Obese, Obesity, Overweight or Obesity
Conditions
Keywords
bimagrumab, semaglutide
Brief summary
A phase 2 study to assess the efficacy of bimagrumab alone or in addition to semaglutide to assess efficacy and safety in overweight or obese men and women
Detailed description
This study investigates if bimagrumab in addition to semaglutide is able to preserve/increase muscle mass in the presence of weight and/or fat mass loss.
Interventions
BIOLOGICALBimagrumab
Human monoclonal antibody to the activin receptor type II
DRUGSemaglutide
Glucagon-like peptide-1 (GLP-1) receptor agonist
OTHERPlacebo
Placebo
Sponsors
Eli Lilly and Company
Versanis Bio, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
In regard to bimagrumab and placebo-bimagrumab, the participants, Investigator and Sponsor will be blinded. Due to semaglutide being pre-filled, packaged and labeled by manufacturer, it is not possible to blind semaglutide.
Intervention model description
The study is designed to have three periods. The 48-week core treatment period has 9 treatment arms, with combinations of 3 semaglutide doses (none, 1.0 mg and 2.4 mg) and 3 bimagrumab doses (0, 10 and 30 mg/kg). The core treatment period is then followed by an open-label 24-week treatment extension period during which participants originally assigned to either placebo or bimagrumab 10 mg/kg will switch to bimagrumab 30 mg/kg. All other treatment assignments will remain the same. The extension period is then followed by a 32-week post-treatment period, during which all study treatments will be withdrawn from all arms.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * A written informed consent must be obtained before any study-related assessments are performed. * Men and women between 18 and 80 years, inclusive; women of child-bearing potential (defined as those who are not post-menopausal or post-surgical sterilization) must meet both of the following criteria: * Two negative pregnancy tests (at screening and at randomization, prior to dosing) * Use of intrauterine device, from at least 3 months before the baseline visit through at least 4 months after the last dose of bimagrumab/placebo i.v., and an additional contraceptive (barrier) method from screening through at least 4 months after the last dose of bimagrumab/placebo i.v. * Body mass index (BMI) ≥ 30 or BMI ≥ 27 with one or more obesity-associated comorbidities (e.g., hypertension, insulin resistance, sleep apnea, or dyslipidemia) * Stable body weight (± 5 kg) within 90 days of screening, and body weight \<150 kg * Have a history of at least one self-reported unsuccessful behavioral effort to lose body weight * Able to communicate well with the Investigator, comply with the study requirements and adhere to the diet and activity programs for the study duration Key
Exclusion criteria
* History of, or known hypersensitivity to, monoclonal antibody drugs or a contraindication to semaglutide (Ozempic® or Wegovy®) * Use of other investigational drugs at the time of enrollment or within 30 days or 5 half-lives of enrollment, whichever is longer, or longer if required by local regulations * Treatment with any medication for the indication of obesity within the past 30 days before screening * Diagnosis of diabetes requiring current use of any antidiabetic drug or HbA1c ≥ 6.5% Note: Metabolic syndrome is not an exclusion, even if managed with an anti-diabetic drug such as metformin or an SGLT2 inhibitor. A diagnosis of prediabetes or impaired glucose tolerance managed exclusively with non-pharmacologic approaches (e.g., diet and exercise) is not an exclusion. * Any chronic infections likely to interfere with study conduct or interpretation such as hepatitis B (HBV), hepatitis C (HCV), or human immunodeficiency virus (HIV). History of hepatitis A or hepatitis C successfully treated is not exclusionary. Active COVID-19 infection. * Donation or loss of 400 mL or more of blood within 8 weeks prior to initial dosing, or longer if required by local regulation, or plasma donation (\> 250 mL) within 14 days prior to the first dose * Any disorder, unwillingness, or inability not covered by any of the other
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Body Weight at Week 48 | Baseline, Week 48 | Least Square mean was determined by MMRM model for post-baseline measures: Variable is modelled by Gender (Male, Female), Country (Australia, New Zealand, United States of America), Visit, Treatment, and Visit-by-Treatment interaction as fixed effects, and Baseline as a covariate. Variance-Covariance structure= Unstructured. Only participants with non-missing baseline value were included in analysis. No imputation was performed for missing values. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Waist Circumference at Week 48 | Baseline, Week 48 | Waist circumference was measured in standing position with a non-stretchable measuring tape to the nearest 0.1 centimeter (cm). Least Square mean was determined by mixed model repeated measures (MMRM) model for post-baseline measures: Variable is modelled by Gender (Male, Female), Country (Australia, New Zealand, United States of America), Visit, Treatment, and Visit-by-Treatment interaction as fixed effects, and Baseline as a covariate. Variance-Covariance structure= Unstructured. Only participants with non-missing baseline value were included in analysis. No imputation was performed for missing values. |
| Change From Baseline in Waist Circumference at Week 72 | Baseline, Week 72 | Waist circumference was measured in standing position with a non-stretchable measuring tape to the nearest 0.1 cm. Least Square mean was determined by mixed model repeated measures (MMRM) model for post-baseline measures: Variable is modelled by Gender (Male, Female), Country (Australia, New Zealand, United States of America), Visit, Treatment, and Visit-by-Treatment interaction as fixed effects, and Baseline as a covariate. Variance-Covariance structure= Unstructured. Only participants with non-missing baseline value were included in analysis. No imputation was performed for missing values. |
| Change From Baseline in Total Body Fat Mass in Kilograms (kg) at Week 48 | Baseline, Week 48 | Change from baseline in total body fat mass in kg was assessed by Dual energy X-ray absorptiometry (DXA). Least Square mean was determined by mixed model repeated measures (MMRM) model for post-baseline measures: Variable is modelled by Gender (Male, Female), Country (Australia, New Zealand, United States of America), Visit, Treatment, and Visit-by-Treatment interaction as fixed effects, and Baseline as a covariate. Variance-Covariance structure= Unstructured. Only participants with non-missing baseline value were included in analysis. No imputation was performed for missing values. |
| Change From Baseline in Total Body Fat Mass in kg at Week 72 | Baseline, Week 72 | Change from baseline in total body fat mass in kg was assessed by DXA. Least Square mean was determined by mixed model repeated measures (MMRM) model for post-baseline measures: Variable is modelled by Gender (Male, Female), Country (Australia, New Zealand, United States of America), Visit, Treatment, and Visit-by-Treatment interaction as fixed effects, and Baseline as a covariate. Variance-Covariance structure= Unstructured. Only participants with non-missing baseline value were included in analysis. No imputation was performed for missing values. |
| Percent Change From Baseline for Fat Mass by DXA at Week 48 | Baseline, Week 48 | Percent change from baseline for fat mass was assessed by DXA. Least Square mean was determined by MMRM model for post-baseline measures: Variable is modelled by Gender (Male, Female), Country (Australia, New Zealand, United States of America), Visit, Treatment, and Visit-by-Treatment interaction as fixed effects, and Baseline as a covariate. Variance-Covariance structure= Unstructured. Only participants with non-missing baseline value were included in analysis. No imputation was performed for missing values. |
| Percent Change From Baseline for Fat Mass by DXA at Week 72 | Baseline, Week 72 | Percent change from baseline for fat mass was assessed by DXA. Least Square mean was determined by MMRM model for post-baseline measures: Variable is modelled by Gender (Male, Female), Country (Australia, New Zealand, United States of America), Visit, Treatment, and Visit-by-Treatment interaction as fixed effects, and Baseline as a covariate. Variance-Covariance structure= Unstructured. Only participants with non-missing baseline value were included in analysis. No imputation was performed for missing values. |
| Change From Baseline in Visceral Adipose Tissue (VAT), Subcutaneous Adipose Tissue (SAT) and Trunk Fat Mass by DXA at Week 48 | Baseline, Week 48 | Change from baseline in VAT, SAT and trunk fat mass was assessed by DXA. Least Square mean was determined by MMRM model for post-baseline measures: Variable is modelled by Gender (Male, Female), Country (Australia, New Zealand, United States of America), Visit, Treatment, and Visit-by-Treatment interaction as fixed effects, and Baseline as a covariate. Variance-Covariance structure= Unstructured. Only participants with non-missing baseline value were included in analysis. No imputation was performed for missing values. |
| Change From Baseline in VAT, SAT and Trunk Fat Mass by DXA at Week 72 | Baseline, Week 72 | Change from baseline in VAT, SAT and trunk fat mass was assessed by DXA. Least Square mean was determined by MMRM model for post-baseline measures: Variable is modelled by Gender (Male, Female), Country (Australia, New Zealand, United States of America), Visit, Treatment, and Visit-by-Treatment interaction as fixed effects, and Baseline as a covariate. Variance-Covariance structure= Unstructured. Only participants with non-missing baseline value were included in analysis. No imputation was performed for missing values. |
| Percentage of Participants With Reduction in Waist Circumference Greater Than or Equal to (≥) 5 cm at Week 48 | Week 48 | Waist circumference was measured in a standing position with a non-stretchable measuring tape to the nearest 0.1 cm. Only participants with non-missing baseline value were included in analysis. |
| Percentage of Participants With Reduction in Body Weight ≥ 5%, ≥ 10% and ≥15% at Week 48 | Week 48 | Body weight was measured in kgs to the nearest 0.1 kg. Only participants with non-missing baseline value were included in analysis. |
| Percentage of Participants With Reduction in Fat Mass ≥ 5% ≥ 10% ≥ 15% by DXA at Week 48 | Week 48 | Only participants with non-missing baseline value were included in analysis. |
| Percentage of Participants Achieving Fat Mass ≥ 10% Reduction With <5% Decrease in Lean Mass by DXA at Week 48 | Week 48 | Only participants with non-missing baseline value were included in analysis. |
| Percentage of Participants Achieving >5 kg Weight Loss and Fat Loss Index (FLI) of >70%, >80%, and >90% by DXA at Week 48 | Week 48 | Fat Lost Index = % change in fat mass/% change in lean mass + % change in fat mass. Only participants with non-missing baseline value were included in analysis. |
| Change From Baseline in Body Fat Mass by Bioelectrical Impedance Analysis (BIA) at Week 48 | Baseline, Week 48 | Change from baseline in body fat mass was assessed through BIA. LS mean was determined using MMRM model for post-baseline measures: Variable is modelled by Treatment, Visit, Treatment-by-Visit interaction, Sex, and Country as fixed effects, with Baseline as a covariate. Variance-Covariance structure = Unstructured. Only participants with non-missing baseline value were included in the analysis. |
| Change From Baseline in Body Fat Mass by BIA at Week 72 | Baseline, Week 72 | Change from baseline in body fat mass was assessed through BIA. LS mean was determined using MMRM model for post-baseline measures: Variable is modelled by Treatment, Visit, Treatment-by-Visit interaction, Sex, and Country as fixed effects, with Baseline as a covariate. Variance-Covariance structure = Unstructured. Only participants with non-missing baseline value were included in the analysis. |
| Percent Change From Baseline in Body Fat by BIA at Week 48 | Baseline, Week 48 | Percent change from baseline in Body fat was assessed through BIA. LS mean was determined using MMRM model for post-baseline measures: Variable is modelled by Treatment, Visit, Treatment-by-Visit interaction, Sex, and Country as fixed effects, with Baseline as a covariate. Variance-Covariance structure = Unstructured. Only participants with non-missing baseline value were included in the analysis. |
| Percent Change From Baseline in Body Fat by BIA at Week 72 | Baseline, Week 72 | Percent change from baseline in Body fat was assessed through BIA. LS mean was determined using MMRM model for post-baseline measures: Variable is modelled by Treatment, Visit, Treatment-by-Visit interaction, Sex, and Country as fixed effects, with Baseline as a covariate. Variance-Covariance structure = Unstructured. Only participants with non-missing baseline value were included in the analysis. |
| Change From Baseline in Lean Mass by DXA at Week 48 | Baseline, Week 48 | Change from baseline in lean mass was assessed by DXA. Least Square mean was determined by mixed model repeated measures (MMRM) model for post-baseline measures: Variable is modelled by Gender (Male, Female), Country (Australia, New Zealand, United States of America), Visit, Treatment, and Visit-by-Treatment interaction as fixed effects, and Baseline as a covariate. Variance-Covariance structure= Unstructured. Only participants with non-missing baseline value were included in analysis. No imputation was performed for missing values. |
| Change From Baseline in Lean Mass by DXA at Week 72 | Baseline, Week 72 | Change from baseline in lean mass was assessed by DXA. Least Square mean was determined by mixed model repeated measures (MMRM) model for post-baseline measures: Variable is modelled by Gender (Male, Female), Country (Australia, New Zealand, United States of America), Visit, Treatment, and Visit-by-Treatment interaction as fixed effects, and Baseline as a covariate. Variance-Covariance structure= Unstructured. Only participants with non-missing baseline value were included in analysis. No imputation was performed for missing values. |
| Percent Change From Baseline in Lean Body Mass by DXA at Week 48 | Baseline, Week 48 | Percent change from baseline in lean body mass was assessed by DXA. Least Square mean was determined by mixed model repeated measures (MMRM) model for post-baseline measures: Variable is modelled by Gender (Male, Female), Country (Australia, New Zealand, United States of America), Visit, Treatment, and Visit-by-Treatment interaction as fixed effects, and Baseline as a covariate. Variance-Covariance structure= Unstructured. Only participants with non-missing baseline value were included in analysis. No imputation was performed for missing values. |
| Percent Change From Baseline in Lean Body Mass by DXA at Week 72 | Baseline, Week 72 | Percent change from baseline in lean body mass was assessed by DXA. Least Square mean was determined by mixed model repeated measures (MMRM) model for post-baseline measures: Variable is modelled by Gender (Male, Female), Country (Australia, New Zealand, United States of America), Visit, Treatment, and Visit-by-Treatment interaction as fixed effects, and Baseline as a covariate. Variance-Covariance structure= Unstructured. Only participants with non-missing baseline value were included in analysis. No imputation was performed for missing values. |
| Percent Change From Baseline in Appendicular Lean Mass by DXA at Week 48 | Baseline, Week 48 | Percent change from baseline in appendicular lean mass was assessed by DXA. Least Square mean was determined by mixed model repeated measures (MMRM) model for post-baseline measures: Variable is modelled by Gender (Male, Female), Country (Australia, New Zealand, United States of America), Visit, Treatment, and Visit-by-Treatment interaction as fixed effects, and Baseline as a covariate. Variance-Covariance structure= Unstructured. Only participants with non-missing baseline value were included in analysis. No imputation was performed for missing values. |
| Percent Change From Baseline in Appendicular Lean Mass by DXA at Week 72 | Baseline, Week 72 | Percent change from baseline in appendicular lean mass was assessed by DXA. Least Square mean was determined by mixed model repeated measures (MMRM) model for post-baseline measures: Variable is modelled by Gender (Male, Female), Country (Australia, New Zealand, United States of America), Visit, Treatment, and Visit-by-Treatment interaction as fixed effects, and Baseline as a covariate. Variance-Covariance structure= Unstructured. Only participants with non-missing baseline value were included in analysis. No imputation was performed for missing values. |
| Change From Baseline in Lean Mass (kg) by BIA at Week 48 | Baseline, Week 48 | Change from baseline in lean mass (kg) was assessed through BIA. LS mean was determined using MMRM model for post-baseline measures: Variable is modelled by Treatment, Visit, Treatment-by-Visit interaction, Sex, and Country as fixed effects, with Baseline as a covariate. Variance-Covariance structure = Unstructured. Only participants with non-missing baseline value were included in the analysis. |
| Change From Baseline in Lean Mass (kg) by BIA at Week 72 | Baseline, Week 72 | Change from baseline in lean mass (kg) was assessed through BIA. LS mean was determined using MMRM model for post-baseline measures: Variable is modelled by Treatment, Visit, Treatment-by-Visit interaction, Sex, and Country as fixed effects, with Baseline as a covariate. Variance-Covariance structure = Unstructured. Only participants with non-missing baseline value were included in the analysis. |
| Percent Change From Baseline in Lean Body Mass by BIA at Week 48 | Baseline, Week 48 | Percent change from baseline in lean body mass was assessed through BIA. LS mean was determined using MMRM model for post-baseline measures: Variable is modelled by Treatment, Visit, Treatment-by-Visit interaction, Sex, and Country as fixed effects, with Baseline as a covariate. Variance-Covariance structure = Unstructured. Only participants with non-missing baseline value were included in the analysis. |
| Percent Change From Baseline in Lean Body Mass by BIA at Week 72 | Baseline, Week 72 | Percent change from baseline in lean body mass was assessed through BIA. LS mean was determined using MMRM model for post-baseline measures: Variable is modelled by Treatment, Visit, Treatment-by-Visit interaction, Sex, and Country as fixed effects, with Baseline as a covariate. Variance-Covariance structure = Unstructured. Only participants with non-missing baseline value were included in the analysis. |
