0 ± 11.2
    ±
        Day 308
    29.9 ± 11.0
    ±
        Day 336
    27.8 ± 10.9
    ±
    Notes
    [1] - PK samples were only obtained and evaluated for subjects treated with BYM338
    No statistical analyses for this end point

    Secondary: Maximum Observed Serum Concentration(Cmax) derived on day 1, 168 and 308

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    End point title
    Maximum Observed Serum Concentration(Cmax) derived on day 1, 168 and 308
    End point description
    Cmax is the observed maximum plasma concentration following administration (μg/mL).
    End point type
    Secondary
    End point timeframe
    Day 1, 168, 308
    End point values
    BYM338 10 mg/kg Placebo
    Number of subjects analysed
    36
    0 [2]
    Units: μg/mL
    arithmetic mean (standard deviation)
        Day 1
    283 ± 32.0
    ±
        Day 168
    292 ± 45.3
    ±
        Day 308
    271 ± 31.1
    ±
    Notes
    [2] - PK samples were only obtained and evaluated for subjects treated with BYM338
    No statistical analyses for this end point

    Secondary: Time to Reach the Maximum Concentration after Drug Administration (Tmax) derived on day 168 and 308

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    End point title
    Time to Reach the Maximum Concentration after Drug Administration (Tmax) derived on day 168 and 308
    End point description
    Tmax is the time to reach peak or maximum concentration (h).
    End point type
    Secondary
    End point timeframe
    Day 1, 168, 308
    End point values
    BYM338 10 mg/kg Placebo
    Number of subjects analysed
    36
    0 [3]
    Units: hr
    median (inter-quartile range (Q1-Q3))
        Day 1
    0.750 (0.683 to 0.917)
    ( to )
        Day 168
    0.750 (0.750 to 1.05)
    ( to )
        Day 308
    0.750 (0.750 to 1.38)
    ( to )
    Notes
    [3] - PK samples were only obtained and evaluated for subjects treated with BYM338
    No statistical analyses for this end point

    Secondary: Change from baseline in Body Mass Index (BMI)

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    End point title
    Change from baseline in Body Mass Index (BMI)
    End point description
    Body Mass Index (BMI) was determined by height and weight measurements at week 24 and 48. A negative change from baseline indicates improvement. BMI was calculated as (Body weight (kg)/ [Height (m)]^).
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24, Week 48
    End point values
    BYM338 10 mg/kg Placebo
    Number of subjects analysed
    36
    36
    Units: Kg/m^2
    least squares mean (confidence interval 80%)
        week 24
    -1.50 (-1.77 to -1.23)
    -0.17 (-0.43 to 0.10)
        week 48
    -2.19 (-2.60 to -1.78)
    -0.28 (-0.67 to 0.11)
    Statistical analysis title
    Pharmacodynamic analysis set
    Statistical analysis description
    week 24
    Comparison groups
    BYM338 10 mg/kg v Placebo
    Number of subjects included in analysis
    72
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    < 0.001
    Method
    Mixed-Effect Model Repeated Measure
    Parameter type
    Mean difference (net)
    Point estimate
    -1.33
    Confidence interval
         level
    80%
         sides
    2-sided
         lower limit
    -1.71
         upper limit
    -0.95
    Statistical analysis title
    Pharmacodynamic analysis set
    Statistical analysis description
    week 48
    Comparison groups
    BYM338 10 mg/kg v Placebo
    Number of subjects included in analysis
    72
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    < 0.001
    Method
    Mixed-Effect Model Repeated Measure
    Parameter type
    Mean difference (net)
    Point estimate
    -1.91
    Confidence interval
         level
    80%
         sides
    2-sided
         lower limit
    -2.48
         upper limit
    -1.34

