BIOLOGICAL
Bimagrumab
Human monoclonal antibody to the activin receptor type II
Safety and Efficacy of Bimagrumab and Semaglutide in Adults Who Are Overweight or Obese
Status
Completed
Phase
Phase 2
Enrollment
507
Locations
26
Results
Posted
Publications
2
Study summary
What the protocol is testing.
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
Full 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
Treatment arms and agents.
DRUG
Semaglutide
Glucagon-like peptide-1 (GLP-1) receptor agonist
OTHER
Placebo
Placebo
Timeline
From registration to results.
First posted
Nov 14, 2022
Study start
Nov 16, 2022
Primary completion
May 16, 2024
Study completion
Jun 14, 2025
Results posted
Jul 18, 2025
Registry updated
Jul 8, 2026
Outcomes
What the study measures.
Primary outcomes
Change From Baseline in Body Weight at Week 48
Time frame · 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 outcomes
Change From Baseline in Waist Circumference at Week 48
Time frame · 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
Time frame · 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
Time frame · 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
Time frame · 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
Time frame · 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
Time frame · 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
Time frame · 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
Time frame · 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
Time frame · 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
Time frame · 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.
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 80 Years
- Sex
- ALL
- Healthy volunteers
- No
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 exclusion criteria, which in the Investigator's opinion, might jeopardize the participant's safety or compliance with the protocol
Study locations
26 registered sites.
Australia · New Zealand · United States. Showing up to 24 locations stored in the fast local snapshot.
Pinnacle Research Group, LLC
Anniston, Alabama, United States
Cullman Clinical Trials
Cullman, Alabama, United States
Indago Research & Health Center, Inc
Hialeah, Florida, United States
Clinical Neuroscience Solutions Inc
Jacksonville, Florida, United States
Altus Research
Lake Worth, Florida, United States
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States
Weill Cornell Medical College
New York, New York, United States
Monroe Biomedical Research
Monroe, North Carolina, United States
SPICA Clinical
Columbia, South Carolina, United States
Mt. Olympus Medical Research
Sugar Land, Texas, United States
Northern Beaches Clinical Research
Brookvale, New South Wales, Australia
Royal North Shore Hospital
Saint Leonards, New South Wales, Australia
University of The Sunshine Coast Morayfield
Morayfield, Queensland, Australia
University of the Sunshine Coast Clinical Trial Centre
Sippy Downs, Queensland, Australia
University of The Sunshine Coast South Brisbane
South Brisbane, Queensland, Australia
Gold Coast University Hospital
Southport, Queensland, Australia
Austin Health
Heidelberg Heights, Victoria, Australia
Emeritus Research
Camberwell, Australia
Southern Clinical Trials Ltd
Beckenham, Christchurch, Canterbury, New Zealand
P3 Research
Newtown, Wellington Region, New Zealand
New Zealand Clinical Research Auckland
Auckland, New Zealand
Optimal Clinical Trials
Auckland, New Zealand
Middlemore Hospital
Auckland, New Zealand
New Zealand Clinical Research Christchurch
Christchurch, New Zealand
Publications
Results and literature.
PMID 41772149 ↗Heymsfield SB, Aronne LJ, Montgomery P, Klickstein LB, Coleman LA, Dole K, Mindeholm L, Spruill S, Li X, Attie KM; BELIEVE trial investigators. Bimagrumab plus semaglutide alone or in combination for the treatment of obesity: a randomized phase 2 trial. Nat Med. 2026 Mar;32(3):869-882. doi: 10.1038/s41591-026-04204-0. Epub 2026 Mar 2.PMID 40230053 ↗Moon S, Choi JW, Park JH, Kim DS, Ahn Y, Kim Y, Kong SH, Oh CM. Association of Appendicular Skeletal Muscle Mass Index and Insulin Resistance With Mortality in Multi-Nationwide Cohorts. J Cachexia Sarcopenia Muscle. 2025 Apr;16(2):e13811. doi: 10.1002/jcsm.13811.
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