| Percentage of Participants With Body Mass Index (BMI) Categories at Baseline and Week 48 | Baseline, Week 48 | BMI categories: i. Healthy weight: 18.5 kilograms (kg)/meter (m)² to 24.9 kg/m² ii. Overweight: 25 kg/m² to 29.9 kg/m² iii. Obesity class 1: 30 kg/m² to 34.9 kg/m² iv. Obesity class II: 35 kg/m² to 39.9 kg/m² v. Obesity class III: ≥ 40 kg/m2 |
| Percentage of Participants With Baseline Waist-to-Height Ratio (WtHR) Category of <0.5 Having Change From Baseline in Waist-to-Height Ratio (WHtR Ratio) Categories at Week 48 | Baseline up to 48 weeks | WHtR ratio categories: \<0.5; 0.5-0.59; ≥0.6 |
| Percentage of Participants With Baseline WtHR Category of 0.5-0.59 Having Change From Baseline in Waist-to-Height Ratio (WHtR Ratio) Categories at Week 48 | Baseline up to 48 weeks | WHtR ratio categories: \<0.5; 0.5-0.59; ≥0.6 |
| Percentage of Participants With Baseline WtHR Category ≥0.6 Having Change From Baseline in Waist-to-Height Ratio (WHtR Ratio) Categories at Week 48 | Baseline up to 48 weeks | WHtR ratio categories: \<0.5; 0.5-0.59; ≥0.6 |
| Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 48 | Baseline, 48 weeks | HbA1c is the glycosylated fraction of hemoglobin A. It is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least Square mean was determined by MMRM model for post-baseline measures: Variable is modelled by Gender (Male, Female), Country (Australia, New Zealand, United States of America), Visit, Treatment, and Visit-by-Treatment interaction as fixed effects, and Baseline as a covariate. Variance-Covariance structure= Unstructured. Only participants with non-missing baseline value were included in analysis. No imputation was performed for missing values. |
| Change From Baseline in Quality of Life Short Form 36 Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score at Week 24 | Baseline, Week 24 | The SF-36v2 acute form assesses health-related quality of life (HRQoL) on 8 domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. The Physical-Functioning domain assesses limitations due to health "now" and consists of 10-items, each rated on a 3-point Likert scale. Scoring of the domain is norm-based and presented in the form of T-scores, with a mean of 50 and standard deviation of 10; higher scores indicate better levels of function. Range cannot be specified in norm-based scores. |
| Change From Baseline in Quality of Life SF-36v2 Acute Form Total Score Week 24 | Baseline, Week 24 | The SF-36 is a participant-reported outcome measure evaluating participant's health status. It comprises 36 items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. The 8 domains are regrouped into (mental component score \[MCS\] and physical component score \[PCS\] to obtain a total score ranging from 0 to 100, with higher scores indicating better levels of function and/or better health. |
| Change From Baseline in Quality of Life SF-36v2 Acute Form Physical Functioning Domain Score Week 48 | Baseline, Week 48 | The SF-36v2 acute form assesses HRQoL on 8 domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. The Physical-Functioning domain assesses limitations due to health "now" and consists of 10 items, each rated on a 3-point Likert scale. Scoring of the domain is norm-based and presented in the form of T-scores, with a mean of 50 and standard deviation of 10; higher scores indicate better levels of function. Range cannot be specified in norm-based scores |
| Change From Baseline in Quality of Life SF-36v2 Acute Form Total Score at Week 48 | Baseline, Week 48 | The SF-36 is a participant-reported outcome measure evaluating participant's health status. It comprises 36 items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. The 8 domains are regrouped into MCS and PCS to obtain a total score ranging from 0 to 100, with higher scores indicating better levels of function and/or better health. |
| Change From Baseline in Quality of Life SF-36v2 Acute Form Physical Functioning Domain Score Week 72 | Baseline, Week 72 | The SF-36v2 acute form assesses HRQoL on 8 domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. The Physical-Functioning domain assesses limitations due to health "now" and consists of 10 items, each rated on a 3-point Likert scale. Scoring of the domain is norm-based and presented in the form of T-scores, with a mean of 50 and standard deviation of 10; higher scores indicate better levels of function. Range cannot be specified in norm-based scores |
| Change From Baseline in Quality of Life SF-36v2 Acute Form Total Score at Week 72 | Baseline, Week 72 | The SF-36 is a participant-reported outcome measure evaluating participant's health status. It comprises 36 items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. The 8 domains are regrouped into MCS and PCS to obtain a total score ranging from 0 to 100, with higher scores indicating better levels of function and/or better health. |
| Change From Baseline in Impact of Weight on Quality of Life-Lite-Clinical Trials Version (IWQOL-Lite-CT) Physical Function Score and Total Score at Week 24 | Baseline, Week 24 | The IWQOL-Lite-CT is a 20-item, obesity-specific PRO instrument developed for use in obesity clinical trials. It assesses 2 primary domains of obesity-related health-related quality of life (HRQoL): physical (7 items) and psychosocial (13 items). Each item is rated on a scale from 0 (worst) to 100 (best), with higher scores indicating better levels of functioning. The IWQOL-Lite-CT provides composite scores for each domain, as well as a total score, all ranging from 0 to 100. Higher scores reflect better levels of functioning and quality of life. This endpoint shows results for 'physical function score' and 'total score.' |
| Change From Baseline in IWQOL-Lite-CT Physical Function Score and Total Score at Week 48 | Baseline, Week 48 | The IWQOL-Lite-CT is a 20-item, obesity-specific PRO instrument developed for use in obesity clinical trials. It assesses 2 primary domains of obesity-related health-related quality of life (HRQoL): physical (7 items) and psychosocial (13 items). Each item is rated on a scale from 0 (worst) to 100 (best), with higher scores indicating better levels of functioning. The IWQOL-Lite-CT provides composite scores for each domain, as well as a total score, all ranging from 0 to 100. Higher scores reflect better levels of functioning and quality of life. This endpoint shows results for 'physical function score' and 'total score.' |
| Change From Baseline in IWQOL-Lite-CT Physical Function Score and Total Score at Week 72 | Baseline, Week 72 | The IWQOL-Lite-CT is a 20-item, obesity-specific PRO instrument developed for use in obesity clinical trials. It assesses 2 primary domains of obesity-related health-related quality of life (HRQoL): physical (7 items) and psychosocial (13 items). Each item is rated on a scale from 0 (worst) to 100 (best), with higher scores indicating better levels of functioning. The IWQOL-Lite-CT provides composite scores for each domain, as well as a total score, all ranging from 0 to 100. Higher scores reflect better levels of functioning and quality of life. This endpoint shows results for 'physical function score' and 'total score.' |
Countries
Australia, New Zealand, United States
Contacts
STUDY_DIRECTORCall 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants received a placebo administered intravenously (IV) at baseline and at weeks 4, 16, 28, and 40 during the core treatment period. | 56 |
| Bimagrumab 10 mg/kg Participants received bimagrumab 10 milligrams/kilogram (mg/kg) administered IV at baseline and at weeks 4, 16, 28, and 40 during the core treatment period. | 56 |
| Bimagrumab 30 mg/kg Participants received bimagrumab 30 mg/kg administered IV at baseline and at weeks 4, 16, 28, and 40. | 57 |
| Placebo + Semaglutide 1.0 mg Participants received a placebo administered IV at baseline and at Weeks 4, 16, 28, and 40, and 1 milligram (mg) of semaglutide administered subcutaneously (SC) weekly for 48 weeks as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg Weeks 5 to 8: 0.5 mg Weeks 9 to 48: 1.0 mg
. | 56 |
| Placebo + Semaglutide 2.4 mg Participants received a placebo administered IV at baseline and at weeks 4, 16, 28, and 40, and 2.4 mg semaglutide administered SC weekly for 48 weeks as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg Weeks 5 to 8: 0.5 mg Weeks 9 to 12: 1.0 mg Weeks 13 to 16: 1.7 mg Weeks 17 to 48: 2.4 mg. | 57 |
| Bimagrumab 10 mg/kg + Semaglutide 1.0 mg Participants received bimagrumab 10 mg/kg administered IV at baseline and at weeks 4, 16, 28, and 40, and 1 mg semaglutide administered SC weekly for 48 weeks as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg Weeks 5 to 8: 0.5 mg Weeks 9 to 48: 1.0 mg. | 56 |
| Bimagrumab 10 mg/kg + Semaglutide 2.4 mg Participants received bimagrumab 10 mg/kg administered IV at baseline and at weeks 4, 16, 28, and 40, and 2.4 mg semaglutide administered SC weekly for 48 weeks as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg Weeks 5 to 8: 0.5 mg Weeks 9 to 12: 1.0 mg Weeks 13 to 16: 1.7 mg Weeks 17 to 48: 2.4 mg. | 56 |
| Bimagrumab 30 mg/kg + Semaglutide 1.0 mg Participants received bimagrumab 30 mg/kg administered IV at baseline and at weeks 4, 16, 28, and 40, and 1 mg semaglutide administered SC weekly for 48 weeks as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg Weeks 5 to 8: 0.5 mg Weeks 9 to 48: 1.0 mg. | 56 |
| Bimagrumab 30 mg/kg + Semaglutide 2.4 mg Participants received bimagrumab 30 mg/kg administered IV at baseline and at weeks 4, 16, 28 and 40, and 2.4 mg semaglutide administered SC weekly for 48 weeks as per the below dose escalation schedule:
Weeks 1 to 4: 0.25 mg Weeks 5 to 8: 0.5 mg Weeks 9 to 12: 1.0 mg Weeks 13 to 16: 1.7 mg Weeks 17 to 48: 2.4 mg. | 57 |
| Total | 507 |
Baseline characteristics
| Characteristic | Placebo | Bimagrumab 10 mg/kg | Bimagrumab 30 mg/kg | Placebo + Semaglutide 1.0 mg | Placebo + Semaglutide 2.4 mg | Bimagrumab 10 mg/kg + Semaglutide 1.0 mg | Bimagrumab 10 mg/kg + Semaglutide 2.4 mg | Bimagrumab 30 mg/kg + Semaglutide 1.0 mg | Bimagrumab 30 mg/kg + Semaglutide 2.4 mg | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 47.8 years STANDARD_DEVIATION 14.6 | 44.4 years STANDARD_DEVIATION 10.9 | 49.2 years STANDARD_DEVIATION 12.2 | 50.3 years STANDARD_DEVIATION 11.2 | 49.6 years STANDARD_DEVIATION 11.8 | 44.8 years STANDARD_DEVIATION 12 | 46.2 years STANDARD_DEVIATION 11.7 | 47.7 years STANDARD_DEVIATION 10.4 | 47.5 years STANDARD_DEVIATION 12.7 | 47.5 years STANDARD_DEVIATION 12.1 |
| Body Weight | 109.55 kilogram (kg) STANDARD_DEVIATION 19.33 | 105.12 kilogram (kg) STANDARD_DEVIATION 19.5 | 109.05 kilogram (kg) STANDARD_DEVIATION 17.56 | 105.81 kilogram (kg) STANDARD_DEVIATION 20.02 | 104.50 kilogram (kg) STANDARD_DEVIATION 14.82 | 108.36 kilogram (kg) STANDARD_DEVIATION 18.92 | 108.78 kilogram (kg) STANDARD_DEVIATION 18.41 | 108.19 kilogram (kg) STANDARD_DEVIATION 14.34 | 108.12 kilogram (kg) STANDARD_DEVIATION 18.48 | 107.50 kilogram (kg) STANDARD_DEVIATION 17.97 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 11 Participants | 3 Participants | 4 Participants | 2 Participants | 5 Participants | 7 Participants | 7 Participants | 8 Participants | 53 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 48 Participants | 44 Participants | 53 Participants | 52 Participants | 54 Participants | 50 Participants | 49 Participants | 47 Participants | 48 Participants | 445 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 2 Participants | 1 Participants | 9 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 3 Participants | 1 Participants | 4 Participants | 1 Participants | 3 Participants | 15 Participants |
| Race/Ethnicity, Customized Black | 6 Participants | 3 Participants | 4 Participants | 7 Participants | 5 Participants | 7 Participants | 5 Participants | 6 Participants | 3 Participants | 46 Participants |
| Race/Ethnicity, Customized Multiple | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 5 Participants | 3 Participants | 2 Participants | 1 Participants | 1 Participants | 2 Participants | 6 Participants | 3 Participants | 1 Participants | 24 Participants |
| Race/Ethnicity, Customized Other | 6 Participants | 4 Participants | 4 Participants | 7 Participants | 2 Participants | 5 Participants | 2 Participants | 3 Participants | 3 Participants | 36 Participants |
| Race/Ethnicity, Customized Unknown | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 38 Participants | 44 Participants | 45 Participants | 40 Participants | 46 Participants | 41 Participants | 39 Participants | 43 Participants | 45 Participants | 381 Participants |
| Region of Enrollment Australia | 12 Participants | 8 Participants | 17 Participants | 9 Participants | 19 Participants | 5 Participants | 7 Participants | 14 Participants | 14 Participants | 105 Participants |
| Region of Enrollment New Zealand | 24 Participants | 24 Participants | 23 Participants | 26 Participants | 23 Participants | 25 Participants | 30 Participants | 24 Participants | 23 Participants | 222 Participants |
| Region of Enrollment United States | 20 Participants | 24 Participants | 17 Participants | 21 Participants | 15 Participants | 26 Participants | 19 Participants | 18 Participants | 20 Participants | 180 Participants |
| Sex: Female, Male Female | 32 Participants | 32 Participants | 33 Participants | 32 Participants | 33 Participants | 32 Participants | 32 Participants | 32 Participants | 33 Participants | 291 Participants |
| Sex: Female, Male Male | 24 Participants | 24 Participants | 24 Participants | 24 Participants | 24 Participants | 24 Participants | 24 Participants | 24 Participants | 24 Participants | 216 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 55 | 0 / 56 | 0 / 57 | 0 / 55 | 0 / 56 | 0 / 56 | 0 / 55 | 0 / 56 | 0 / 55 |
| other Total, other adverse events | 46 / 55 | 54 / 56 | 54 / 57 | 52 / 55 | 52 / 56 | 53 / 56 | 54 / 55 | 54 / 56 | 54 / 55 |
| serious Total, serious adverse events | 5 / 55 | 9 / 56 | 8 / 57 | 4 / 55 | 8 / 56 | 7 / 56 | 8 / 55 | 6 / 56 | 7 / 55 |
Outcome results
Primary
Change From Baseline in Body Weight at Week 48
Least square (LS) Mean was determined by analysis of covariance (ANCOVA) model using Baseline + Gender (Male, Female) + Country (Australia, New Zealand, United States of America) + Treatment (Type III sum of squares) as variables. Only participants with non-missing baseline value were included in analysis. Missing values at Week 48 were imputed 100 times based on observed data in the Placebo arm
Time frame: Baseline, Week 48
Population: All randomized participants who received at least one dose of the study drug, had a baseline and at least one post- baseline value for this outcome.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Body Weight at Week 48 | -3.31 kilogram (kg) | Standard Error 1.39 |
| Bimagrumab 10 mg/kg | Change From Baseline in Body Weight at Week 48 | -5.99 kilogram (kg) | Standard Error 1.42 |
| Bimagrumab 30 mg/kg | Change From Baseline in Body Weight at Week 48 | -9.25 kilogram (kg) | Standard Error 1.33 |
| Placebo + Semaglutide 1.0 mg | Change From Baseline in Body Weight at Week 48 | -9.76 kilogram (kg) | Standard Error 1.25 |
| Placebo + Semaglutide 2.4 mg | Change From Baseline in Body Weight at Week 48 | -14.24 kilogram (kg) | Standard Error 1.17 |
| Bimagrumab 10 mg/kg + Semaglutide 1.0 mg | Change From Baseline in Body Weight at Week 48 | -12.73 kilogram (kg) | Standard Error 1.29 |
| Bimagrumab 10 mg/kg + Semaglutide 2.4 mg | Change From Baseline in Body Weight at Week 48 | -14.31 kilogram (kg) | Standard Error 1.34 |
| Bimagrumab 30 mg/kg + Semaglutide 1.0 mg | Change From Baseline in Body Weight at Week 48 | -13.86 kilogram (kg) | Standard Error 1.29 |
| Bimagrumab 30 mg/kg + Semaglutide 2.4 mg | Change From Baseline in Body Weight at Week 48 | -17.79 kilogram (kg) | Standard Error 1.29 |
Comparison: Bima 30mg/kg + Sema 2.4mg vs Placebop-value: <0.00195% CI: [-18, -11]ANCOVA
Comparison: Bima 30mg/kg + Sema 1.0mg vs Placebop-value: <0.00195% CI: [-14, -7.09]ANCOVA
Comparison: Bima 10mg/kg + Sema 2.4mg vs Placebop-value: <0.00195% CI: [-14.4, -7.55]ANCOVA
Comparison: Bima 10mg/kg + Sema 1.0mg vs Placebop-value: <0.00195% CI: [-12.9, -5.93]ANCOVA
Comparison: Sema 2.4mg vs Placebop-value: <0.00195% CI: [-14.4, -7.46]ANCOVA
Comparison: Sema 1.0mg vs Placebop-value: <0.00195% CI: [-9.96, -2.94]ANCOVA
Comparison: Bima 30mg/kg vs Placebop-value: <0.00195% CI: [-9.47, -2.41]ANCOVA
Comparison: Bima 10mg/kg vs Placebop-value: 0.13395% CI: [-6.18, 0.82]ANCOVA
Secondary
Change From Baseline in Appendicular Lean Mass by DXA at Week 48
DXA was used to assess changes in body composition. LS Mean was determined by ANCOVA model using Baseline + Gender (Male, Female) + Country (Australia, New Zealand, United States of America) + Treatment (Type III sum of squares) as variables. Only participants with non-missing baseline value were included in analysis. Missing values at Week 48 were imputed 100 times based on observed data in the Placebo arm.
Time frame: Baseline, Week 48
Population: All randomized participants who received at least one dose of the study drug, had a baseline and at least one post- baseline value for this outcome.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Appendicular Lean Mass by DXA at Week 48 | -0.3 kg | Standard Error 0.36 |
| Bimagrumab 10 mg/kg | Change From Baseline in Appendicular Lean Mass by DXA at Week 48 | 0.3 kg | Standard Error 0.35 |
| Bimagrumab 30 mg/kg | Change From Baseline in Appendicular Lean Mass by DXA at Week 48 | 0.2 kg | Standard Error 0.34 |
| Placebo + Semaglutide 1.0 mg | Change From Baseline in Appendicular Lean Mass by DXA at Week 48 | -1.2 kg | Standard Error 0.28 |
| Placebo + Semaglutide 2.4 mg | Change From Baseline in Appendicular Lean Mass by DXA at Week 48 | -2.0 kg | Standard Error 0.27 |
| Bimagrumab 10 mg/kg + Semaglutide 1.0 mg | Change From Baseline in Appendicular Lean Mass by DXA at Week 48 | -0.5 kg | Standard Error 0.3 |
| Bimagrumab 10 mg/kg + Semaglutide 2.4 mg | Change From Baseline in Appendicular Lean Mass by DXA at Week 48 | -0.6 kg | Standard Error 0.31 |
| Bimagrumab 30 mg/kg + Semaglutide 1.0 mg | Change From Baseline in Appendicular Lean Mass by DXA at Week 48 | -0.4 kg | Standard Error 0.3 |
| Bimagrumab 30 mg/kg + Semaglutide 2.4 mg | Change From Baseline in Appendicular Lean Mass by DXA at Week 48 | -0.5 kg | Standard Error 0.28 |
Secondary
Change From Baseline in Appendicular Lean Mass by DXA at Week 72
DXA was used to assess changes in body composition.
Time frame: Baseline, Week 72
Secondary
Change From Baseline in Body Fat Mass by BIA at Week 72
Body fat mass was assessed through BIA.
Time frame: Baseline, Week 72
Secondary
Change From Baseline in Body Fat Mass by Bioelectrical Impedance Analysis (BIA) at Week 48
Body fat was assessed through BIA. LS Mean was determined by ANCOVA model using Baseline + Gender (Male, Female) + Country (Australia, New Zealand, United States of America) + Treatment (Type III sum of squares) as variables. Only participants with non-missing baseline value were included in analysis. Missing values at Week 48 were imputed 100 times based on observed data in the Placebo arm.