    Secondary: Change from baseline in weight

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    End point title
    Change from baseline in weight
    End point description
    Body weight was measured to the nearest 0.1 kilogram (kg) in indoor clothing without shoes. A negative change from baseline indicates improvement.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24, Week 48
    End point values
    BYM338 10 mg/kg Placebo
    Number of subjects analysed
    36
    36
    Units: Kg
    least squares mean (confidence interval 80%)
        week 24
    -3.99 (-4.79 to -3.19)
    -0.57 (-1.34 to 0.21)
        week 48
    -5.90 (-7.08 to -4.71)
    -0.79 (-1.92 to 0.33)
    Statistical analysis title
    Pharmacodynamic analysis set
    Statistical analysis description
    week 24
    Comparison groups
    BYM338 10 mg/kg v Placebo
    Number of subjects included in analysis
    72
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    < 0.001
    Method
    Mixed-Effect Model Repeated Measure
    Parameter type
    Mean difference (net)
    Point estimate
    -3.43
    Confidence interval
         level
    80%
         sides
    2-sided
         lower limit
    -4.54
         upper limit
    -2.31
    Statistical analysis title
    Pharmacodynamic analysis set
    Statistical analysis description
    week 48
    Comparison groups
    BYM338 10 mg/kg v Placebo
    Number of subjects included in analysis
    72
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    < 0.001
    Method
    Mixed-Effect Model Repeated Measure
    Parameter type
    Mean difference (net)
    Point estimate
    -5.1
    Confidence interval
         level
    80%
         sides
    2-sided
         lower limit
    -6.74
         upper limit
    -3.47

    Secondary: Change from baseline in lean body mass (LBM) measured by DXA

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    End point title
    Change from baseline in lean body mass (LBM) measured by DXA
    End point description
    Lean body mass (LBM) is a part of body composition defined as the difference between total body weight and body fat weight. This means that it counts the mass of all organs except body fat, including bones, muscles, blood, skin, and everything else. Dual energy X-ray absorptiometry (DXA) was used to assess changes in body composition, including total fat and lean body mass (FM and LBM) and appendicular skeletal fat and muscle mass (aFM and aLBM). DXA instruments had a source that generated x-rays split into two energies which measured bone mineral mass and soft tissue from which fat and fat-free mass (or lean body mass) were estimated.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24, Week 48
    End point values
    BYM338 10 mg/kg Placebo
    Number of subjects analysed
    36
    36
    Units: Kg
    least squares mean (confidence interval 80%)
        week 24
    1.72 (1.25 to 2.19)
    0.23 (-0.23 to 0.68)
        week 48
    1.70 (1.14 to 2.26)
    -0.44 (-0.97 to 0.09)
    Statistical analysis title
    Pharmacodynamic analysis set
    Statistical analysis description
    week 24
    Comparison groups
    BYM338 10 mg/kg v Placebo
    Number of subjects included in analysis
    72
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.003
    Method
    Mixed-Effect Model Repeated Measure
    Parameter type
    Mean difference (net)
    Point estimate
    1.49
    Confidence interval
         level
    80%
         sides
    2-sided
         lower limit
    0.82
         upper limit
    2.06
    Statistical analysis title
    Pharmacodynamic analysis set
    Statistical analysis description
    week 48
    Comparison groups
    BYM338 10 mg/kg v Placebo
    Number of subjects included in analysis
    72
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    < 0.001
    Method
    Mixed-Effect Model Repeated Measure
    Parameter type
    Mean difference (net)
    Point estimate
    2.14
    Confidence interval
         level
    80%
         sides
    2-sided
         lower limit
    1.36
         upper limit
    2.93

    Secondary: Change from baseline in waist circumference

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    End point title
    Change from baseline in waist circumference
    End point description
    Waist circumference is the length in cm of the circumference to the nearest 0.1 cm at the level of the umbilicus with the subject in the upright position. A negative change indicates improvement.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24, Week 52
    End point values
    BYM338 10 mg/kg Placebo
    Number of subjects analysed
    36
    36
    Units: cm
    least squares mean (confidence interval 80%)
        week 24
    -5.04 (-5.87 to -4.20)
    -0.95 (-1.75 to -0.14)
        week 52
    -9.00 (-10.3 to -7.68)
    0.45 (-0.79 to 1.69)
    Statistical analysis title
    Pharmacodynamic analysis set
    Statistical analysis description
    week 24
    Comparison groups
    BYM338 10 mg/kg v Placebo
    Number of subjects included in analysis
    72
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    < 0.001
    Method
    Mixed-Effect Model Repeated Measure
    Parameter type
    Mean difference (net)
    Point estimate
    -4.09
    Confidence interval
         level
    80%
         sides
    2-sided
         lower limit
    -5.26
         upper limit
    -2.92
    Statistical analysis title
    Pharmacodynamic analysis set
    Statistical analysis description
    week 52
    Comparison groups
    BYM338 10 mg/kg v Placebo
    Number of subjects included in analysis
    72
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    < 0.001
    Method
    Mixed-Effect Model Repeated Measure
    Parameter type
    Mean difference (net)
    Point estimate
    -9.46
    Confidence interval
         level
    80%
         sides
    2-sided
         lower limit
    -11.3
         upper limit
    -7.64