Time frame: Baseline, Week 48
Population: All randomized participants who received at least one dose of the study drug, had a baseline and at least one post- baseline value for this outcome.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Body Fat Mass by Bioelectrical Impedance Analysis (BIA) at Week 48 | -2.78 kg | Standard Error 1.12 |
| Bimagrumab 10 mg/kg | Change From Baseline in Body Fat Mass by Bioelectrical Impedance Analysis (BIA) at Week 48 | -5.64 kg | Standard Error 1.16 |
| Bimagrumab 30 mg/kg | Change From Baseline in Body Fat Mass by Bioelectrical Impedance Analysis (BIA) at Week 48 | -7.59 kg | Standard Error 1.01 |
| Placebo + Semaglutide 1.0 mg | Change From Baseline in Body Fat Mass by Bioelectrical Impedance Analysis (BIA) at Week 48 | -6.95 kg | Standard Error 0.99 |
| Placebo + Semaglutide 2.4 mg | Change From Baseline in Body Fat Mass by Bioelectrical Impedance Analysis (BIA) at Week 48 | -10.08 kg | Standard Error 0.92 |
| Bimagrumab 10 mg/kg + Semaglutide 1.0 mg | Change From Baseline in Body Fat Mass by Bioelectrical Impedance Analysis (BIA) at Week 48 | -10.26 kg | Standard Error 1.03 |
| Bimagrumab 10 mg/kg + Semaglutide 2.4 mg | Change From Baseline in Body Fat Mass by Bioelectrical Impedance Analysis (BIA) at Week 48 | -11.72 kg | Standard Error 1.06 |
| Bimagrumab 30 mg/kg + Semaglutide 1.0 mg | Change From Baseline in Body Fat Mass by Bioelectrical Impedance Analysis (BIA) at Week 48 | -11.71 kg | Standard Error 0.99 |
| Bimagrumab 30 mg/kg + Semaglutide 2.4 mg | Change From Baseline in Body Fat Mass by Bioelectrical Impedance Analysis (BIA) at Week 48 | -13.74 kg | Standard Error 1 |
Secondary
Change From Baseline in Body Fat Percentage at Week 48
Body fat percentage was obtained by DXA was used to assess changes in body composition. LS Mean was determined by ANCOVA model using Baseline + Gender (Male, Female) + Country (Australia, New Zealand, United States of America) + Treatment (Type III sum of squares) as variables. Only participants with non-missing baseline value were included in analysis. Missing values at Week 48 were imputed 100 times based on observed data in the Placebo arm.
Time frame: Baseline, Week 48
Population: All randomized participants who received at least one dose of the study drug, had a baseline and at least one post- baseline value for this outcome.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Body Fat Percentage at Week 48 | -1.02 percentage of body fat | Standard Error 0.74 |
| Bimagrumab 10 mg/kg | Change From Baseline in Body Fat Percentage at Week 48 | -3.42 percentage of body fat | Standard Error 0.76 |
| Bimagrumab 30 mg/kg | Change From Baseline in Body Fat Percentage at Week 48 | -5.23 percentage of body fat | Standard Error 0.7 |
| Placebo + Semaglutide 1.0 mg | Change From Baseline in Body Fat Percentage at Week 48 | -3.27 percentage of body fat | Standard Error 0.68 |
| Placebo + Semaglutide 2.4 mg | Change From Baseline in Body Fat Percentage at Week 48 | -4.18 percentage of body fat | Standard Error 0.66 |
| Bimagrumab 10 mg/kg + Semaglutide 1.0 mg | Change From Baseline in Body Fat Percentage at Week 48 | -6.25 percentage of body fat | Standard Error 0.69 |
| Bimagrumab 10 mg/kg + Semaglutide 2.4 mg | Change From Baseline in Body Fat Percentage at Week 48 | -7.13 percentage of body fat | Standard Error 0.7 |
| Bimagrumab 30 mg/kg + Semaglutide 1.0 mg | Change From Baseline in Body Fat Percentage at Week 48 | -7.46 percentage of body fat | Standard Error 0.68 |
| Bimagrumab 30 mg/kg + Semaglutide 2.4 mg | Change From Baseline in Body Fat Percentage at Week 48 | -9.30 percentage of body fat | Standard Error 0.67 |
Secondary
Change From Baseline in Body Fat Percentage at Week 72
Percent body fat obtained by DXA was used to assess changes in body composition.
Time frame: Baseline, Week 72
Secondary
Change From Baseline in Body Fat Percentage by BIA at Week 48
Body fat percentage was assessed through BIA. LS Mean was determined by ANCOVA model using Baseline + Gender (Male, Female) + Country (Australia, New Zealand, United States of America) + Treatment (Type III sum of squares) as variables. Only participants with non-missing baseline value were included in analysis. Missing values at Week 48 were imputed 100 times based on observed data in the Placebo arm.
Time frame: Baseline, Week 48
Population: All randomized participants who received at least one dose of the study drug, had a baseline and at least one post- baseline value for this outcome.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Body Fat Percentage by BIA at Week 48 | -1.69 percentage of body fat | Standard Error 0.65 |
| Bimagrumab 10 mg/kg | Change From Baseline in Body Fat Percentage by BIA at Week 48 | -3.04 percentage of body fat | Standard Error 0.67 |
| Bimagrumab 30 mg/kg | Change From Baseline in Body Fat Percentage by BIA at Week 48 | -4.21 percentage of body fat | Standard Error 0.61 |
| Placebo + Semaglutide 1.0 mg | Change From Baseline in Body Fat Percentage by BIA at Week 48 | -3.42 percentage of body fat | Standard Error 0.6 |
| Placebo + Semaglutide 2.4 mg | Change From Baseline in Body Fat Percentage by BIA at Week 48 | -4.71 percentage of body fat | Standard Error 0.56 |
| Bimagrumab 10 mg/kg + Semaglutide 1.0 mg | Change From Baseline in Body Fat Percentage by BIA at Week 48 | -5.54 percentage of body fat | Standard Error 0.62 |
| Bimagrumab 10 mg/kg + Semaglutide 2.4 mg | Change From Baseline in Body Fat Percentage by BIA at Week 48 | -6.77 percentage of body fat | Standard Error 0.62 |
| Bimagrumab 30 mg/kg + Semaglutide 1.0 mg | Change From Baseline in Body Fat Percentage by BIA at Week 48 | -6.81 percentage of body fat | Standard Error 0.6 |
| Bimagrumab 30 mg/kg + Semaglutide 2.4 mg | Change From Baseline in Body Fat Percentage by BIA at Week 48 | -7.40 percentage of body fat | Standard Error 0.59 |
Secondary
Change From Baseline in Body Fat Percentage by BIA at Week 72
Body fat percentage was assessed through BIA.
Time frame: Baseline, Week 72
Secondary
Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 48
HbA1c is the glycosylated fraction of hemoglobin A. It is measured primarily to identify the average plasma glucose concentration over prolonged periods of time.
Time frame: Baseline, 48 weeks
Population: All randomized participants who received at least one dose of the study drug, had a baseline and at least one post- baseline value for this outcome.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 48 | -0.0 percentage of HbA1c | Standard Error 0.05 |
| Bimagrumab 10 mg/kg | Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 48 | -0.2 percentage of HbA1c | Standard Error 0.06 |
| Bimagrumab 30 mg/kg | Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 48 | -0.2 percentage of HbA1c | Standard Error 0.05 |
| Placebo + Semaglutide 1.0 mg | Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 48 | -0.3 percentage of HbA1c | Standard Error 0.05 |
| Placebo + Semaglutide 2.4 mg | Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 48 | -0.4 percentage of HbA1c | Standard Error 0.04 |
| Bimagrumab 10 mg/kg + Semaglutide 1.0 mg | Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 48 | -0.3 percentage of HbA1c | Standard Error 0.05 |
| Bimagrumab 10 mg/kg + Semaglutide 2.4 mg | Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 48 | -0.5 percentage of HbA1c | Standard Error 0.05 |
| Bimagrumab 30 mg/kg + Semaglutide 1.0 mg | Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 48 | -0.4 percentage of HbA1c | Standard Error 0.05 |
| Bimagrumab 30 mg/kg + Semaglutide 2.4 mg | Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 48 | -0.4 percentage of HbA1c | Standard Error 0.05 |
Secondary
Change From Baseline in Impact of Weight on Quality of Life-Lite-Clinical Trials Version (IWQOL-Lite-CT) Physical Function Score and Total Score at Week 24
The IWQOL-Lite-CT is a 20-item, obesity-specific PRO instrument developed for use in obesity clinical trials. It assesses 2 primary domains of obesity-related health-related quality of life (HRQoL): physical (7 items) and psychosocial (13 items). Each item is rated on a scale from 0 (worst) to 100 (best), with higher scores indicating better levels of functioning. The IWQOL-Lite-CT provides composite scores for each domain, as well as a total score, all ranging from 0 to 100. Higher scores reflect better levels of functioning and quality of life. This endpoint shows results for 'physical function score' and 'total score.'
Time frame: Baseline, Week 24
Population: All randomized participants who received at least one dose of the study drug, had a baseline and at least one post- baseline value for this outcome.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Impact of Weight on Quality of Life-Lite-Clinical Trials Version (IWQOL-Lite-CT) Physical Function Score and Total Score at Week 24 | Physical Function Score | 7.973 score on a scale | Standard Deviation 15.919 |
| Placebo | Change From Baseline in Impact of Weight on Quality of Life-Lite-Clinical Trials Version (IWQOL-Lite-CT) Physical Function Score and Total Score at Week 24 | Total score | 8.142 score on a scale | Standard Deviation 11.538 |
| Bimagrumab 10 mg/kg | Change From Baseline in Impact of Weight on Quality of Life-Lite-Clinical Trials Version (IWQOL-Lite-CT) Physical Function Score and Total Score at Week 24 | Physical Function Score | 13.289 score on a scale | Standard Deviation 13.115 |
| Bimagrumab 10 mg/kg | Change From Baseline in Impact of Weight on Quality of Life-Lite-Clinical Trials Version (IWQOL-Lite-CT) Physical Function Score and Total Score at Week 24 | Total score | 10.789 score on a scale | Standard Deviation 10.363 |
| Bimagrumab 30 mg/kg | Change From Baseline in Impact of Weight on Quality of Life-Lite-Clinical Trials Version (IWQOL-Lite-CT) Physical Function Score and Total Score at Week 24 | Physical Function Score | 13.974 score on a scale | Standard Deviation 13.726 |
| Bimagrumab 30 mg/kg | Change From Baseline in Impact of Weight on Quality of Life-Lite-Clinical Trials Version (IWQOL-Lite-CT) Physical Function Score and Total Score at Week 24 | Total score | 15.513 score on a scale | Standard Deviation 11.868 |
| Placebo + Semaglutide 1.0 mg | Change From Baseline in Impact of Weight on Quality of Life-Lite-Clinical Trials Version (IWQOL-Lite-CT) Physical Function Score and Total Score at Week 24 | Physical Function Score | 16.667 score on a scale | Standard Deviation 14.616 |
| Placebo + Semaglutide 1.0 mg | Change From Baseline in Impact of Weight on Quality of Life-Lite-Clinical Trials Version (IWQOL-Lite-CT) Physical Function Score and Total Score at Week 24 | Total score | 17.639 score on a scale | Standard Deviation 11.285 |
| Placebo + Semaglutide 2.4 mg | Change From Baseline in Impact of Weight on Quality of Life-Lite-Clinical Trials Version (IWQOL-Lite-CT) Physical Function Score and Total Score at Week 24 | Physical Function Score | 17.447 score on a scale | Standard Deviation 16.677 |
| Placebo + Semaglutide 2.4 mg | Change From Baseline in Impact of Weight on Quality of Life-Lite-Clinical Trials Version (IWQOL-Lite-CT) Physical Function Score and Total Score at Week 24 | Total score | 19.468 score on a scale | Standard Deviation 13.055 |
| Bimagrumab 10 mg/kg + Semaglutide 1.0 mg | Change From Baseline in Impact of Weight on Quality of Life-Lite-Clinical Trials Version (IWQOL-Lite-CT) Physical Function Score and Total Score at Week 24 | Total score | 19.468 score on a scale | Standard Deviation 13.055 |
| Bimagrumab 10 mg/kg + Semaglutide 1.0 mg | Change From Baseline in Impact of Weight on Quality of Life-Lite-Clinical Trials Version (IWQOL-Lite-CT) Physical Function Score and Total Score at Week 24 | Physical Function Score | 14.659 score on a scale | Standard Deviation 16.474 |
| Bimagrumab 10 mg/kg + Semaglutide 2.4 mg | Change From Baseline in Impact of Weight on Quality of Life-Lite-Clinical Trials Version (IWQOL-Lite-CT) Physical Function Score and Total Score at Week 24 | Total score | 14.671 score on a scale | Standard Deviation 16.434 |
| Bimagrumab 10 mg/kg + Semaglutide 2.4 mg | Change From Baseline in Impact of Weight on Quality of Life-Lite-Clinical Trials Version (IWQOL-Lite-CT) Physical Function Score and Total Score at Week 24 | Physical Function Score | 12.105 score on a scale | Standard Deviation 22.68 |
| Bimagrumab 30 mg/kg + Semaglutide 1.0 mg | Change From Baseline in Impact of Weight on Quality of Life-Lite-Clinical Trials Version (IWQOL-Lite-CT) Physical Function Score and Total Score at Week 24 | Physical Function Score | 18.690 score on a scale | Standard Deviation 19.818 |
| Bimagrumab 30 mg/kg + Semaglutide 1.0 mg | Change From Baseline in Impact of Weight on Quality of Life-Lite-Clinical Trials Version (IWQOL-Lite-CT) Physical Function Score and Total Score at Week 24 | Total score | 17.113 score on a scale | Standard Deviation 14.463 |
| Bimagrumab 30 mg/kg + Semaglutide 2.4 mg | Change From Baseline in Impact of Weight on Quality of Life-Lite-Clinical Trials Version (IWQOL-Lite-CT) Physical Function Score and Total Score at Week 24 | Physical Function Score | 21.667 score on a scale | Standard Deviation 17.113 |
| Bimagrumab 30 mg/kg + Semaglutide 2.4 mg | Change From Baseline in Impact of Weight on Quality of Life-Lite-Clinical Trials Version (IWQOL-Lite-CT) Physical Function Score and Total Score at Week 24 | Total score | 22.917 score on a scale | Standard Deviation 14.826 |
Secondary
Change From Baseline in IWQOL-Lite-CT Physical Function Score and Total Score at Week 48
The IWQOL-Lite-CT is a 20-item, obesity-specific PRO instrument developed for use in obesity clinical trials. It assesses 2 primary domains of obesity-related health-related quality of life (HRQoL): physical (7 items) and psychosocial (13 items). Each item is rated on a scale from 0 (worst) to 100 (best), with higher scores indicating better levels of functioning. The IWQOL-Lite-CT provides composite scores for each domain, as well as a total score, all ranging from 0 to 100. Higher scores reflect better levels of functioning and quality of life. This endpoint shows results for 'physical function score' and 'total score.'
Time frame: Baseline, Week 48
Population: All randomized participants who received at least one dose of the study drug, had a baseline and at least one post- baseline value for this outcome. LS Mean was determined by ANCOVA model using Baseline + Gender(Male, Female) + Country(Australia,New Zealand,United States of America) + Treatment (Type III sum of squares) as variables. Only participants with non-missing baseline value were included in analysis. Missing values at Week 48 imputed 100 times based on observed data in the Placebo arm.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in IWQOL-Lite-CT Physical Function Score and Total Score at Week 48 | Physical Function Score | 13.3 score on a scale | Standard Error 2.65 |
| Placebo | Change From Baseline in IWQOL-Lite-CT Physical Function Score and Total Score at Week 48 | Total Score | 14.1 score on a scale | Standard Error 2.42 |
| Bimagrumab 10 mg/kg | Change From Baseline in IWQOL-Lite-CT Physical Function Score and Total Score at Week 48 | Physical Function Score | 15.6 score on a scale | Standard Error 2.71 |
| Bimagrumab 10 mg/kg | Change From Baseline in IWQOL-Lite-CT Physical Function Score and Total Score at Week 48 | Total Score | 14.7 score on a scale | Standard Error 2.36 |
| Bimagrumab 30 mg/kg | Change From Baseline in IWQOL-Lite-CT Physical Function Score and Total Score at Week 48 | Physical Function Score | 16.1 score on a scale | Standard Error 2.62 |
| Bimagrumab 30 mg/kg | Change From Baseline in IWQOL-Lite-CT Physical Function Score and Total Score at Week 48 | Total Score | 16.6 score on a scale | Standard Error 2.4 |
| Placebo + Semaglutide 1.0 mg | Change From Baseline in IWQOL-Lite-CT Physical Function Score and Total Score at Week 48 | Physical Function Score | 15.3 score on a scale | Standard Error 2.41 |
| Placebo + Semaglutide 1.0 mg | Change From Baseline in IWQOL-Lite-CT Physical Function Score and Total Score at Week 48 | Total Score | 17.5 score on a scale | Standard Error 2.19 |
| Placebo + Semaglutide 2.4 mg | Change From Baseline in IWQOL-Lite-CT Physical Function Score and Total Score at Week 48 | Physical Function Score | 19.5 score on a scale | Standard Error 2.33 |
| Placebo + Semaglutide 2.4 mg | Change From Baseline in IWQOL-Lite-CT Physical Function Score and Total Score at Week 48 | Total Score | 21.6 score on a scale | Standard Error 2.17 |
| Bimagrumab 10 mg/kg + Semaglutide 1.0 mg | Change From Baseline in IWQOL-Lite-CT Physical Function Score and Total Score at Week 48 | Total Score | 22.4 score on a scale | Standard Error 2.26 |
| Bimagrumab 10 mg/kg + Semaglutide 1.0 mg | Change From Baseline in IWQOL-Lite-CT Physical Function Score and Total Score at Week 48 | Physical Function Score | 18.7 score on a scale | Standard Error 2.57 |
| Bimagrumab 10 mg/kg + Semaglutide 2.4 mg | Change From Baseline in IWQOL-Lite-CT Physical Function Score and Total Score at Week 48 | Total Score | 19.2 score on a scale | Standard Error 2.33 |
| Bimagrumab 10 mg/kg + Semaglutide 2.4 mg | Change From Baseline in IWQOL-Lite-CT Physical Function Score and Total Score at Week 48 | Physical Function Score | 19.3 score on a scale | Standard Error 2.53 |
| Bimagrumab 30 mg/kg + Semaglutide 1.0 mg | Change From Baseline in IWQOL-Lite-CT Physical Function Score and Total Score at Week 48 | Physical Function Score | 21.6 score on a scale | Standard Error 2.58 |
| Bimagrumab 30 mg/kg + Semaglutide 1.0 mg | Change From Baseline in IWQOL-Lite-CT Physical Function Score and Total Score at Week 48 | Total Score | 21.2 score on a scale | Standard Error 2.38 |
| Bimagrumab 30 mg/kg + Semaglutide 2.4 mg | Change From Baseline in IWQOL-Lite-CT Physical Function Score and Total Score at Week 48 | Physical Function Score | 20.2 score on a scale | Standard Error 2.39 |
| Bimagrumab 30 mg/kg + Semaglutide 2.4 mg | Change From Baseline in IWQOL-Lite-CT Physical Function Score and Total Score at Week 48 | Total Score | 23.8 score on a scale | Standard Error 2.22 |
Secondary
Change From Baseline in IWQOL-Lite-CT Physical Function Score and Total Score at Week 72
The IWQOL-Lite-CT is a 20-item, obesity-specific PRO instrument developed for use in obesity clinical trials. It assesses 2 primary domains of obesity-related health-related quality of life (HRQoL): physical (7 items) and psychosocial (13 items). Each item is rated on a scale from 0 (worst) to 100 (best), with higher scores indicating better levels of functioning. The IWQOL-Lite-CT provides composite scores for each domain, as well as a total score, all ranging from 0 to 100. Higher scores reflect better levels of functioning and quality of life. This endpoint shows results for 'physical function score' and 'total score.'
Time frame: Baseline, Week 72
Secondary
Change From Baseline in Lean Body Mass Percentage by DXA at Week 48
Lean body mass percentage was assessed through DXA. LS Mean was determined by ANCOVA model using Baseline + Gender (Male, Female) + Country (Australia, New Zealand, United States of America) + Treatment (Type III sum of squares) as variables. Only participants with non-missing baseline value were included in analysis. Missing values at Week 48 were imputed 100 times based on observed data in the Placebo arm
Time frame: Baseline, Week 48
Population: All randomized participants who received at least one dose of the study drug, had a baseline and at least one post- baseline value for this outcome.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Lean Body Mass Percentage by DXA at Week 48 | 0.94 percentage of body mass | Standard Error 0.69 |
| Bimagrumab 10 mg/kg | Change From Baseline in Lean Body Mass Percentage by DXA at Week 48 | 3.38 percentage of body mass | Standard Error 0.72 |
| Bimagrumab 30 mg/kg | Change From Baseline in Lean Body Mass Percentage by DXA at Week 48 | 5.05 percentage of body mass | Standard Error 0.67 |
| Placebo + Semaglutide 1.0 mg | Change From Baseline in Lean Body Mass Percentage by DXA at Week 48 | 3.03 percentage of body mass | Standard Error 0.65 |
| Placebo + Semaglutide 2.4 mg | Change From Baseline in Lean Body Mass Percentage by DXA at Week 48 | 3.81 percentage of body mass | Standard Error 0.62 |
| Bimagrumab 10 mg/kg + Semaglutide 1.0 mg | Change From Baseline in Lean Body Mass Percentage by DXA at Week 48 | 5.94 percentage of body mass | Standard Error 0.66 |
| Bimagrumab 10 mg/kg + Semaglutide 2.4 mg | Change From Baseline in Lean Body Mass Percentage by DXA at Week 48 | 6.78 percentage of body mass | Standard Error 0.67 |
| Bimagrumab 30 mg/kg + Semaglutide 1.0 mg | Change From Baseline in Lean Body Mass Percentage by DXA at Week 48 | 7.13 percentage of body mass | Standard Error 0.65 |
| Bimagrumab 30 mg/kg + Semaglutide 2.4 mg | Change From Baseline in Lean Body Mass Percentage by DXA at Week 48 | 8.84 percentage of body mass | Standard Error 0.65 |
Secondary
Change From Baseline in Lean Body Mass Percentage by DXA at Week 72
DXA was used to assess changes in body composition.
Time frame: Baseline, Week 72
Secondary
Change From Baseline in Lean Mass by DXA at Week 48
Lean mass was assessed through DXA. LS Mean was determined by ANCOVA model using Baseline + Gender (Male, Female) + Country (Australia, New Zealand, United States of America) + Treatment (Type III sum of squares) as variables. Only participants with non-missing baseline value were included in analysis. Missing values at Week 48 were imputed 100 times based on observed data in the Placebo arm
Time frame: Baseline, Week 48
Population: All randomized participants who received at least one dose of the study drug, had a baseline and at least one post- baseline value for this outcome.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Lean Mass by DXA at Week 48 | -0.5 kg | Standard Error 0.68 |
| Bimagrumab 10 mg/kg | Change From Baseline in Lean Mass by DXA at Week 48 | 0.5 kg | Standard Error 0.7 |
| Bimagrumab 30 mg/kg | Change From Baseline in Lean Mass by DXA at Week 48 | 0.4 kg | Standard Error 0.65 |
| Placebo + Semaglutide 1.0 mg | Change From Baseline in Lean Mass by DXA at Week 48 | -2.6 kg | Standard Error 0.57 |
| Placebo + Semaglutide 2.4 mg | Change From Baseline in Lean Mass by DXA at Week 48 | -3.9 kg | Standard Error 0.56 |
| Bimagrumab 10 mg/kg + Semaglutide 1.0 mg | Change From Baseline in Lean Mass by DXA at Week 48 | -1.1 kg | Standard Error 0.63 |
| Bimagrumab 10 mg/kg + Semaglutide 2.4 mg | Change From Baseline in Lean Mass by DXA at Week 48 | -1.2 kg | Standard Error 0.61 |
| Bimagrumab 30 mg/kg + Semaglutide 1.0 mg | Change From Baseline in Lean Mass by DXA at Week 48 | -0.5 kg | Standard Error 0.61 |
| Bimagrumab 30 mg/kg + Semaglutide 2.4 mg | Change From Baseline in Lean Mass by DXA at Week 48 | -1.3 kg | Standard Error 0.58 |
Secondary
Change From Baseline in Lean Mass by DXA at Week 72
Lean mass was assessed through DXA.
Time frame: Baseline, Week 72
Secondary
Change From Baseline in Lean Mass (kg) by BIA at Week 48
BIA is a widely used method for estimating body composition. LS Mean was determined by ANCOVA model using Baseline + Gender (Male, Female) + Country (Australia, New Zealand, United States of America) + Treatment (Type III sum of squares) as variables. Only participants with non-missing baseline value were included in analysis. Missing values at Week 48 were imputed 100 times based on observed data in the Placebo arm.
Time frame: Baseline, Week 48
Population: All randomized participants who received at least one dose of the study drug, had a baseline and at least one post- baseline value for this outcome.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Lean Mass (kg) by BIA at Week 48 | -0.71 kg | Standard Error 0.51 |
| Bimagrumab 10 mg/kg | Change From Baseline in Lean Mass (kg) by BIA at Week 48 | -0.62 kg | Standard Error 0.53 |
| Bimagrumab 30 mg/kg | Change From Baseline in Lean Mass (kg) by BIA at Week 48 | -1.50 kg | Standard Error 0.51 |
| Placebo + Semaglutide 1.0 mg | Change From Baseline in Lean Mass (kg) by BIA at Week 48 | -2.97 kg | Standard Error 0.49 |
| Placebo + Semaglutide 2.4 mg | Change From Baseline in Lean Mass (kg) by BIA at Week 48 | -3.99 kg | Standard Error 0.47 |
| Bimagrumab 10 mg/kg + Semaglutide 1.0 mg | Change From Baseline in Lean Mass (kg) by BIA at Week 48 | -2.30 kg | Standard Error 0.5 |
| Bimagrumab 10 mg/kg + Semaglutide 2.4 mg | Change From Baseline in Lean Mass (kg) by BIA at Week 48 | -2.50 kg | Standard Error 0.5 |
| Bimagrumab 30 mg/kg + Semaglutide 1.0 mg | Change From Baseline in Lean Mass (kg) by BIA at Week 48 | -2.39 kg | Standard Error 0.48 |
| Bimagrumab 30 mg/kg + Semaglutide 2.4 mg | Change From Baseline in Lean Mass (kg) by BIA at Week 48 | -3.79 kg | Standard Error 0.5 |
Secondary
Change From Baseline in Lean Mass (kg) by BIA at Week 72
BIA is a widely used method for estimating body composition.
Time frame: Baseline, Week 72
Secondary
Change From Baseline in Percentage Lean Body Mass by BIA at Week 48
BIA is a widely used method for estimating body composition. LS Mean was determined by ANCOVA model using Baseline + Gender (Male, Female) + Country (Australia, New Zealand, United States of America) + Treatment (Type III sum of squares) as variables. Only participants with non-missing baseline value were included in analysis. Missing values at Week 48 were imputed 100 times based on observed data in the Placebo arm.
Time frame: Baseline, Week 48
Population: All randomized participants who received at least one dose of the study drug, had a baseline and at least one post- baseline value for this outcome.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Percentage Lean Body Mass by BIA at Week 48 | 2.16 percentage of body mass | Standard Error 0.73 |
| Bimagrumab 10 mg/kg | Change From Baseline in Percentage Lean Body Mass by BIA at Week 48 | 2.80 percentage of body mass | Standard Error 0.8 |
| Bimagrumab 30 mg/kg | Change From Baseline in Percentage Lean Body Mass by BIA at Week 48 | 4.17 percentage of body mass | Standard Error 0.69 |
| Placebo + Semaglutide 1.0 mg | Change From Baseline in Percentage Lean Body Mass by BIA at Week 48 | 3.75 percentage of body mass | Standard Error 0.68 |
| Placebo + Semaglutide 2.4 mg | Change From Baseline in Percentage Lean Body Mass by BIA at Week 48 | 4.79 percentage of body mass | Standard Error 0.64 |
| Bimagrumab 10 mg/kg + Semaglutide 1.0 mg | Change From Baseline in Percentage Lean Body Mass by BIA at Week 48 | 5.42 percentage of body mass | Standard Error 0.71 |
| Bimagrumab 10 mg/kg + Semaglutide 2.4 mg | Change From Baseline in Percentage Lean Body Mass by BIA at Week 48 | 6.62 percentage of body mass | Standard Error 0.7 |
| Bimagrumab 30 mg/kg + Semaglutide 1.0 mg | Change From Baseline in Percentage Lean Body Mass by BIA at Week 48 | 6.08 percentage of body mass | Standard Error 0.67 |
| Bimagrumab 30 mg/kg + Semaglutide 2.4 mg | Change From Baseline in Percentage Lean Body Mass by BIA at Week 48 | 6.95 percentage of body mass | Standard Error 0.67 |
Secondary
Change From Baseline in Percentage Lean Body Mass by BIA at Week 72
BIA is a widely used method for estimating body composition.
Time frame: Baseline, Week 72
Secondary
Change From Baseline in Quality of Life SF-36v2 Acute Form Physical Functioning Domain Score and Total Score at Week 72
The SF-36v2 acute, 1-week recall version is a 36-item, generic, patient-administered measure designed to assess the following 8 domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. The Physical-Functioning domain assesses limitations due to health now while the remaining domains assess functioning in the past week. Each domain is scored individually and information from these 8 domains are further aggregated into 2 health-component summary scores: Physical-Component Summary and Mental-Component Summary. Items are answered on Likert scales of varying lengths (3-, 5-, or 6- point scales).The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health.
Time frame: Baseline, Week 72
Secondary
Change From Baseline in Quality of Life SF-36v2 Acute Form Physical Functioning Domain Score Week 48
The SF-36v2 acute form assesses HRQoL on 8 domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. The Physical-Functioning domain assesses limitations due to health now and consists of 10 items, each rated on a 3-point Likert scale. Scoring of the domain is norm-based and presented in the form of T-scores, with a mean of 50 and standard deviation of 10; higher scores indicate better levels of function. Range cannot be specified in norm-based scores
Time frame: Baseline, Week 48
Population: All randomized participants who received at least one dose of the study drug, had a baseline and at least one post- baseline value for this outcome. LS Mean was determined by ANCOVA model using Baseline + Gender(Male, Female) + Country(Australia,New Zealand,United States of America) + Treatment (Type III sum of squares) as variables. Only participants with non-missing baseline value were included in analysis. Missing values at Week 48 imputed 100 times based on observed data in the Placebo arm.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Quality of Life SF-36v2 Acute Form Physical Functioning Domain Score Week 48 | 11.5 t-score | Standard Error 2.14 |
| Bimagrumab 10 mg/kg | Change From Baseline in Quality of Life SF-36v2 Acute Form Physical Functioning Domain Score Week 48 | 10.8 t-score | Standard Error 2.21 |
| Bimagrumab 30 mg/kg | Change From Baseline in Quality of Life SF-36v2 Acute Form Physical Functioning Domain Score Week 48 | 12.1 t-score | Standard Error 2.07 |
| Placebo + Semaglutide 1.0 mg | Change From Baseline in Quality of Life SF-36v2 Acute Form Physical Functioning Domain Score Week 48 | 10.0 t-score | Standard Error 1.91 |
| Placebo + Semaglutide 2.4 mg | Change From Baseline in Quality of Life SF-36v2 Acute Form Physical Functioning Domain Score Week 48 | 11.6 t-score | Standard Error 1.91 |
| Bimagrumab 10 mg/kg + Semaglutide 1.0 mg | Change From Baseline in Quality of Life SF-36v2 Acute Form Physical Functioning Domain Score Week 48 | 14.6 t-score | Standard Error 2.04 |
| Bimagrumab 10 mg/kg + Semaglutide 2.4 mg | Change From Baseline in Quality of Life SF-36v2 Acute Form Physical Functioning Domain Score Week 48 | 13.0 t-score | Standard Error 2.06 |
| Bimagrumab 30 mg/kg + Semaglutide 1.0 mg | Change From Baseline in Quality of Life SF-36v2 Acute Form Physical Functioning Domain Score Week 48 | 13.0 t-score | Standard Error 2.19 |
| Bimagrumab 30 mg/kg + Semaglutide 2.4 mg | Change From Baseline in Quality of Life SF-36v2 Acute Form Physical Functioning Domain Score Week 48 | 16.1 t-score | Standard Error 1.97 |
Secondary
Change From Baseline in Quality of Life SF-36v2 Acute Form Total Score at Week 48
The SF-36 is a participant-reported outcome measure evaluating participant's health status. It comprises 36 items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. The 8 domains are regrouped into MCS and PCS to obtain a total score ranging from 0 to 100, with higher scores indicating better levels of function and/or better health.
Time frame: Baseline, Week 48
Population: All randomized participants who received at least one dose of the study drug, had a baseline and at least one post- baseline value for this outcome. LS Mean was determined by ANCOVA model using Baseline + Gender(Male, Female) + Country(Australia,New Zealand,United States of America) + Treatment (Type III sum of squares) as variables. Only participants with non-missing baseline value were included in analysis. Missing values at Week 48 imputed 100 times based on observed data in the Placebo arm.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Quality of Life SF-36v2 Acute Form Total Score at Week 48 | 10.9 score on a scale | Standard Error 2.26 |
| Bimagrumab 10 mg/kg | Change From Baseline in Quality of Life SF-36v2 Acute Form Total Score at Week 48 | 8.5 score on a scale | Standard Error 2.43 |
| Bimagrumab 30 mg/kg | Change From Baseline in Quality of Life SF-36v2 Acute Form Total Score at Week 48 | 11.6 score on a scale | Standard Error 2.27 |
| Placebo + Semaglutide 1.0 mg | Change From Baseline in Quality of Life SF-36v2 Acute Form Total Score at Week 48 | 11.7 score on a scale | Standard Error 2.01 |
| Placebo + Semaglutide 2.4 mg | Change From Baseline in Quality of Life SF-36v2 Acute Form Total Score at Week 48 | 13.5 score on a scale | Standard Error 1.98 |
| Bimagrumab 10 mg/kg + Semaglutide 1.0 mg | Change From Baseline in Quality of Life SF-36v2 Acute Form Total Score at Week 48 | 14.8 score on a scale | Standard Error 2.16 |
| Bimagrumab 10 mg/kg + Semaglutide 2.4 mg | Change From Baseline in Quality of Life SF-36v2 Acute Form Total Score at Week 48 | 13.9 score on a scale | Standard Error 2.25 |
| Bimagrumab 30 mg/kg + Semaglutide 1.0 mg | Change From Baseline in Quality of Life SF-36v2 Acute Form Total Score at Week 48 | 14.4 score on a scale | Standard Error 2.31 |
| Bimagrumab 30 mg/kg + Semaglutide 2.4 mg | Change From Baseline in Quality of Life SF-36v2 Acute Form Total Score at Week 48 | 16.3 score on a scale | Standard Error 2.18 |
Secondary
Change From Baseline in Quality of Life SF-36v2 Acute Form Total Score Week 24
The SF-36 is a participant-reported outcome measure evaluating participant's health status. It comprises 36 items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. The 8 domains are regrouped into (mental component score \[MCS\] and physical componenet score \[PCS\] to obtain a total score ranging from 0 to 100, with higher scores indicating better levels of function and/or better health.
Time frame: Baseline, Week 24
Population: All randomized participants who received at least one dose of the study drug, had a baseline and at least one post- baseline value for this outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Quality of Life SF-36v2 Acute Form Total Score Week 24 | 6.577 score on a scale | Standard Deviation 13.194 |
| Bimagrumab 10 mg/kg | Change From Baseline in Quality of Life SF-36v2 Acute Form Total Score Week 24 | 4.086 score on a scale | Standard Deviation 13.219 |
| Bimagrumab 30 mg/kg | Change From Baseline in Quality of Life SF-36v2 Acute Form Total Score Week 24 | 12.193 score on a scale | Standard Deviation 13.711 |
| Placebo + Semaglutide 1.0 mg | Change From Baseline in Quality of Life SF-36v2 Acute Form Total Score Week 24 | 13.222 score on a scale | Standard Deviation 14.027 |
| Placebo + Semaglutide 2.4 mg | Change From Baseline in Quality of Life SF-36v2 Acute Form Total Score Week 24 | 11.153 score on a scale | Standard Deviation 12.357 |
| Bimagrumab 10 mg/kg + Semaglutide 1.0 mg | Change From Baseline in Quality of Life SF-36v2 Acute Form Total Score Week 24 | 12.124 score on a scale | Standard Deviation 16.235 |
| Bimagrumab 10 mg/kg + Semaglutide 2.4 mg | Change From Baseline in Quality of Life SF-36v2 Acute Form Total Score Week 24 | 7.484 score on a scale | Standard Deviation 14.917 |
| Bimagrumab 30 mg/kg + Semaglutide 1.0 mg | Change From Baseline in Quality of Life SF-36v2 Acute Form Total Score Week 24 | 11.506 score on a scale | Standard Deviation 13.528 |
| Bimagrumab 30 mg/kg + Semaglutide 2.4 mg | Change From Baseline in Quality of Life SF-36v2 Acute Form Total Score Week 24 | 17.060 score on a scale | Standard Deviation 13.523 |
Secondary
Change From Baseline in Quality of Life Short Form 36 Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score at Week 24
The SF-36v2 acute form assesses health-related quality of life (HRQoL) on 8 domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. The Physical-Functioning domain assesses limitations due to health now and consists of 10-items, each rated on a 3-point Likert scale. Scoring of the domain is norm-based and presented in the form of T-scores, with a mean of 50 and standard deviation of 10; higher scores indicate better levels of function. Range cannot be specified in norm-based scores.