    Secondary: Change from baseline in waist to hip ratio

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    End point title
    Change from baseline in waist to hip ratio
    End point description
    Hip circumference was measured at the greatest protrusion of the buttocks. Combined with waist circumference, the waist-to-hip ratio was derived during data analysis.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24, Week 52
    End point values
    BYM338 10 mg/kg Placebo
    Number of subjects analysed
    36
    36
    Units: ratio
    least squares mean (confidence interval 80%)
        week 24
    -0.02 (-0.03 to -0.01)
    -0.01 (-0.01 to 0.00)
        week 52
    -0.05 (-0.06 to -0.04)
    0.01 (0.00 to 0.02)
    Statistical analysis title
    Pharmacodynamic analysis set
    Statistical analysis description
    week 24
    Comparison groups
    BYM338 10 mg/kg v Placebo
    Number of subjects included in analysis
    72
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.062
    Method
    Mixed-Effect Model Repeated Measure
    Parameter type
    Mean difference (net)
    Point estimate
    -0.02
    Confidence interval
         level
    80%
         sides
    2-sided
         lower limit
    -0.03
         upper limit
    0
    Statistical analysis title
    Pharmacodynamic analysis set
    Statistical analysis description
    week 52
    Comparison groups
    BYM338 10 mg/kg v Placebo
    Number of subjects included in analysis
    72
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    < 0.001
    Method
    Mixed-Effect Model Repeated Measure
    Parameter type
    Mean difference (net)
    Point estimate
    -0.06
    Confidence interval
         level
    80%
         sides
    2-sided
         lower limit
    -0.08
         upper limit
    -0.04

    Secondary: Change from baseline in insulin resistance (HOMA2-IR)

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    End point title
    Change from baseline in insulin resistance (HOMA2-IR)
    End point description
    Blood samples were collected to analyze insulin resistance. HOMA2-IR is a derived insulin resistance index that was calculated based on measures of serum glucose and insulin, using an online calculator.
    End point type
    Secondary
    End point timeframe
    Baseline. Week 12, Week 36
    End point values
    BYM338 10 mg/kg Placebo
    Number of subjects analysed
    36
    36
    Units: Insulin Resistance (IR) Score
    least squares mean (confidence interval 80%)
        week 12
    0.10 (-0.17 to 0.37)
    0.76 (0.50 to 1.02)
        week 36
    -0.09 (-0.44 to 0.25)
    0.57 (0.24 to 0.90)
    Statistical analysis title
    Pharmacodynamic analysis set
    Statistical analysis description
    week 12
    Comparison groups
    BYM338 10 mg/kg v Placebo
    Number of subjects included in analysis
    72
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.028
    Method
    Mixed-Effect Model Repeated Measure
    Parameter type
    Mean difference (net)
    Point estimate
    -0.65
    Confidence interval
         level
    80%
         sides
    2-sided
         lower limit
    -1.03
         upper limit
    -0.28
    Statistical analysis title
    Pharmacodynamic analysis set
    Statistical analysis description
    week 36
    Comparison groups
    BYM338 10 mg/kg v Placebo
    Number of subjects included in analysis
    72
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.081
    Method
    Mixed-Effect Model Repeated Measure
    Parameter type
    Mean difference (net)
    Point estimate
    -0.66
    Confidence interval
         level
    80%
         sides
    2-sided
         lower limit
    -1.14
         upper limit
    -0.18