Time frame: Baseline, Week 24
Population: All randomized participants who received at least one dose of the study drug, had a baseline and at least one post- baseline value for this outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Quality of Life Short Form 36 Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score at Week 24 | 7.162 t-score | Standard Deviation 13.72 |
| Bimagrumab 10 mg/kg | Change From Baseline in Quality of Life Short Form 36 Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score at Week 24 | 9.211 t-score | Standard Deviation 11.121 |
| Bimagrumab 30 mg/kg | Change From Baseline in Quality of Life Short Form 36 Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score at Week 24 | 14.342 t-score | Standard Deviation 14.15 |
| Placebo + Semaglutide 1.0 mg | Change From Baseline in Quality of Life Short Form 36 Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score at Week 24 | 12.500 t-score | Standard Deviation 15.23 |
| Placebo + Semaglutide 2.4 mg | Change From Baseline in Quality of Life Short Form 36 Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score at Week 24 | 10.435 t-score | Standard Deviation 14.826 |
| Bimagrumab 10 mg/kg + Semaglutide 1.0 mg | Change From Baseline in Quality of Life Short Form 36 Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score at Week 24 | 12.927 t-score | Standard Deviation 17.712 |
| Bimagrumab 10 mg/kg + Semaglutide 2.4 mg | Change From Baseline in Quality of Life Short Form 36 Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score at Week 24 | 9.265 t-score | Standard Deviation 15.132 |
| Bimagrumab 30 mg/kg + Semaglutide 1.0 mg | Change From Baseline in Quality of Life Short Form 36 Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score at Week 24 | 11.667 t-score | Standard Deviation 18.543 |
| Bimagrumab 30 mg/kg + Semaglutide 2.4 mg | Change From Baseline in Quality of Life Short Form 36 Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score at Week 24 | 17.222 t-score | Standard Deviation 19.619 |
Secondary
Change From Baseline in Total Body Fat Mass in kg at Week 72
Fat mass was obtained by DXA and was used to assess changes in body composition.
Time frame: Baseline, Week 72
Secondary
Change From Baseline in Total Body Fat Mass in Kilograms (kg) at Week 48
Fat mass was obtained by Dual energy X-ray absorptiometry (DXA) was used to assess changes in body composition. LS Mean was determined by ANCOVA model using Baseline + Gender (Male, Female) + Country (Australia, New Zealand, United States of America) + Treatment (Type III sum of squares) as variables. Only participants with non-missing baseline value were included in analysis. Missing values at Week 48 were imputed 100 times based on observed data in the Placebo arm.
Time frame: Baseline, Week 48
Population: All randomized participants who received at least one dose of the study drug, had a baseline and at least one post- baseline value for this outcome.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Total Body Fat Mass in Kilograms (kg) at Week 48 | -1.9 kg | Standard Error 1.18 |
| Bimagrumab 10 mg/kg | Change From Baseline in Total Body Fat Mass in Kilograms (kg) at Week 48 | -5.7 kg | Standard Error 1.19 |
| Bimagrumab 30 mg/kg | Change From Baseline in Total Body Fat Mass in Kilograms (kg) at Week 48 | -8.6 kg | Standard Error 1.15 |
| Placebo + Semaglutide 1.0 mg | Change From Baseline in Total Body Fat Mass in Kilograms (kg) at Week 48 | -6.7 kg | Standard Error 1.04 |
| Placebo + Semaglutide 2.4 mg | Change From Baseline in Total Body Fat Mass in Kilograms (kg) at Week 48 | -9.6 kg | Standard Error 1.02 |
| Bimagrumab 10 mg/kg + Semaglutide 1.0 mg | Change From Baseline in Total Body Fat Mass in Kilograms (kg) at Week 48 | -11.2 kg | Standard Error 1.11 |
| Bimagrumab 10 mg/kg + Semaglutide 2.4 mg | Change From Baseline in Total Body Fat Mass in Kilograms (kg) at Week 48 | -11.9 kg | Standard Error 1.11 |
| Bimagrumab 30 mg/kg + Semaglutide 1.0 mg | Change From Baseline in Total Body Fat Mass in Kilograms (kg) at Week 48 | -12.2 kg | Standard Error 1.08 |
| Bimagrumab 30 mg/kg + Semaglutide 2.4 mg | Change From Baseline in Total Body Fat Mass in Kilograms (kg) at Week 48 | -15.6 kg | Standard Error 1.04 |
Secondary
Change From Baseline in VAT, SAT and Trunk Fat Mass by DXA at Week 72
DXA was used to assess changes in body composition.
Time frame: Baseline, Week 72
Secondary
Change From Baseline in Visceral Adipose Tissue (VAT), Subcutaneous Adipose Tissue (SAT) and Trunk Fat Mass by DXA at Week 48
DXA was used to assess changes in body composition. LS Mean was determined by ANCOVA model using Baseline + Gender (Male, Female) + Country (Australia, New Zealand, United States of America) + Treatment (Type III sum of squares) as variables. Only participants with non-missing baseline value were included in analysis. Missing values at Week 48 were imputed 100 times based on observed data in the Placebo arm
Time frame: Baseline, Week 48
Population: All randomized participants who received at least one dose of the study drug, had a baseline and at least one post- baseline value for this outcome.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Visceral Adipose Tissue (VAT), Subcutaneous Adipose Tissue (SAT) and Trunk Fat Mass by DXA at Week 48 | SAT | -0.05 kg | Standard Error 0.1 |
| Placebo | Change From Baseline in Visceral Adipose Tissue (VAT), Subcutaneous Adipose Tissue (SAT) and Trunk Fat Mass by DXA at Week 48 | Trunk fat mass | -0.94 kg | Standard Error 0.72 |
| Placebo | Change From Baseline in Visceral Adipose Tissue (VAT), Subcutaneous Adipose Tissue (SAT) and Trunk Fat Mass by DXA at Week 48 | VAT | -0.0 kg | Standard Error 0.08 |
| Bimagrumab 10 mg/kg | Change From Baseline in Visceral Adipose Tissue (VAT), Subcutaneous Adipose Tissue (SAT) and Trunk Fat Mass by DXA at Week 48 | SAT | -0.37 kg | Standard Error 0.1 |
| Bimagrumab 10 mg/kg | Change From Baseline in Visceral Adipose Tissue (VAT), Subcutaneous Adipose Tissue (SAT) and Trunk Fat Mass by DXA at Week 48 | VAT | -0.3 kg | Standard Error 0.08 |
| Bimagrumab 10 mg/kg | Change From Baseline in Visceral Adipose Tissue (VAT), Subcutaneous Adipose Tissue (SAT) and Trunk Fat Mass by DXA at Week 48 | Trunk fat mass | -3.54 kg | Standard Error 0.72 |
| Bimagrumab 30 mg/kg | Change From Baseline in Visceral Adipose Tissue (VAT), Subcutaneous Adipose Tissue (SAT) and Trunk Fat Mass by DXA at Week 48 | Trunk fat mass | -5.44 kg | Standard Error 0.71 |
| Bimagrumab 30 mg/kg | Change From Baseline in Visceral Adipose Tissue (VAT), Subcutaneous Adipose Tissue (SAT) and Trunk Fat Mass by DXA at Week 48 | VAT | -0.4 kg | Standard Error 0.08 |
| Bimagrumab 30 mg/kg | Change From Baseline in Visceral Adipose Tissue (VAT), Subcutaneous Adipose Tissue (SAT) and Trunk Fat Mass by DXA at Week 48 | SAT | -0.54 kg | Standard Error 0.1 |
| Placebo + Semaglutide 1.0 mg | Change From Baseline in Visceral Adipose Tissue (VAT), Subcutaneous Adipose Tissue (SAT) and Trunk Fat Mass by DXA at Week 48 | SAT | -0.43 kg | Standard Error 0.09 |
| Placebo + Semaglutide 1.0 mg | Change From Baseline in Visceral Adipose Tissue (VAT), Subcutaneous Adipose Tissue (SAT) and Trunk Fat Mass by DXA at Week 48 | VAT | -0.3 kg | Standard Error 0.06 |
| Placebo + Semaglutide 1.0 mg | Change From Baseline in Visceral Adipose Tissue (VAT), Subcutaneous Adipose Tissue (SAT) and Trunk Fat Mass by DXA at Week 48 | Trunk fat mass | -3.83 kg | Standard Error 0.64 |
| Placebo + Semaglutide 2.4 mg | Change From Baseline in Visceral Adipose Tissue (VAT), Subcutaneous Adipose Tissue (SAT) and Trunk Fat Mass by DXA at Week 48 | SAT | -0.64 kg | Standard Error 0.09 |
| Placebo + Semaglutide 2.4 mg | Change From Baseline in Visceral Adipose Tissue (VAT), Subcutaneous Adipose Tissue (SAT) and Trunk Fat Mass by DXA at Week 48 | Trunk fat mass | -5.48 kg | Standard Error 0.63 |
| Placebo + Semaglutide 2.4 mg | Change From Baseline in Visceral Adipose Tissue (VAT), Subcutaneous Adipose Tissue (SAT) and Trunk Fat Mass by DXA at Week 48 | VAT | -0.4 kg | Standard Error 0.07 |
| Bimagrumab 10 mg/kg + Semaglutide 1.0 mg | Change From Baseline in Visceral Adipose Tissue (VAT), Subcutaneous Adipose Tissue (SAT) and Trunk Fat Mass by DXA at Week 48 | VAT | -0.5 kg | Standard Error 0.07 |
| Bimagrumab 10 mg/kg + Semaglutide 1.0 mg | Change From Baseline in Visceral Adipose Tissue (VAT), Subcutaneous Adipose Tissue (SAT) and Trunk Fat Mass by DXA at Week 48 | Trunk fat mass | -6.69 kg | Standard Error 0.65 |
| Bimagrumab 10 mg/kg + Semaglutide 1.0 mg | Change From Baseline in Visceral Adipose Tissue (VAT), Subcutaneous Adipose Tissue (SAT) and Trunk Fat Mass by DXA at Week 48 | SAT | -0.70 kg | Standard Error 0.09 |
| Bimagrumab 10 mg/kg + Semaglutide 2.4 mg | Change From Baseline in Visceral Adipose Tissue (VAT), Subcutaneous Adipose Tissue (SAT) and Trunk Fat Mass by DXA at Week 48 | Trunk fat mass | -7.46 kg | Standard Error 0.66 |
| Bimagrumab 10 mg/kg + Semaglutide 2.4 mg | Change From Baseline in Visceral Adipose Tissue (VAT), Subcutaneous Adipose Tissue (SAT) and Trunk Fat Mass by DXA at Week 48 | SAT | -0.84 kg | Standard Error 0.09 |
| Bimagrumab 10 mg/kg + Semaglutide 2.4 mg | Change From Baseline in Visceral Adipose Tissue (VAT), Subcutaneous Adipose Tissue (SAT) and Trunk Fat Mass by DXA at Week 48 | VAT | -0.6 kg | Standard Error 0.07 |
| Bimagrumab 30 mg/kg + Semaglutide 1.0 mg | Change From Baseline in Visceral Adipose Tissue (VAT), Subcutaneous Adipose Tissue (SAT) and Trunk Fat Mass by DXA at Week 48 | VAT | -0.6 kg | Standard Error 0.07 |
| Bimagrumab 30 mg/kg + Semaglutide 1.0 mg | Change From Baseline in Visceral Adipose Tissue (VAT), Subcutaneous Adipose Tissue (SAT) and Trunk Fat Mass by DXA at Week 48 | SAT | -0.81 kg | Standard Error 0.09 |
| Bimagrumab 30 mg/kg + Semaglutide 1.0 mg | Change From Baseline in Visceral Adipose Tissue (VAT), Subcutaneous Adipose Tissue (SAT) and Trunk Fat Mass by DXA at Week 48 | Trunk fat mass | -7.51 kg | Standard Error 0.65 |
| Bimagrumab 30 mg/kg + Semaglutide 2.4 mg | Change From Baseline in Visceral Adipose Tissue (VAT), Subcutaneous Adipose Tissue (SAT) and Trunk Fat Mass by DXA at Week 48 | VAT | -0.7 kg | Standard Error 0.07 |
| Bimagrumab 30 mg/kg + Semaglutide 2.4 mg | Change From Baseline in Visceral Adipose Tissue (VAT), Subcutaneous Adipose Tissue (SAT) and Trunk Fat Mass by DXA at Week 48 | Trunk fat mass | -9.19 kg | Standard Error 0.65 |
| Bimagrumab 30 mg/kg + Semaglutide 2.4 mg | Change From Baseline in Visceral Adipose Tissue (VAT), Subcutaneous Adipose Tissue (SAT) and Trunk Fat Mass by DXA at Week 48 | SAT | -1.05 kg | Standard Error 0.09 |
Secondary
Change From Baseline in Waist Circumference at Week 48
Waist circumference was measured in standing position with a non-stretchable measuring tape to the nearest 0.1 centimeter (cm). LS Mean was determined by ANCOVA model using Baseline + Gender (Male, Female) + Country (Australia, New Zealand, United States of America) + Treatment (Type III sum of squares) as variables. Only participants with non-missing baseline value were included in analysis. Missing values at Week 48 were imputed 100 times based on observed data in the Placebo arm.
Time frame: Baseline, Week 48
Population: All randomized participants who received at least one dose of the study drug, had a baseline and at least one post- baseline value for this outcome.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Waist Circumference at Week 48 | -4.62 centimeter (cm) | Standard Error 1.59 |
| Bimagrumab 10 mg/kg | Change From Baseline in Waist Circumference at Week 48 | -7.31 centimeter (cm) | Standard Error 1.74 |
| Bimagrumab 30 mg/kg | Change From Baseline in Waist Circumference at Week 48 | -9.10 centimeter (cm) | Standard Error 1.49 |
| Placebo + Semaglutide 1.0 mg | Change From Baseline in Waist Circumference at Week 48 | -8.74 centimeter (cm) | Standard Error 1.38 |
| Placebo + Semaglutide 2.4 mg | Change From Baseline in Waist Circumference at Week 48 | -12.14 centimeter (cm) | Standard Error 1.27 |
| Bimagrumab 10 mg/kg + Semaglutide 1.0 mg | Change From Baseline in Waist Circumference at Week 48 | -12.41 centimeter (cm) | Standard Error 1.48 |
| Bimagrumab 10 mg/kg + Semaglutide 2.4 mg | Change From Baseline in Waist Circumference at Week 48 | -13.35 centimeter (cm) | Standard Error 1.47 |
| Bimagrumab 30 mg/kg + Semaglutide 1.0 mg | Change From Baseline in Waist Circumference at Week 48 | -13.64 centimeter (cm) | Standard Error 1.42 |
| Bimagrumab 30 mg/kg + Semaglutide 2.4 mg | Change From Baseline in Waist Circumference at Week 48 | -15.78 centimeter (cm) | Standard Error 1.4 |
Secondary
Change From Baseline in Waist Circumference at Week 72
Waist circumference was measured in standing position with a non-stretchable measuring tape to the nearest 0.1 cm.
Time frame: Baseline, Week 72
Secondary
Percentage of Participants Achieving >5 kg Weight Loss and Fat Loss Index (FLI) of >70%, >80%, and >90% by DXA at Week 48
DXA was used to assess changes in body composition. FLI=% change in fat mass / % change in lean mass + % change in fat mass.
Time frame: Week 48
Population: All randomized participants who received at least one dose of the study drug and had evaluable data for this outcome.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Achieving >5 kg Weight Loss and Fat Loss Index (FLI) of >70%, >80%, and >90% by DXA at Week 48 | >5kg Weight Loss and Fat Loss Index >70 % | 14.55 percentage of participants |
| Placebo | Percentage of Participants Achieving >5 kg Weight Loss and Fat Loss Index (FLI) of >70%, >80%, and >90% by DXA at Week 48 | >5kg Weight Loss and Fat Loss Index >90 % | 3.64 percentage of participants |
| Placebo | Percentage of Participants Achieving >5 kg Weight Loss and Fat Loss Index (FLI) of >70%, >80%, and >90% by DXA at Week 48 | >5kg Weight Loss and Fat Loss Index >80 % | 12.73 percentage of participants |
| Bimagrumab 10 mg/kg | Percentage of Participants Achieving >5 kg Weight Loss and Fat Loss Index (FLI) of >70%, >80%, and >90% by DXA at Week 48 | >5kg Weight Loss and Fat Loss Index >80 % | 23.21 percentage of participants |
| Bimagrumab 10 mg/kg | Percentage of Participants Achieving >5 kg Weight Loss and Fat Loss Index (FLI) of >70%, >80%, and >90% by DXA at Week 48 | >5kg Weight Loss and Fat Loss Index >90 % | 19.64 percentage of participants |
| Bimagrumab 10 mg/kg | Percentage of Participants Achieving >5 kg Weight Loss and Fat Loss Index (FLI) of >70%, >80%, and >90% by DXA at Week 48 | >5kg Weight Loss and Fat Loss Index >70 % | 26.79 percentage of participants |
| Bimagrumab 30 mg/kg | Percentage of Participants Achieving >5 kg Weight Loss and Fat Loss Index (FLI) of >70%, >80%, and >90% by DXA at Week 48 | >5kg Weight Loss and Fat Loss Index >70 % | 40.35 percentage of participants |
| Bimagrumab 30 mg/kg | Percentage of Participants Achieving >5 kg Weight Loss and Fat Loss Index (FLI) of >70%, >80%, and >90% by DXA at Week 48 | >5kg Weight Loss and Fat Loss Index >80 % | 36.84 percentage of participants |
| Bimagrumab 30 mg/kg | Percentage of Participants Achieving >5 kg Weight Loss and Fat Loss Index (FLI) of >70%, >80%, and >90% by DXA at Week 48 | >5kg Weight Loss and Fat Loss Index >90 % | 35.09 percentage of participants |
| Placebo + Semaglutide 1.0 mg | Percentage of Participants Achieving >5 kg Weight Loss and Fat Loss Index (FLI) of >70%, >80%, and >90% by DXA at Week 48 | >5kg Weight Loss and Fat Loss Index >90 % | 12.73 percentage of participants |
| Placebo + Semaglutide 1.0 mg | Percentage of Participants Achieving >5 kg Weight Loss and Fat Loss Index (FLI) of >70%, >80%, and >90% by DXA at Week 48 | >5kg Weight Loss and Fat Loss Index >80 % | 16.36 percentage of participants |
| Placebo + Semaglutide 1.0 mg | Percentage of Participants Achieving >5 kg Weight Loss and Fat Loss Index (FLI) of >70%, >80%, and >90% by DXA at Week 48 | >5kg Weight Loss and Fat Loss Index >70 % | 41.82 percentage of participants |
| Placebo + Semaglutide 2.4 mg | Percentage of Participants Achieving >5 kg Weight Loss and Fat Loss Index (FLI) of >70%, >80%, and >90% by DXA at Week 48 | >5kg Weight Loss and Fat Loss Index >80 % | 17.86 percentage of participants |
| Placebo + Semaglutide 2.4 mg | Percentage of Participants Achieving >5 kg Weight Loss and Fat Loss Index (FLI) of >70%, >80%, and >90% by DXA at Week 48 | >5kg Weight Loss and Fat Loss Index >70 % | 50.00 percentage of participants |
| Placebo + Semaglutide 2.4 mg | Percentage of Participants Achieving >5 kg Weight Loss and Fat Loss Index (FLI) of >70%, >80%, and >90% by DXA at Week 48 | >5kg Weight Loss and Fat Loss Index >90 % | 5.36 percentage of participants |
| Bimagrumab 10 mg/kg + Semaglutide 1.0 mg | Percentage of Participants Achieving >5 kg Weight Loss and Fat Loss Index (FLI) of >70%, >80%, and >90% by DXA at Week 48 | >5kg Weight Loss and Fat Loss Index >80 % | 57.14 percentage of participants |
| Bimagrumab 10 mg/kg + Semaglutide 1.0 mg | Percentage of Participants Achieving >5 kg Weight Loss and Fat Loss Index (FLI) of >70%, >80%, and >90% by DXA at Week 48 | >5kg Weight Loss and Fat Loss Index >70 % | 62.50 percentage of participants |
| Bimagrumab 10 mg/kg + Semaglutide 1.0 mg | Percentage of Participants Achieving >5 kg Weight Loss and Fat Loss Index (FLI) of >70%, >80%, and >90% by DXA at Week 48 | >5kg Weight Loss and Fat Loss Index >90 % | 42.86 percentage of participants |
| Bimagrumab 10 mg/kg + Semaglutide 2.4 mg | Percentage of Participants Achieving >5 kg Weight Loss and Fat Loss Index (FLI) of >70%, >80%, and >90% by DXA at Week 48 | >5kg Weight Loss and Fat Loss Index >80 % | 56.36 percentage of participants |
| Bimagrumab 10 mg/kg + Semaglutide 2.4 mg | Percentage of Participants Achieving >5 kg Weight Loss and Fat Loss Index (FLI) of >70%, >80%, and >90% by DXA at Week 48 | >5kg Weight Loss and Fat Loss Index >70 % | 65.45 percentage of participants |
| Bimagrumab 10 mg/kg + Semaglutide 2.4 mg | Percentage of Participants Achieving >5 kg Weight Loss and Fat Loss Index (FLI) of >70%, >80%, and >90% by DXA at Week 48 | >5kg Weight Loss and Fat Loss Index >90 % | 41.82 percentage of participants |
| Bimagrumab 30 mg/kg + Semaglutide 1.0 mg | Percentage of Participants Achieving >5 kg Weight Loss and Fat Loss Index (FLI) of >70%, >80%, and >90% by DXA at Week 48 | >5kg Weight Loss and Fat Loss Index >80 % | 53.57 percentage of participants |
| Bimagrumab 30 mg/kg + Semaglutide 1.0 mg | Percentage of Participants Achieving >5 kg Weight Loss and Fat Loss Index (FLI) of >70%, >80%, and >90% by DXA at Week 48 | >5kg Weight Loss and Fat Loss Index >70 % | 64.29 percentage of participants |
| Bimagrumab 30 mg/kg + Semaglutide 1.0 mg | Percentage of Participants Achieving >5 kg Weight Loss and Fat Loss Index (FLI) of >70%, >80%, and >90% by DXA at Week 48 | >5kg Weight Loss and Fat Loss Index >90 % | 46.43 percentage of participants |
| Bimagrumab 30 mg/kg + Semaglutide 2.4 mg | Percentage of Participants Achieving >5 kg Weight Loss and Fat Loss Index (FLI) of >70%, >80%, and >90% by DXA at Week 48 | >5kg Weight Loss and Fat Loss Index >70 % | 72.73 percentage of participants |
| Bimagrumab 30 mg/kg + Semaglutide 2.4 mg | Percentage of Participants Achieving >5 kg Weight Loss and Fat Loss Index (FLI) of >70%, >80%, and >90% by DXA at Week 48 | >5kg Weight Loss and Fat Loss Index >80 % | 61.82 percentage of participants |
| Bimagrumab 30 mg/kg + Semaglutide 2.4 mg | Percentage of Participants Achieving >5 kg Weight Loss and Fat Loss Index (FLI) of >70%, >80%, and >90% by DXA at Week 48 | >5kg Weight Loss and Fat Loss Index >90 % | 41.82 percentage of participants |
Secondary
Percentage of Participants With Baseline Waist-to-Height Ratio (WtHR) Category of <0.5 Having Change From Baseline in Waist-to-Height Ratio (WHtR Ratio) Categories at Week 48
WHtR ratio categories: \<0.5; 0.5-0.59; ≥0.6
Time frame: Baseline up to 48 weeks
Population: All randomized participants who received at least one dose of the study drug and had a baseline WtHR category \<0.5 and had evaluable data at week 48.~As no enrolled participants had a baseline waist-to-height ratio (WtHR) below 0.5, this outcome measure was not analyzed, and no participants were included in the analysis.
| Arm | Measure | Group | Value |
|---|---|---|---|
| Unknown | Percentage of Participants With Baseline Waist-to-Height Ratio (WtHR) Category of <0.5 Having Change From Baseline in Waist-to-Height Ratio (WHtR Ratio) Categories at Week 48 | WtHR Category: <0.5 | — |
| Unknown | Percentage of Participants With Baseline Waist-to-Height Ratio (WtHR) Category of <0.5 Having Change From Baseline in Waist-to-Height Ratio (WHtR Ratio) Categories at Week 48 | WtHR Category: 0.5-0.59 | — |
| Unknown | Percentage of Participants With Baseline Waist-to-Height Ratio (WtHR) Category of <0.5 Having Change From Baseline in Waist-to-Height Ratio (WHtR Ratio) Categories at Week 48 | WtHR Category: ≥0.6 | — |
Secondary
Percentage of Participants With Baseline WtHR Category ≥0.6 Having Change From Baseline in Waist-to-Height Ratio (WHtR Ratio) Categories at Week 48
WHtR ratio categories: \<0.5; 0.5-0.59; ≥0.6
Time frame: Baseline up to 48 weeks
Population: All randomized participants who received at least one dose of the study drug and had Baseline WtHR Category ≥0.6 and had evaluable data at week 48
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With Baseline WtHR Category ≥0.6 Having Change From Baseline in Waist-to-Height Ratio (WHtR Ratio) Categories at Week 48 | WtHR Category: <0.5 | 0 percentage of participants |
| Placebo | Percentage of Participants With Baseline WtHR Category ≥0.6 Having Change From Baseline in Waist-to-Height Ratio (WHtR Ratio) Categories at Week 48 | WtHR Category: ≥0.6 | 80.0 percentage of participants |
| Placebo | Percentage of Participants With Baseline WtHR Category ≥0.6 Having Change From Baseline in Waist-to-Height Ratio (WHtR Ratio) Categories at Week 48 | WtHR Category: 0.5-0.59 | 20.0 percentage of participants |
| Bimagrumab 10 mg/kg | Percentage of Participants With Baseline WtHR Category ≥0.6 Having Change From Baseline in Waist-to-Height Ratio (WHtR Ratio) Categories at Week 48 | WtHR Category: ≥0.6 | 82.1 percentage of participants |
| Bimagrumab 10 mg/kg | Percentage of Participants With Baseline WtHR Category ≥0.6 Having Change From Baseline in Waist-to-Height Ratio (WHtR Ratio) Categories at Week 48 | WtHR Category: 0.5-0.59 | 17.9 percentage of participants |
| Bimagrumab 10 mg/kg | Percentage of Participants With Baseline WtHR Category ≥0.6 Having Change From Baseline in Waist-to-Height Ratio (WHtR Ratio) Categories at Week 48 | WtHR Category: <0.5 | 0 percentage of participants |
| Bimagrumab 30 mg/kg | Percentage of Participants With Baseline WtHR Category ≥0.6 Having Change From Baseline in Waist-to-Height Ratio (WHtR Ratio) Categories at Week 48 | WtHR Category: 0.5-0.59 | 21.6 percentage of participants |
| Bimagrumab 30 mg/kg | Percentage of Participants With Baseline WtHR Category ≥0.6 Having Change From Baseline in Waist-to-Height Ratio (WHtR Ratio) Categories at Week 48 | WtHR Category: <0.5 | 5.4 percentage of participants |
| Bimagrumab 30 mg/kg | Percentage of Participants With Baseline WtHR Category ≥0.6 Having Change From Baseline in Waist-to-Height Ratio (WHtR Ratio) Categories at Week 48 | WtHR Category: ≥0.6 | 73.0 percentage of participants |
| Placebo + Semaglutide 1.0 mg | Percentage of Participants With Baseline WtHR Category ≥0.6 Having Change From Baseline in Waist-to-Height Ratio (WHtR Ratio) Categories at Week 48 | WtHR Category: ≥0.6 | 71.8 percentage of participants |
| Placebo + Semaglutide 1.0 mg | Percentage of Participants With Baseline WtHR Category ≥0.6 Having Change From Baseline in Waist-to-Height Ratio (WHtR Ratio) Categories at Week 48 | WtHR Category: <0.5 | 2.6 percentage of participants |
| Placebo + Semaglutide 1.0 mg | Percentage of Participants With Baseline WtHR Category ≥0.6 Having Change From Baseline in Waist-to-Height Ratio (WHtR Ratio) Categories at Week 48 | WtHR Category: 0.5-0.59 | 25.6 percentage of participants |
| Placebo + Semaglutide 2.4 mg | Percentage of Participants With Baseline WtHR Category ≥0.6 Having Change From Baseline in Waist-to-Height Ratio (WHtR Ratio) Categories at Week 48 | WtHR Category: 0.5-0.59 | 31.3 percentage of participants |
| Placebo + Semaglutide 2.4 mg | Percentage of Participants With Baseline WtHR Category ≥0.6 Having Change From Baseline in Waist-to-Height Ratio (WHtR Ratio) Categories at Week 48 | WtHR Category: <0.5 | 2.1 percentage of participants |
| Placebo + Semaglutide 2.4 mg | Percentage of Participants With Baseline WtHR Category ≥0.6 Having Change From Baseline in Waist-to-Height Ratio (WHtR Ratio) Categories at Week 48 | WtHR Category: ≥0.6 | 66.7 percentage of participants |
| Bimagrumab 10 mg/kg + Semaglutide 1.0 mg | Percentage of Participants With Baseline WtHR Category ≥0.6 Having Change From Baseline in Waist-to-Height Ratio (WHtR Ratio) Categories at Week 48 | WtHR Category: 0.5-0.59 | 38.5 percentage of participants |
| Bimagrumab 10 mg/kg + Semaglutide 1.0 mg | Percentage of Participants With Baseline WtHR Category ≥0.6 Having Change From Baseline in Waist-to-Height Ratio (WHtR Ratio) Categories at Week 48 | WtHR Category: <0.5 | 0 percentage of participants |
| Bimagrumab 10 mg/kg + Semaglutide 1.0 mg | Percentage of Participants With Baseline WtHR Category ≥0.6 Having Change From Baseline in Waist-to-Height Ratio (WHtR Ratio) Categories at Week 48 | WtHR Category: ≥0.6 | 61.5 percentage of participants |
| Bimagrumab 10 mg/kg + Semaglutide 2.4 mg | Percentage of Participants With Baseline WtHR Category ≥0.6 Having Change From Baseline in Waist-to-Height Ratio (WHtR Ratio) Categories at Week 48 | WtHR Category: ≥0.6 | 53.8 percentage of participants |
| Bimagrumab 10 mg/kg + Semaglutide 2.4 mg | Percentage of Participants With Baseline WtHR Category ≥0.6 Having Change From Baseline in Waist-to-Height Ratio (WHtR Ratio) Categories at Week 48 | WtHR Category: <0.5 | 7.7 percentage of participants |
| Bimagrumab 10 mg/kg + Semaglutide 2.4 mg | Percentage of Participants With Baseline WtHR Category ≥0.6 Having Change From Baseline in Waist-to-Height Ratio (WHtR Ratio) Categories at Week 48 | WtHR Category: 0.5-0.59 | 38.5 percentage of participants |
| Bimagrumab 30 mg/kg + Semaglutide 1.0 mg | Percentage of Participants With Baseline WtHR Category ≥0.6 Having Change From Baseline in Waist-to-Height Ratio (WHtR Ratio) Categories at Week 48 | WtHR Category: 0.5-0.59 | 51.2 percentage of participants |
| Bimagrumab 30 mg/kg + Semaglutide 1.0 mg | Percentage of Participants With Baseline WtHR Category ≥0.6 Having Change From Baseline in Waist-to-Height Ratio (WHtR Ratio) Categories at Week 48 | WtHR Category: ≥0.6 | 46.5 percentage of participants |
| Bimagrumab 30 mg/kg + Semaglutide 1.0 mg | Percentage of Participants With Baseline WtHR Category ≥0.6 Having Change From Baseline in Waist-to-Height Ratio (WHtR Ratio) Categories at Week 48 | WtHR Category: <0.5 | 2.3 percentage of participants |
| Bimagrumab 30 mg/kg + Semaglutide 2.4 mg | Percentage of Participants With Baseline WtHR Category ≥0.6 Having Change From Baseline in Waist-to-Height Ratio (WHtR Ratio) Categories at Week 48 | WtHR Category: 0.5-0.59 | 35.9 percentage of participants |
| Bimagrumab 30 mg/kg + Semaglutide 2.4 mg | Percentage of Participants With Baseline WtHR Category ≥0.6 Having Change From Baseline in Waist-to-Height Ratio (WHtR Ratio) Categories at Week 48 | WtHR Category: ≥0.6 | 48.7 percentage of participants |
| Bimagrumab 30 mg/kg + Semaglutide 2.4 mg | Percentage of Participants With Baseline WtHR Category ≥0.6 Having Change From Baseline in Waist-to-Height Ratio (WHtR Ratio) Categories at Week 48 | WtHR Category: <0.5 | 15.4 percentage of participants |
Secondary
Percentage of Participants With Baseline WtHR Category of 0.5-0.59 Having Change From Baseline in Waist-to-Height Ratio (WHtR Ratio) Categories at Week 48
WHtR ratio categories: \<0.5; 0.5-0.59; ≥0.6
Time frame: Baseline up to 48 weeks
Population: All randomized participants who received at least one dose of the study drug and had Baseline WtHR Category 0.5-0.59 and had evaluable data at week 48.~No participants were included in the analysis for the Bimagrumab 30 mg/kg, Bimagrumab 10 mg/kg + semaglutide 2.4 mg, and Bimagrumab 30 mg/kg + semaglutide 1.0 mg reporting arms, as none of the enrolled individuals in these groups had a baseline WtHR of 0.5-0.59.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With Baseline WtHR Category of 0.5-0.59 Having Change From Baseline in Waist-to-Height Ratio (WHtR Ratio) Categories at Week 48 | WtHR Category: 0.5-0.59 | 60.0 percentage of participants |
| Placebo | Percentage of Participants With Baseline WtHR Category of 0.5-0.59 Having Change From Baseline in Waist-to-Height Ratio (WHtR Ratio) Categories at Week 48 | WtHR Category: <0.5 | 0 percentage of participants |
| Placebo | Percentage of Participants With Baseline WtHR Category of 0.5-0.59 Having Change From Baseline in Waist-to-Height Ratio (WHtR Ratio) Categories at Week 48 | WtHR Category: ≥0.6 | 40.0 percentage of participants |
| Bimagrumab 10 mg/kg | Percentage of Participants With Baseline WtHR Category of 0.5-0.59 Having Change From Baseline in Waist-to-Height Ratio (WHtR Ratio) Categories at Week 48 | WtHR Category: 0.5-0.59 | 100.0 percentage of participants |
| Bimagrumab 10 mg/kg | Percentage of Participants With Baseline WtHR Category of 0.5-0.59 Having Change From Baseline in Waist-to-Height Ratio (WHtR Ratio) Categories at Week 48 | WtHR Category: <0.5 | 0 percentage of participants |
| Bimagrumab 10 mg/kg | Percentage of Participants With Baseline WtHR Category of 0.5-0.59 Having Change From Baseline in Waist-to-Height Ratio (WHtR Ratio) Categories at Week 48 | WtHR Category: ≥0.6 | 0 percentage of participants |
| Placebo + Semaglutide 1.0 mg | Percentage of Participants With Baseline WtHR Category of 0.5-0.59 Having Change From Baseline in Waist-to-Height Ratio (WHtR Ratio) Categories at Week 48 | WtHR Category: 0.5-0.59 | 50.0 percentage of participants |
| Placebo + Semaglutide 1.0 mg | Percentage of Participants With Baseline WtHR Category of 0.5-0.59 Having Change From Baseline in Waist-to-Height Ratio (WHtR Ratio) Categories at Week 48 | WtHR Category: <0.5 | 50.0 percentage of participants |
| Placebo + Semaglutide 1.0 mg | Percentage of Participants With Baseline WtHR Category of 0.5-0.59 Having Change From Baseline in Waist-to-Height Ratio (WHtR Ratio) Categories at Week 48 | WtHR Category: ≥0.6 | 0 percentage of participants |
| Placebo + Semaglutide 2.4 mg | Percentage of Participants With Baseline WtHR Category of 0.5-0.59 Having Change From Baseline in Waist-to-Height Ratio (WHtR Ratio) Categories at Week 48 | WtHR Category: 0.5-0.59 | 66.7 percentage of participants |
| Placebo + Semaglutide 2.4 mg | Percentage of Participants With Baseline WtHR Category of 0.5-0.59 Having Change From Baseline in Waist-to-Height Ratio (WHtR Ratio) Categories at Week 48 | WtHR Category: <0.5 | 0 percentage of participants |
| Placebo + Semaglutide 2.4 mg | Percentage of Participants With Baseline WtHR Category of 0.5-0.59 Having Change From Baseline in Waist-to-Height Ratio (WHtR Ratio) Categories at Week 48 | WtHR Category: ≥0.6 | 33.3 percentage of participants |
| Bimagrumab 10 mg/kg + Semaglutide 1.0 mg | Percentage of Participants With Baseline WtHR Category of 0.5-0.59 Having Change From Baseline in Waist-to-Height Ratio (WHtR Ratio) Categories at Week 48 | WtHR Category: 0.5-0.59 | 100.0 percentage of participants |