    Secondary: Immunogenicity assessed by the number of participants developing anti-BYM338 antibodies during the trial

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    End point title
    Immunogenicity assessed by the number of participants developing anti-BYM338 antibodies during the trial
    End point description
    Describes the number of participants tested positive for anti-BYM338 antibodies after the start of bimagrumab (BYM338) treatment. A validated bridging enzyme-linked immunosorbent assay (ELISA) was used for the confirmation of the presence of anti-BYM338 antibodies in human serum.
    End point type
    Secondary
    End point timeframe
    392 days
    End point values
    BYM338 10 mg/kg Placebo
    Number of subjects analysed
    37
    38
    Units: participants
        Confirmed with positive immunogenicity
    2
    4
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were collected throughout the study for 56 weeks which includes the treatment period of 48 weeks and the follow-up period of 8 weeks.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    22.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Placebo

    Reporting group title
    BYM338 10 mg/kg
    Reporting group description
    BYM338 10 mg/kg

    Serious adverse events
    Placebo BYM338 10 mg/kg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 38 (7.89%)
    3 / 37 (8.11%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Thermal burn
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Lipase increased
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 37 (2.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute coronary syndrome
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute myocardial infarction
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 37 (2.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Impaired gastric emptying
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 37 (2.70%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 37 (2.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Placebo BYM338 10 mg/kg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    31 / 38 (81.58%)
    31 / 37 (83.78%)
    Vascular disorders
    Aortic stenosis
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 37 (0.00%)
         occurrences all number
    1
    0
    Hypertension
         subjects affected / exposed
    1 / 38 (2.63%)
    3 / 37 (8.11%)
         occurrences all number
    1
    3
    Phlebitis
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 37 (0.00%)
         occurrences all number
    1
    0
    Immune system disorders
    Allergy to arthropod bite
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 37 (0.00%)
         occurrences all number
    2
    0
    Food allergy
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 37 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 37 (0.00%)
         occurrences all number
    1
    0
    Chest pain
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    1
    Early satiety
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    1
    Fatigue
         subjects affected / exposed
    1 / 38 (2.63%)
    1 / 37 (2.70%)
         occurrences all number
    2
    1
    Influenza like illness
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 37 (0.00%)
         occurrences all number
    1
    0
    Infusion site extravasation
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 37 (0.00%)
         occurrences all number
    1
    0
    Non-cardiac chest pain
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 37 (0.00%)
         occurrences all number
    1
    0
    Pain
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    1
    Peripheral swelling
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 37 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 37 (0.00%)
         occurrences all number
    1
    0
    Insomnia
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 37 (0.00%)
         occurrences all number
    1
    0
    Nervousness
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 37 (0.00%)
         occurrences all number
    1
    0
    Reproductive system and breast disorders
    Menorrhagia
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    1
    Postmenopausal haemorrhage
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    1
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    1
    Ligament sprain
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 37 (0.00%)
         occurrences all number
    1
    0
    Craniocerebral injury
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    1
    Rib fracture
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 37 (0.00%)
         occurrences all number
    1
    0
    Skin laceration
         subjects affected / exposed
    2 / 38 (5.26%)
    0 / 37 (0.00%)
         occurrences all number
    2
    0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    1
    Amylase increased
         subjects affected / exposed
    0 / 38 (0.00%)
    2 / 37 (5.41%)
         occurrences all number
    0
    2
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    1
    Blood alkaline phosphatase increased
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    1
    Blood creatine phosphokinase MB increased
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 37 (0.00%)
         occurrences all number
    2
    0
    Blood creatine phosphokinase increased
         subjects affected / exposed
    1 / 38 (2.63%)
    1 / 37 (2.70%)
         occurrences all number
    1
    1
    Blood creatinine increased
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 37 (0.00%)
         occurrences all number