| Bimagrumab 10 mg/kg + Semaglutide 1.0 mg | Percentage of Participants With Baseline WtHR Category of 0.5-0.59 Having Change From Baseline in Waist-to-Height Ratio (WHtR Ratio) Categories at Week 48 | WtHR Category: <0.5 | 0 percentage of participants |
| Bimagrumab 10 mg/kg + Semaglutide 1.0 mg | Percentage of Participants With Baseline WtHR Category of 0.5-0.59 Having Change From Baseline in Waist-to-Height Ratio (WHtR Ratio) Categories at Week 48 | WtHR Category: ≥0.6 | 0 percentage of participants |
| Bimagrumab 30 mg/kg + Semaglutide 2.4 mg | Percentage of Participants With Baseline WtHR Category of 0.5-0.59 Having Change From Baseline in Waist-to-Height Ratio (WHtR Ratio) Categories at Week 48 | WtHR Category: <0.5 | 25.0 percentage of participants |
| Bimagrumab 30 mg/kg + Semaglutide 2.4 mg | Percentage of Participants With Baseline WtHR Category of 0.5-0.59 Having Change From Baseline in Waist-to-Height Ratio (WHtR Ratio) Categories at Week 48 | WtHR Category: ≥0.6 | 0 percentage of participants |
| Bimagrumab 30 mg/kg + Semaglutide 2.4 mg | Percentage of Participants With Baseline WtHR Category of 0.5-0.59 Having Change From Baseline in Waist-to-Height Ratio (WHtR Ratio) Categories at Week 48 | WtHR Category: 0.5-0.59 | 75.0 percentage of participants |
Secondary
Percentage of Participants With Body Mass Index (BMI) Categories at Baseline and Week 48
BMI categories: i. Healthy weight: 18.5 kilograms (kg)/meter (m)² to 24.9 kg/m² ii. Overweight: 25 kg/m² to 29.9 kg/m² iii. Obesity class 1: 30 kg/m² to 34.9 kg/m² iv. Obesity class II: 35 kg/m² to 39.9 kg/m² v. Obesity class III: ≥ 40 kg/m2
Time frame: Baseline, Week 48
Population: All randomized participants who received at least one dose of the study drug and had evaluable data for this outcome.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With Body Mass Index (BMI) Categories at Baseline and Week 48 | Obesity class II (Baseline) | 40 percentage of participants |
| Placebo | Percentage of Participants With Body Mass Index (BMI) Categories at Baseline and Week 48 | Healthy weight (Baseline) | 0 percentage of participants |
| Placebo | Percentage of Participants With Body Mass Index (BMI) Categories at Baseline and Week 48 | Obesity class II (Week 48) | 31.4 percentage of participants |
| Placebo | Percentage of Participants With Body Mass Index (BMI) Categories at Baseline and Week 48 | Overweight (Week 48) | 11.4 percentage of participants |
| Placebo | Percentage of Participants With Body Mass Index (BMI) Categories at Baseline and Week 48 | Obesity class III (Week 48) | 20 percentage of participants |
| Placebo | Percentage of Participants With Body Mass Index (BMI) Categories at Baseline and Week 48 | Healthy weight (Week 48) | 0 percentage of participants |
| Placebo | Percentage of Participants With Body Mass Index (BMI) Categories at Baseline and Week 48 | Obesity class I (Week 48) | 37.1 percentage of participants |
| Placebo | Percentage of Participants With Body Mass Index (BMI) Categories at Baseline and Week 48 | Obesity class III (Baseline) | 29.1 percentage of participants |
| Placebo | Percentage of Participants With Body Mass Index (BMI) Categories at Baseline and Week 48 | Obesity class I (Baseline) | 29.1 percentage of participants |
| Placebo | Percentage of Participants With Body Mass Index (BMI) Categories at Baseline and Week 48 | Overweight (Baseline) | 1.8 percentage of participants |
| Bimagrumab 10 mg/kg | Percentage of Participants With Body Mass Index (BMI) Categories at Baseline and Week 48 | Obesity class I (Baseline) | 39.3 percentage of participants |
| Bimagrumab 10 mg/kg | Percentage of Participants With Body Mass Index (BMI) Categories at Baseline and Week 48 | Obesity class II (Baseline) | 30.4 percentage of participants |
| Bimagrumab 10 mg/kg | Percentage of Participants With Body Mass Index (BMI) Categories at Baseline and Week 48 | Obesity class III (Week 48) | 12.9 percentage of participants |
| Bimagrumab 10 mg/kg | Percentage of Participants With Body Mass Index (BMI) Categories at Baseline and Week 48 | Obesity class II (Week 48) | 35.5 percentage of participants |
| Bimagrumab 10 mg/kg | Percentage of Participants With Body Mass Index (BMI) Categories at Baseline and Week 48 | Obesity class I (Week 48) | 32.3 percentage of participants |
| Bimagrumab 10 mg/kg | Percentage of Participants With Body Mass Index (BMI) Categories at Baseline and Week 48 | Overweight (Baseline) | 5.4 percentage of participants |
| Bimagrumab 10 mg/kg | Percentage of Participants With Body Mass Index (BMI) Categories at Baseline and Week 48 | Overweight (Week 48) | 19.4 percentage of participants |
| Bimagrumab 10 mg/kg | Percentage of Participants With Body Mass Index (BMI) Categories at Baseline and Week 48 | Healthy weight (Week 48) | 0 percentage of participants |
| Bimagrumab 10 mg/kg | Percentage of Participants With Body Mass Index (BMI) Categories at Baseline and Week 48 | Obesity class III (Baseline) | 25 percentage of participants |
| Bimagrumab 10 mg/kg | Percentage of Participants With Body Mass Index (BMI) Categories at Baseline and Week 48 | Healthy weight (Baseline) | 0 percentage of participants |
| Bimagrumab 30 mg/kg | Percentage of Participants With Body Mass Index (BMI) Categories at Baseline and Week 48 | Overweight (Baseline) | 1.8 percentage of participants |
| Bimagrumab 30 mg/kg | Percentage of Participants With Body Mass Index (BMI) Categories at Baseline and Week 48 | Healthy weight (Baseline) | 0 percentage of participants |
| Bimagrumab 30 mg/kg | Percentage of Participants With Body Mass Index (BMI) Categories at Baseline and Week 48 | Obesity class I (Baseline) | 29.8 percentage of participants |
| Bimagrumab 30 mg/kg | Percentage of Participants With Body Mass Index (BMI) Categories at Baseline and Week 48 | Obesity class II (Baseline) | 38.6 percentage of participants |
| Bimagrumab 30 mg/kg | Percentage of Participants With Body Mass Index (BMI) Categories at Baseline and Week 48 | Obesity class III (Baseline) | 29.8 percentage of participants |
| Bimagrumab 30 mg/kg | Percentage of Participants With Body Mass Index (BMI) Categories at Baseline and Week 48 | Healthy weight (Week 48) | 2.7 percentage of participants |
| Bimagrumab 30 mg/kg | Percentage of Participants With Body Mass Index (BMI) Categories at Baseline and Week 48 | Overweight (Week 48) | 21.6 percentage of participants |
| Bimagrumab 30 mg/kg | Percentage of Participants With Body Mass Index (BMI) Categories at Baseline and Week 48 | Obesity class I (Week 48) | 43.2 percentage of participants |
| Bimagrumab 30 mg/kg | Percentage of Participants With Body Mass Index (BMI) Categories at Baseline and Week 48 | Obesity class II (Week 48) | 21.6 percentage of participants |
| Bimagrumab 30 mg/kg | Percentage of Participants With Body Mass Index (BMI) Categories at Baseline and Week 48 | Obesity class III (Week 48) | 10.8 percentage of participants |
| Placebo + Semaglutide 1.0 mg | Percentage of Participants With Body Mass Index (BMI) Categories at Baseline and Week 48 | Overweight (Week 48) | 28.9 percentage of participants |
| Placebo + Semaglutide 1.0 mg | Percentage of Participants With Body Mass Index (BMI) Categories at Baseline and Week 48 | Obesity class I (Baseline) | 27.3 percentage of participants |
| Placebo + Semaglutide 1.0 mg | Percentage of Participants With Body Mass Index (BMI) Categories at Baseline and Week 48 | Healthy weight (Week 48) | 17.8 percentage of participants |
| Placebo + Semaglutide 1.0 mg | Percentage of Participants With Body Mass Index (BMI) Categories at Baseline and Week 48 | Obesity class I (Week 48) | 17.8 percentage of participants |
| Placebo + Semaglutide 1.0 mg | Percentage of Participants With Body Mass Index (BMI) Categories at Baseline and Week 48 | Obesity class II (Baseline) | 27.3 percentage of participants |
| Placebo + Semaglutide 1.0 mg | Percentage of Participants With Body Mass Index (BMI) Categories at Baseline and Week 48 | Overweight (Baseline) | 14.5 percentage of participants |
| Placebo + Semaglutide 1.0 mg | Percentage of Participants With Body Mass Index (BMI) Categories at Baseline and Week 48 | Obesity class II (Week 48) | 17.8 percentage of participants |
| Placebo + Semaglutide 1.0 mg | Percentage of Participants With Body Mass Index (BMI) Categories at Baseline and Week 48 | Healthy weight (Baseline) | 0 percentage of participants |
| Placebo + Semaglutide 1.0 mg | Percentage of Participants With Body Mass Index (BMI) Categories at Baseline and Week 48 | Obesity class III (Week 48) | 17.8 percentage of participants |
| Placebo + Semaglutide 1.0 mg | Percentage of Participants With Body Mass Index (BMI) Categories at Baseline and Week 48 | Obesity class III (Baseline) | 30.9 percentage of participants |
| Placebo + Semaglutide 2.4 mg | Percentage of Participants With Body Mass Index (BMI) Categories at Baseline and Week 48 | Obesity class II (Baseline) | 32.1 percentage of participants |
| Placebo + Semaglutide 2.4 mg | Percentage of Participants With Body Mass Index (BMI) Categories at Baseline and Week 48 | Obesity class I (Week 48) | 51.0 percentage of participants |
| Placebo + Semaglutide 2.4 mg | Percentage of Participants With Body Mass Index (BMI) Categories at Baseline and Week 48 | Obesity class I (Baseline) | 35.7 percentage of participants |
| Placebo + Semaglutide 2.4 mg | Percentage of Participants With Body Mass Index (BMI) Categories at Baseline and Week 48 | Obesity class III (Baseline) | 26.8 percentage of participants |
| Placebo + Semaglutide 2.4 mg | Percentage of Participants With Body Mass Index (BMI) Categories at Baseline and Week 48 | Healthy weight (Baseline) | 0 percentage of participants |
| Placebo + Semaglutide 2.4 mg | Percentage of Participants With Body Mass Index (BMI) Categories at Baseline and Week 48 | Obesity class III (Week 48) | 3.9 percentage of participants |
| Placebo + Semaglutide 2.4 mg | Percentage of Participants With Body Mass Index (BMI) Categories at Baseline and Week 48 | Healthy weight (Week 48) | 3.9 percentage of participants |
| Placebo + Semaglutide 2.4 mg | Percentage of Participants With Body Mass Index (BMI) Categories at Baseline and Week 48 | Obesity class II (Week 48) | 7.8 percentage of participants |
| Placebo + Semaglutide 2.4 mg | Percentage of Participants With Body Mass Index (BMI) Categories at Baseline and Week 48 | Overweight (Baseline) | 5.4 percentage of participants |
| Placebo + Semaglutide 2.4 mg | Percentage of Participants With Body Mass Index (BMI) Categories at Baseline and Week 48 | Overweight (Week 48) | 33.3 percentage of participants |
| Bimagrumab 10 mg/kg + Semaglutide 1.0 mg | Percentage of Participants With Body Mass Index (BMI) Categories at Baseline and Week 48 | Healthy weight (Week 48) | 2.4 percentage of participants |
| Bimagrumab 10 mg/kg + Semaglutide 1.0 mg | Percentage of Participants With Body Mass Index (BMI) Categories at Baseline and Week 48 | Obesity class III (Baseline) | 37.5 percentage of participants |
| Bimagrumab 10 mg/kg + Semaglutide 1.0 mg | Percentage of Participants With Body Mass Index (BMI) Categories at Baseline and Week 48 | Healthy weight (Baseline) | 0 percentage of participants |
| Bimagrumab 10 mg/kg + Semaglutide 1.0 mg | Percentage of Participants With Body Mass Index (BMI) Categories at Baseline and Week 48 | Obesity class I (Baseline) | 28.6 percentage of participants |
| Bimagrumab 10 mg/kg + Semaglutide 1.0 mg | Percentage of Participants With Body Mass Index (BMI) Categories at Baseline and Week 48 | Overweight (Week 48) | 31.7 percentage of participants |
| Bimagrumab 10 mg/kg + Semaglutide 1.0 mg | Percentage of Participants With Body Mass Index (BMI) Categories at Baseline and Week 48 | Obesity class II (Week 48) | 26.8 percentage of participants |
| Bimagrumab 10 mg/kg + Semaglutide 1.0 mg | Percentage of Participants With Body Mass Index (BMI) Categories at Baseline and Week 48 | Overweight (Baseline) | 3.6 percentage of participants |
| Bimagrumab 10 mg/kg + Semaglutide 1.0 mg | Percentage of Participants With Body Mass Index (BMI) Categories at Baseline and Week 48 | Obesity class I (Week 48) | 31.7 percentage of participants |
| Bimagrumab 10 mg/kg + Semaglutide 1.0 mg | Percentage of Participants With Body Mass Index (BMI) Categories at Baseline and Week 48 | Obesity class II (Baseline) | 30.4 percentage of participants |
| Bimagrumab 10 mg/kg + Semaglutide 1.0 mg | Percentage of Participants With Body Mass Index (BMI) Categories at Baseline and Week 48 | Obesity class III (Week 48) | 7.3 percentage of participants |
| Bimagrumab 10 mg/kg + Semaglutide 2.4 mg | Percentage of Participants With Body Mass Index (BMI) Categories at Baseline and Week 48 | Overweight (Week 48) | 25 percentage of participants |
| Bimagrumab 10 mg/kg + Semaglutide 2.4 mg | Percentage of Participants With Body Mass Index (BMI) Categories at Baseline and Week 48 | Obesity class II (Baseline) | 29.1 percentage of participants |
| Bimagrumab 10 mg/kg + Semaglutide 2.4 mg | Percentage of Participants With Body Mass Index (BMI) Categories at Baseline and Week 48 | Obesity class III (Baseline) | 34.5 percentage of participants |
| Bimagrumab 10 mg/kg + Semaglutide 2.4 mg | Percentage of Participants With Body Mass Index (BMI) Categories at Baseline and Week 48 | Overweight (Baseline) | 9.1 percentage of participants |
| Bimagrumab 10 mg/kg + Semaglutide 2.4 mg | Percentage of Participants With Body Mass Index (BMI) Categories at Baseline and Week 48 | Healthy weight (Week 48) | 10 percentage of participants |
| Bimagrumab 10 mg/kg + Semaglutide 2.4 mg | Percentage of Participants With Body Mass Index (BMI) Categories at Baseline and Week 48 | Obesity class III (Week 48) | 5 percentage of participants |
| Bimagrumab 10 mg/kg + Semaglutide 2.4 mg | Percentage of Participants With Body Mass Index (BMI) Categories at Baseline and Week 48 | Obesity class I (Week 48) | 37.5 percentage of participants |
| Bimagrumab 10 mg/kg + Semaglutide 2.4 mg | Percentage of Participants With Body Mass Index (BMI) Categories at Baseline and Week 48 | Healthy weight (Baseline) | 0 percentage of participants |
| Bimagrumab 10 mg/kg + Semaglutide 2.4 mg | Percentage of Participants With Body Mass Index (BMI) Categories at Baseline and Week 48 | Obesity class II (Week 48) | 22.5 percentage of participants |
| Bimagrumab 10 mg/kg + Semaglutide 2.4 mg | Percentage of Participants With Body Mass Index (BMI) Categories at Baseline and Week 48 | Obesity class I (Baseline) | 27.3 percentage of participants |
| Bimagrumab 30 mg/kg + Semaglutide 1.0 mg | Percentage of Participants With Body Mass Index (BMI) Categories at Baseline and Week 48 | Overweight (Week 48) | 25.6 percentage of participants |
| Bimagrumab 30 mg/kg + Semaglutide 1.0 mg | Percentage of Participants With Body Mass Index (BMI) Categories at Baseline and Week 48 | Obesity class III (Baseline) | 23.2 percentage of participants |
| Bimagrumab 30 mg/kg + Semaglutide 1.0 mg | Percentage of Participants With Body Mass Index (BMI) Categories at Baseline and Week 48 | Overweight (Baseline) | 1.8 percentage of participants |
| Bimagrumab 30 mg/kg + Semaglutide 1.0 mg | Percentage of Participants With Body Mass Index (BMI) Categories at Baseline and Week 48 | Healthy weight (Week 48) | 7 percentage of participants |
| Bimagrumab 30 mg/kg + Semaglutide 1.0 mg | Percentage of Participants With Body Mass Index (BMI) Categories at Baseline and Week 48 | Obesity class III (Week 48) | 2.3 percentage of participants |
| Bimagrumab 30 mg/kg + Semaglutide 1.0 mg | Percentage of Participants With Body Mass Index (BMI) Categories at Baseline and Week 48 | Obesity class I (Baseline) | 25.0 percentage of participants |
| Bimagrumab 30 mg/kg + Semaglutide 1.0 mg | Percentage of Participants With Body Mass Index (BMI) Categories at Baseline and Week 48 | Healthy weight (Baseline) | 0 percentage of participants |
| Bimagrumab 30 mg/kg + Semaglutide 1.0 mg | Percentage of Participants With Body Mass Index (BMI) Categories at Baseline and Week 48 | Obesity class II (Baseline) | 50 percentage of participants |
| Bimagrumab 30 mg/kg + Semaglutide 1.0 mg | Percentage of Participants With Body Mass Index (BMI) Categories at Baseline and Week 48 | Obesity class II (Week 48) | 11.6 percentage of participants |
| Bimagrumab 30 mg/kg + Semaglutide 1.0 mg | Percentage of Participants With Body Mass Index (BMI) Categories at Baseline and Week 48 | Obesity class I (Week 48) | 53.5 percentage of participants |
| Bimagrumab 30 mg/kg + Semaglutide 2.4 mg | Percentage of Participants With Body Mass Index (BMI) Categories at Baseline and Week 48 | Obesity class I (Baseline) | 34.5 percentage of participants |
| Bimagrumab 30 mg/kg + Semaglutide 2.4 mg | Percentage of Participants With Body Mass Index (BMI) Categories at Baseline and Week 48 | Obesity class I (Week 48) | 27.9 percentage of participants |
| Bimagrumab 30 mg/kg + Semaglutide 2.4 mg | Percentage of Participants With Body Mass Index (BMI) Categories at Baseline and Week 48 | Obesity class II (Baseline) | 27.3 percentage of participants |
| Bimagrumab 30 mg/kg + Semaglutide 2.4 mg | Percentage of Participants With Body Mass Index (BMI) Categories at Baseline and Week 48 | Healthy weight (Week 48) | 11.6 percentage of participants |
| Bimagrumab 30 mg/kg + Semaglutide 2.4 mg | Percentage of Participants With Body Mass Index (BMI) Categories at Baseline and Week 48 | Obesity class III (Baseline) | 32.7 percentage of participants |
| Bimagrumab 30 mg/kg + Semaglutide 2.4 mg | Percentage of Participants With Body Mass Index (BMI) Categories at Baseline and Week 48 | Obesity class II (Week 48) | 14 percentage of participants |
| Bimagrumab 30 mg/kg + Semaglutide 2.4 mg | Percentage of Participants With Body Mass Index (BMI) Categories at Baseline and Week 48 | Overweight (Baseline) | 5.5 percentage of participants |
| Bimagrumab 30 mg/kg + Semaglutide 2.4 mg | Percentage of Participants With Body Mass Index (BMI) Categories at Baseline and Week 48 | Obesity class III (Week 48) | 9.3 percentage of participants |
| Bimagrumab 30 mg/kg + Semaglutide 2.4 mg | Percentage of Participants With Body Mass Index (BMI) Categories at Baseline and Week 48 | Healthy weight (Baseline) | 0 percentage of participants |
| Bimagrumab 30 mg/kg + Semaglutide 2.4 mg | Percentage of Participants With Body Mass Index (BMI) Categories at Baseline and Week 48 | Overweight (Week 48) | 37.2 percentage of participants |
Secondary
Percentage of Participants With Reduction in Body Weight ≥ 5%, ≥ 10% and ≥15% at Week 48
Body weight was measured in kgs to the nearest 0.1 kg.
Time frame: Week 48
Population: All randomized participants who received at least one dose of the study drug and had evaluable data for this outcome.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With Reduction in Body Weight ≥ 5%, ≥ 10% and ≥15% at Week 48 | Reduction in ≥ 5% Body Weight | 38.8 percentage of participants |
| Placebo | Percentage of Participants With Reduction in Body Weight ≥ 5%, ≥ 10% and ≥15% at Week 48 | Reduction in ≥ 15% Body Weight | 5.3 percentage of participants |
| Placebo | Percentage of Participants With Reduction in Body Weight ≥ 5%, ≥ 10% and ≥15% at Week 48 | Reduction in ≥ 10% Body Weight | 10.4 percentage of participants |
| Bimagrumab 10 mg/kg | Percentage of Participants With Reduction in Body Weight ≥ 5%, ≥ 10% and ≥15% at Week 48 | Reduction in ≥ 15% Body Weight | 11.7 percentage of participants |
| Bimagrumab 10 mg/kg | Percentage of Participants With Reduction in Body Weight ≥ 5%, ≥ 10% and ≥15% at Week 48 | Reduction in ≥ 10% Body Weight | 25.0 percentage of participants |
| Bimagrumab 10 mg/kg | Percentage of Participants With Reduction in Body Weight ≥ 5%, ≥ 10% and ≥15% at Week 48 | Reduction in ≥ 5% Body Weight | 51.8 percentage of participants |
| Bimagrumab 30 mg/kg | Percentage of Participants With Reduction in Body Weight ≥ 5%, ≥ 10% and ≥15% at Week 48 | Reduction in ≥ 10% Body Weight | 39.3 percentage of participants |
| Bimagrumab 30 mg/kg | Percentage of Participants With Reduction in Body Weight ≥ 5%, ≥ 10% and ≥15% at Week 48 | Reduction in ≥ 5% Body Weight | 68.8 percentage of participants |
| Bimagrumab 30 mg/kg | Percentage of Participants With Reduction in Body Weight ≥ 5%, ≥ 10% and ≥15% at Week 48 | Reduction in ≥ 15% Body Weight | 23.3 percentage of participants |
| Placebo + Semaglutide 1.0 mg | Percentage of Participants With Reduction in Body Weight ≥ 5%, ≥ 10% and ≥15% at Week 48 | Reduction in ≥ 15% Body Weight | 30.3 percentage of participants |
| Placebo + Semaglutide 1.0 mg | Percentage of Participants With Reduction in Body Weight ≥ 5%, ≥ 10% and ≥15% at Week 48 | Reduction in ≥ 5% Body Weight | 67.8 percentage of participants |
| Placebo + Semaglutide 1.0 mg | Percentage of Participants With Reduction in Body Weight ≥ 5%, ≥ 10% and ≥15% at Week 48 | Reduction in ≥ 10% Body Weight | 43.4 percentage of participants |
| Placebo + Semaglutide 2.4 mg | Percentage of Participants With Reduction in Body Weight ≥ 5%, ≥ 10% and ≥15% at Week 48 | Reduction in ≥ 10% Body Weight | 74.8 percentage of participants |
| Placebo + Semaglutide 2.4 mg | Percentage of Participants With Reduction in Body Weight ≥ 5%, ≥ 10% and ≥15% at Week 48 | Reduction in ≥ 5% Body Weight | 88.2 percentage of participants |
| Placebo + Semaglutide 2.4 mg | Percentage of Participants With Reduction in Body Weight ≥ 5%, ≥ 10% and ≥15% at Week 48 | Reduction in ≥ 15% Body Weight | 43.4 percentage of participants |
| Bimagrumab 10 mg/kg + Semaglutide 1.0 mg | Percentage of Participants With Reduction in Body Weight ≥ 5%, ≥ 10% and ≥15% at Week 48 | Reduction in ≥ 10% Body Weight | 54.9 percentage of participants |
| Bimagrumab 10 mg/kg + Semaglutide 1.0 mg | Percentage of Participants With Reduction in Body Weight ≥ 5%, ≥ 10% and ≥15% at Week 48 | Reduction in ≥ 5% Body Weight | 82.9 percentage of participants |
| Bimagrumab 10 mg/kg + Semaglutide 1.0 mg | Percentage of Participants With Reduction in Body Weight ≥ 5%, ≥ 10% and ≥15% at Week 48 | Reduction in ≥ 15% Body Weight | 32.2 percentage of participants |
| Bimagrumab 10 mg/kg + Semaglutide 2.4 mg | Percentage of Participants With Reduction in Body Weight ≥ 5%, ≥ 10% and ≥15% at Week 48 | Reduction in ≥ 15% Body Weight | 41.6 percentage of participants |
| Bimagrumab 10 mg/kg + Semaglutide 2.4 mg | Percentage of Participants With Reduction in Body Weight ≥ 5%, ≥ 10% and ≥15% at Week 48 | Reduction in ≥ 5% Body Weight | 84.2 percentage of participants |
| Bimagrumab 10 mg/kg + Semaglutide 2.4 mg | Percentage of Participants With Reduction in Body Weight ≥ 5%, ≥ 10% and ≥15% at Week 48 | Reduction in ≥ 10% Body Weight | 72.1 percentage of participants |
| Bimagrumab 30 mg/kg + Semaglutide 1.0 mg | Percentage of Participants With Reduction in Body Weight ≥ 5%, ≥ 10% and ≥15% at Week 48 | Reduction in ≥ 10% Body Weight | 66.2 percentage of participants |
| Bimagrumab 30 mg/kg + Semaglutide 1.0 mg | Percentage of Participants With Reduction in Body Weight ≥ 5%, ≥ 10% and ≥15% at Week 48 | Reduction in ≥ 15% Body Weight | 47.7 percentage of participants |
| Bimagrumab 30 mg/kg + Semaglutide 1.0 mg | Percentage of Participants With Reduction in Body Weight ≥ 5%, ≥ 10% and ≥15% at Week 48 | Reduction in ≥ 5% Body Weight | 83.9 percentage of participants |
| Bimagrumab 30 mg/kg + Semaglutide 2.4 mg | Percentage of Participants With Reduction in Body Weight ≥ 5%, ≥ 10% and ≥15% at Week 48 | Reduction in ≥ 10% Body Weight | 79.2 percentage of participants |
| Bimagrumab 30 mg/kg + Semaglutide 2.4 mg | Percentage of Participants With Reduction in Body Weight ≥ 5%, ≥ 10% and ≥15% at Week 48 | Reduction in ≥ 15% Body Weight | 63.9 percentage of participants |
| Bimagrumab 30 mg/kg + Semaglutide 2.4 mg | Percentage of Participants With Reduction in Body Weight ≥ 5%, ≥ 10% and ≥15% at Week 48 | Reduction in ≥ 5% Body Weight | 86.1 percentage of participants |
Secondary
Percentage of Participants With Reduction in Fat Mass ≥ 10% With <5% Decrease (or an Increase) in Lean Mass by DXA at Week 48
DXA was used to assess changes in body composition.
Time frame: Week 48
Population: All randomized participants who received at least one dose of the study drug and had evaluable data for this outcome.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With Reduction in Fat Mass ≥ 10% With <5% Decrease (or an Increase) in Lean Mass by DXA at Week 48 | 18.1 percentage of participants |
| Bimagrumab 10 mg/kg | Percentage of Participants With Reduction in Fat Mass ≥ 10% With <5% Decrease (or an Increase) in Lean Mass by DXA at Week 48 | 55.9 percentage of participants |
| Bimagrumab 30 mg/kg | Percentage of Participants With Reduction in Fat Mass ≥ 10% With <5% Decrease (or an Increase) in Lean Mass by DXA at Week 48 | 58.3 percentage of participants |
| Placebo + Semaglutide 1.0 mg | Percentage of Participants With Reduction in Fat Mass ≥ 10% With <5% Decrease (or an Increase) in Lean Mass by DXA at Week 48 | 26.3 percentage of participants |
| Placebo + Semaglutide 2.4 mg | Percentage of Participants With Reduction in Fat Mass ≥ 10% With <5% Decrease (or an Increase) in Lean Mass by DXA at Week 48 | 20.4 percentage of participants |
| Bimagrumab 10 mg/kg + Semaglutide 1.0 mg | Percentage of Participants With Reduction in Fat Mass ≥ 10% With <5% Decrease (or an Increase) in Lean Mass by DXA at Week 48 | 52.6 percentage of participants |
| Bimagrumab 10 mg/kg + Semaglutide 2.4 mg | Percentage of Participants With Reduction in Fat Mass ≥ 10% With <5% Decrease (or an Increase) in Lean Mass by DXA at Week 48 | 52.9 percentage of participants |
| Bimagrumab 30 mg/kg + Semaglutide 1.0 mg | Percentage of Participants With Reduction in Fat Mass ≥ 10% With <5% Decrease (or an Increase) in Lean Mass by DXA at Week 48 | 63.7 percentage of participants |
| Bimagrumab 30 mg/kg + Semaglutide 2.4 mg | Percentage of Participants With Reduction in Fat Mass ≥ 10% With <5% Decrease (or an Increase) in Lean Mass by DXA at Week 48 | 58.9 percentage of participants |
Secondary
Percentage of Participants With Reduction in Fat Mass ≥ 5% ≥ 10% ≥ 15% by DXA at Week 48
DXA was used to assess the changes in body composition.
Time frame: Week 48
Population: All randomized participants who received at least one dose of the study drug and had evaluable data for this outcome.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With Reduction in Fat Mass ≥ 5% ≥ 10% ≥ 15% by DXA at Week 48 | ≥ 5% reduction in Fat Mass | 45.3 percentage of participants |
| Placebo | Percentage of Participants With Reduction in Fat Mass ≥ 5% ≥ 10% ≥ 15% by DXA at Week 48 | ≥ 15% reduction in Fat Mass | 12.7 percentage of participants |
| Placebo | Percentage of Participants With Reduction in Fat Mass ≥ 5% ≥ 10% ≥ 15% by DXA at Week 48 | ≥ 10% reduction in Fat Mass | 25.9 percentage of participants |
| Bimagrumab 10 mg/kg | Percentage of Participants With Reduction in Fat Mass ≥ 5% ≥ 10% ≥ 15% by DXA at Week 48 | ≥ 15% reduction in Fat Mass | 39.4 percentage of participants |
| Bimagrumab 10 mg/kg | Percentage of Participants With Reduction in Fat Mass ≥ 5% ≥ 10% ≥ 15% by DXA at Week 48 | ≥ 10% reduction in Fat Mass | 65.1 percentage of participants |
| Bimagrumab 10 mg/kg | Percentage of Participants With Reduction in Fat Mass ≥ 5% ≥ 10% ≥ 15% by DXA at Week 48 | ≥ 5% reduction in Fat Mass | 74.4 percentage of participants |
| Bimagrumab 30 mg/kg | Percentage of Participants With Reduction in Fat Mass ≥ 5% ≥ 10% ≥ 15% by DXA at Week 48 | ≥ 10% reduction in Fat Mass | 68.3 percentage of participants |
| Bimagrumab 30 mg/kg | Percentage of Participants With Reduction in Fat Mass ≥ 5% ≥ 10% ≥ 15% by DXA at Week 48 | ≥ 5% reduction in Fat Mass | 79.3 percentage of participants |
| Bimagrumab 30 mg/kg | Percentage of Participants With Reduction in Fat Mass ≥ 5% ≥ 10% ≥ 15% by DXA at Week 48 | ≥ 15% reduction in Fat Mass | 54.8 percentage of participants |
| Placebo + Semaglutide 1.0 mg | Percentage of Participants With Reduction in Fat Mass ≥ 5% ≥ 10% ≥ 15% by DXA at Week 48 | ≥ 15% reduction in Fat Mass | 47.8 percentage of participants |
| Placebo + Semaglutide 1.0 mg | Percentage of Participants With Reduction in Fat Mass ≥ 5% ≥ 10% ≥ 15% by DXA at Week 48 | ≥ 5% reduction in Fat Mass | 75.7 percentage of participants |
| Placebo + Semaglutide 1.0 mg | Percentage of Participants With Reduction in Fat Mass ≥ 5% ≥ 10% ≥ 15% by DXA at Week 48 | ≥ 10% reduction in Fat Mass | 59.5 percentage of participants |
| Placebo + Semaglutide 2.4 mg | Percentage of Participants With Reduction in Fat Mass ≥ 5% ≥ 10% ≥ 15% by DXA at Week 48 | ≥ 10% reduction in Fat Mass | 83.2 percentage of participants |
| Placebo + Semaglutide 2.4 mg | Percentage of Participants With Reduction in Fat Mass ≥ 5% ≥ 10% ≥ 15% by DXA at Week 48 | ≥ 5% reduction in Fat Mass | 90.6 percentage of participants |
| Placebo + Semaglutide 2.4 mg | Percentage of Participants With Reduction in Fat Mass ≥ 5% ≥ 10% ≥ 15% by DXA at Week 48 | ≥ 15% reduction in Fat Mass | 76.1 percentage of participants |
| Bimagrumab 10 mg/kg + Semaglutide 1.0 mg | Percentage of Participants With Reduction in Fat Mass ≥ 5% ≥ 10% ≥ 15% by DXA at Week 48 | ≥ 10% reduction in Fat Mass | 82.7 percentage of participants |
| Bimagrumab 10 mg/kg + Semaglutide 1.0 mg | Percentage of Participants With Reduction in Fat Mass ≥ 5% ≥ 10% ≥ 15% by DXA at Week 48 | ≥ 5% reduction in Fat Mass | 88.5 percentage of participants |
| Bimagrumab 10 mg/kg + Semaglutide 1.0 mg | Percentage of Participants With Reduction in Fat Mass ≥ 5% ≥ 10% ≥ 15% by DXA at Week 48 | ≥ 15% reduction in Fat Mass | 75.7 percentage of participants |
| Bimagrumab 10 mg/kg + Semaglutide 2.4 mg | Percentage of Participants With Reduction in Fat Mass ≥ 5% ≥ 10% ≥ 15% by DXA at Week 48 | ≥ 15% reduction in Fat Mass | 75.9 percentage of participants |
| Bimagrumab 10 mg/kg + Semaglutide 2.4 mg | Percentage of Participants With Reduction in Fat Mass ≥ 5% ≥ 10% ≥ 15% by DXA at Week 48 | ≥ 5% reduction in Fat Mass | 86.4 percentage of participants |
| Bimagrumab 10 mg/kg + Semaglutide 2.4 mg | Percentage of Participants With Reduction in Fat Mass ≥ 5% ≥ 10% ≥ 15% by DXA at Week 48 | ≥ 10% reduction in Fat Mass | 79.5 percentage of participants |
| Bimagrumab 30 mg/kg + Semaglutide 1.0 mg | Percentage of Participants With Reduction in Fat Mass ≥ 5% ≥ 10% ≥ 15% by DXA at Week 48 | ≥ 10% reduction in Fat Mass | 82.1 percentage of participants |
| Bimagrumab 30 mg/kg + Semaglutide 1.0 mg | Percentage of Participants With Reduction in Fat Mass ≥ 5% ≥ 10% ≥ 15% by DXA at Week 48 | ≥ 15% reduction in Fat Mass | 73.5 percentage of participants |
| Bimagrumab 30 mg/kg + Semaglutide 1.0 mg | Percentage of Participants With Reduction in Fat Mass ≥ 5% ≥ 10% ≥ 15% by DXA at Week 48 | ≥ 5% reduction in Fat Mass | 87.9 percentage of participants |
| Bimagrumab 30 mg/kg + Semaglutide 2.4 mg | Percentage of Participants With Reduction in Fat Mass ≥ 5% ≥ 10% ≥ 15% by DXA at Week 48 | ≥ 10% reduction in Fat Mass | 87.1 percentage of participants |
| Bimagrumab 30 mg/kg + Semaglutide 2.4 mg | Percentage of Participants With Reduction in Fat Mass ≥ 5% ≥ 10% ≥ 15% by DXA at Week 48 | ≥ 15% reduction in Fat Mass | 84.1 percentage of participants |
| Bimagrumab 30 mg/kg + Semaglutide 2.4 mg | Percentage of Participants With Reduction in Fat Mass ≥ 5% ≥ 10% ≥ 15% by DXA at Week 48 | ≥ 5% reduction in Fat Mass | 90.0 percentage of participants |
Secondary
Percentage of Participants With Reduction in Waist Circumference ≥ 5 cm at Week 48
Waist circumference was measured in a standing position with a non-stretchable measuring tape to the nearest 0.1 cm.
Time frame: Week 48
Population: All randomized participants who received at least one dose of the study drug and had evaluable data for this outcome.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With Reduction in Waist Circumference ≥ 5 cm at Week 48 | 47.1 percentage of participants |
| Bimagrumab 10 mg/kg | Percentage of Participants With Reduction in Waist Circumference ≥ 5 cm at Week 48 | 60.5 percentage of participants |
| Bimagrumab 30 mg/kg | Percentage of Participants With Reduction in Waist Circumference ≥ 5 cm at Week 48 | 67.6 percentage of participants |
| Placebo + Semaglutide 1.0 mg | Percentage of Participants With Reduction in Waist Circumference ≥ 5 cm at Week 48 | 62.6 percentage of participants |
| Placebo + Semaglutide 2.4 mg | Percentage of Participants With Reduction in Waist Circumference ≥ 5 cm at Week 48 | 79.3 percentage of participants |
| Bimagrumab 10 mg/kg + Semaglutide 1.0 mg | Percentage of Participants With Reduction in Waist Circumference ≥ 5 cm at Week 48 | 81.9 percentage of participants |
| Bimagrumab 10 mg/kg + Semaglutide 2.4 mg | Percentage of Participants With Reduction in Waist Circumference ≥ 5 cm at Week 48 | 84.5 percentage of participants |
| Bimagrumab 30 mg/kg + Semaglutide 1.0 mg | Percentage of Participants With Reduction in Waist Circumference ≥ 5 cm at Week 48 | 81.6 percentage of participants |
| Bimagrumab 30 mg/kg + Semaglutide 2.4 mg | Percentage of Participants With Reduction in Waist Circumference ≥ 5 cm at Week 48 | 86.5 percentage of participants |