    1
    0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    1
    Lipase increased
         subjects affected / exposed
    2 / 38 (5.26%)
    4 / 37 (10.81%)
         occurrences all number
    2
    4
    Pancreatic enzymes increased
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    1
    Weight decreased
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 37 (0.00%)
         occurrences all number
    1
    0
    Weight increased
         subjects affected / exposed
    1 / 38 (2.63%)
    1 / 37 (2.70%)
         occurrences all number
    1
    1
    Cardiac disorders
    Bundle branch block right
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 37 (0.00%)
         occurrences all number
    1
    0
    Congenital, familial and genetic disorders
    Type V hyperlipidaemia
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    2 / 38 (5.26%)
    0 / 37 (0.00%)
         occurrences all number
    2
    0
    Dyspnoea exertional
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 37 (0.00%)
         occurrences all number
    1
    0
    Epistaxis
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    1
    Sinus congestion
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 38 (0.00%)
    3 / 37 (8.11%)
         occurrences all number
    0
    3
    Nervous system disorders
    Cognitive disorder
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 37 (0.00%)
         occurrences all number
    1
    0
    Dizziness
         subjects affected / exposed
    2 / 38 (5.26%)
    0 / 37 (0.00%)
         occurrences all number
    2
    0
    Dysgeusia
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    1
    Headache
         subjects affected / exposed
    5 / 38 (13.16%)
    0 / 37 (0.00%)
         occurrences all number
    9
    0
    Paraesthesia
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 37 (0.00%)
         occurrences all number
    1
    0
    Sciatica
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    1
    Syncope
         subjects affected / exposed
    0 / 38 (0.00%)
    2 / 37 (5.41%)
         occurrences all number
    0
    3
    Eye disorders
    Cataract
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    1
    Diabetic retinopathy
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    1
    Macular oedema
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    1
    Ear and labyrinth disorders
    Vertigo positional
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 37 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 38 (2.63%)
    2 / 37 (5.41%)
         occurrences all number
    1
    2
    Abdominal pain upper
         subjects affected / exposed
    2 / 38 (5.26%)
    0 / 37 (0.00%)
         occurrences all number
    2
    0
    Diarrhoea
         subjects affected / exposed
    4 / 38 (10.53%)
    15 / 37 (40.54%)
         occurrences all number
    6
    17
    Dyspepsia
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    1
    Frequent bowel movements
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    1
    Nausea
         subjects affected / exposed
    0 / 38 (0.00%)
    4 / 37 (10.81%)
         occurrences all number
    0
    5
    Tooth impacted
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    1
    Toothache
         subjects affected / exposed
    2 / 38 (5.26%)
    0 / 37 (0.00%)
         occurrences all number
    2
    0
    Vomiting
         subjects affected / exposed
    1 / 38 (2.63%)
    2 / 37 (5.41%)
         occurrences all number
    1
    2
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    1
    Chromaturia
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 37 (0.00%)
         occurrences all number
    1
    0
    Dysuria
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 37 (0.00%)
         occurrences all number
    1
    0
    Nephrolithiasis
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    1
    Proteinuria
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    1
    Renal cyst
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 37 (0.00%)
         occurrences all number
    1
    0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    1
    Hepatic steatosis
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 37 (0.00%)
         occurrences all number
    1
    0
    Hepatomegaly
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    1
    Alopecia
         subjects affected / exposed
    2 / 38 (5.26%)
    0 / 37 (0.00%)
         occurrences all number
    2
    0
    Blister
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    2
    Dermatitis
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 37 (0.00%)
         occurrences all number
    1
    0
    Ecchymosis
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 37 (0.00%)
         occurrences all number
    1
    0
    Rash
         subjects affected / exposed
    2 / 38 (5.26%)
    2 / 37 (5.41%)
         occurrences all number
    2
    2
    Skin ulcer
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 37 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 38 (5.26%)
    1 / 37 (2.70%)
         occurrences all number
    2
    1
    Coccydynia
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 37 (0.00%)
         occurrences all number
    1
    0
    Back pain
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 37 (0.00%)
         occurrences all number
    2
    0
    Muscle fatigue
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    2
    Muscle spasms
         subjects affected / exposed
    1 / 38 (2.63%)
    15 / 37 (40.54%)
         occurrences all number
    1
    23
    Muscle twitching
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 37 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal stiffness
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    1
    Myalgia
         subjects affected / exposed
    3 / 38 (7.89%)
    0 / 37 (0.00%)
         occurrences all number
    3
    0
    Neck mass
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    1
    Pain in extremity
         subjects affected / exposed
    2 / 38 (5.26%)
    0 / 37 (0.00%)
         occurrences all number
    3
    0
    Plantar fasciitis
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    1
    Tendonitis
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 37 (0.00%)
         occurrences all number
    1
    0
    Endocrine disorders
    Thyroid cyst
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    1
    Thyroid mass
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 38 (2.63%)
    2 / 37 (5.41%)
         occurrences all number
    1
    2
    Diabetes mellitus
         subjects affected / exposed
    1 / 38 (2.63%)
    1 / 37 (2.70%)
         occurrences all number
    1
    1
    Dehydration
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    1
    Hyperglycaemia
         subjects affected / exposed
    2 / 38 (5.26%)
    1 / 37 (2.70%)
         occurrences all number
    2
    1
    Hypoglycaemia
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 37 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Folliculitis
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 37 (0.00%)
         occurrences all number
    1
    0
    Bronchitis
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    1
    Gastroenteritis
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 37 (0.00%)
         occurrences all number
    1
    0
    Helicobacter infection
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    1
    Hordeolum
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    1
    Pharyngitis
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    1
    Influenza
         subjects affected / exposed
    0 / 38 (0.00%)
    2 / 37 (5.41%)
         occurrences all number
    0
    2
    Pneumonia
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 37 (0.00%)
         occurrences all number
    1
    0
    Rhinitis
         subjects affected / exposed
    2 / 38 (5.26%)
    0 / 37 (0.00%)
         occurrences all number
    2
    0
    Sialoadenitis
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    1
    Sinusitis
         subjects affected / exposed
    1 / 38 (2.63%)
    1 / 37 (2.70%)
         occurrences all number
    1
    1
    Tooth abscess
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 37 (0.00%)
         occurrences all number
    1
    0
    Tooth infection
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 37 (0.00%)
         occurrences all number
    1
    0
    Upper respiratory tract infection
         subjects affected / exposed
    5 / 38 (13.16%)
    6 / 37 (16.22%)
         occurrences all number
    5
    6
    Urinary tract infection
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    1
    Viral infection
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 37 (0.00%)
         occurrences all number
    1
    0
    Urinary tract infection fungal
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 37 (0.00%)
         occurrences all number
    1
    0
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 37 (2.70%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    23 Mar 2017
    Amendment 01: The purposes of this amendment were to: 1) align the study design with contemporary techniques for assessing dietary intake, physical activity, and insulin resistance; 2) integrate new safety data from recently completed bimagrumab studies; and 3) clarify the dietary intervention and overall assessment components of the study. At the time of this protocol amendment, no subjects were enrolled in the clinical study.
    26 Oct 2017
    Amendment 02: The primary purpose of this amendment was to present a new safety observation (transient elevations in lipase and amylase) in the bimagrumab development program and the resultant modifications to this protocol, to clarify language about laboratory evaluations required during the screening period, and to update eligibility criteria.
    23 Nov 2017
    Amendment 03: The primary purpose of this amendment was to include time points for the additional pancreatic enzyme safety monitoring that were inadvertently omitted from protocol amendment 02 and to clarify language related to treatment of adverse events and laboratory values.
    12 Mar 2018
    Amendment 04: The primary purpose of this amendment was to update the language related to the planned interim analyses and total sample size. More specifically:  Interim Analysis #1 was removed as it was no longer needed for decision making.  The assumed dropout rate was increased to 30% to reflect actual rate observed in the study, which increased the sample size to approximately 68 recruited. Additionally, this study began review by the program-level external Data Monitoring Committee (DMC).
    17 Jan 2019
    Amendment 05: The primary purpose of this amendment was to add an additional MRI at week 48 for subjects who had provided consent to this optional scan. Based on the results from the IA conducted after more than 50% of subjects had completed 24 weeks of treatment, this additional MRI scan was added to explore the effect of bimagrumab on MRI efficacy endpoints after 12 monthly doses.

    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
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
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