ObesityPhase 2NCT05616013
Safety and Efficacy of Bimagrumab and Semaglutide in Adults Who Are Overweight or Obese
A Phase 2 study testing Bimagrumab and Semaglutide in people with Obesity and Obese, run by Eli Lilly and Company at 26 sites in 3 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Obesity, Obese, Overweight or Obesity
- What is being tested?
- Bimagrumab and Semaglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 507 participants
- Where
- 26 sitesin 3 countries
- Study dates
- 16 Nov 2022to 14 Jun 2025
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
26 sites in 3 countries.
26 sites in 3 countries
United States10 sites
Pinnacle Research Group, LLC
Anniston, Alabama, 36207
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
SPICA Clinical
Columbia, South Carolina, 29322
Cullman Clinical Trials
Cullman, Alabama, 35055
Indago Research & Health Center, Inc
Hialeah, Florida, 33012
Clinical Neuroscience Solutions Inc
Jacksonville, Florida, 32256
Altus Research
Lake Worth, Florida, 33461
Monroe Biomedical Research
Monroe, North Carolina, 28112
Weill Cornell Medical College
New York, New York, 10021
Mt. Olympus Medical Research
Sugar Land, Texas, 77479
Australia8 sites
Northern Beaches Clinical Research
Brookvale, New South Wales, 2100
Emeritus Research
Camberwell, 3124
Austin Health
Heidelberg Heights, Victoria, 3081
University of The Sunshine Coast Morayfield
Morayfield, Queensland, 4506
Royal North Shore Hospital
Saint Leonards, New South Wales, 2065
University of the Sunshine Coast Clinical Trial Centre
Sippy Downs, Queensland, 04556
University of The Sunshine Coast South Brisbane
South Brisbane, Queensland, 4101
Gold Coast University Hospital
Southport, Queensland, 4215
New Zealand8 sites
New Zealand Clinical Research Auckland
Auckland, 1010
Optimal Clinical Trials
Auckland, 1010
Middlemore Hospital
Auckland, 2025
Southern Clinical Trials Ltd
Beckenham, Christchurch, Canterbury, 8013
New Zealand Clinical Research Christchurch
Christchurch, 8011
Lakeland Clinical Trials Waikato
Hamilton, 3200
Southern Clinical Trials Tasman
Nelson, 7011
P3 Research
Newtown, Wellington Region, 6242
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Multi-Center Study of Intravenous Bimagrumab, Alone or in Addition to Open Label Subcutaneous Semaglutide, to Investigate the Efficacy and Safety in Overweight or Obese Men and Women
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
Read the 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.
- Conditions
- Obesity, Obese, Overweight or Obesity
- Being tested
- Bimagrumab, Semaglutide, Placebo
- Keywords
- bimagrumab, semaglutide
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BimagrumabBiological
Human monoclonal antibody to the activin receptor type II
SemaglutideDrug
Also called Wegovy, Ozempic
Glucagon-like peptide-1 (GLP-1) receptor agonist
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo/30 mg/kg Bimagrumab | Placebo comparator | Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, and 40, followed by intravenous 30 milligrams per kilogram (mg/kg) bimagrumab at Weeks 52 and 64. Receives: Other: Placebo |
| 10/30 mg/kg Bimagrumab | Experimental | Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, and 40, followed by intravenous 30 mg/kg bimagrumab at Weeks 52 and 64. Receives: Biological: Bimagrumab |
| 30 mg/kg Bimagrumab | Experimental | Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64. Receives: Biological: Bimagrumab |
| Placebo + 1.0 mg Semaglutide | Experimental | Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, 40 and subcutaneous 1.0 milligram (mg) semaglutide weekly as per the below dose escalation schedule:
* Weeks 1 to 4: 0.25 mg
* Weeks 5 to 8: 0.5 mg
* Weeks 9 to 71: 1.0 mg Receives: Drug: Semaglutide; Other: Placebo |
| Placebo + 2.4 mg Semaglutide | Experimental | Participants received intravenous placebo at baseline and at Weeks 4, 16, 28, 40 and subcutaneous 2.4 mg semaglutide weekly 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 71: 2.4 mg Receives: Drug: Semaglutide; Other: Placebo |
| 10 mg/kg Bimagrumab + 1.0 mg Semaglutide | Experimental | Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 1.0 mg semaglutide weekly as per the below dose escalation schedule:
* Weeks 1 to 4: 0.25 mg
* Weeks 5 to 8: 0.5 mg
* Weeks 9 to 71: 1.0 mg Receives: Biological: Bimagrumab; Drug: Semaglutide |
| 10 mg/kg Bimagrumab + 2.4 mg Semaglutide | Experimental | Participants received intravenous 10 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 2.4 mg semaglutide weekly 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 71: 2.4 mg Receives: Biological: Bimagrumab; Drug: Semaglutide |
| 30 mg/kg Bimagrumab + 1.0 mg Semaglutide | Experimental | Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 1.0 mg semaglutide weekly as per the below dose escalation schedule:
* Weeks 1 to 4: 0.25 mg
* Weeks 5 to 8: 0.5 mg
* Weeks 9 to 71: 1.0 mg Receives: Biological: Bimagrumab; Drug: Semaglutide |
| 30 mg/kg Bimagrumab + 2.4 mg Semaglutide | Experimental | Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64, and subcutaneous 2.4 mg semaglutide weekly 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 71: 2.4 mg Receives: Biological: Bimagrumab; Drug: Semaglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Body Weight at 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.
Measured: Baseline, Week 48
Secondary outcomes (41)
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). 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.
Measured: Baseline, Week 48
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. 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.
Measured: Baseline, Week 72
Change From Baseline in Total Body Fat Mass in Kilograms (kg) at 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.
Measured: Baseline, Week 48
Change From Baseline in Total Body Fat Mass in kg at 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.
Measured: Baseline, Week 72
Percent Change From Baseline for Fat Mass by DXA at 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.
Measured: Baseline, Week 48
Percent Change From Baseline for Fat Mass by DXA at 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.
Measured: Baseline, Week 72
Change From Baseline in Visceral Adipose Tissue (VAT), Subcutaneous Adipose Tissue (SAT) and Trunk Fat Mass by DXA at 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.
Measured: Baseline, Week 48
Change From Baseline in VAT, SAT and Trunk Fat Mass by DXA at 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.
Measured: Baseline, Week 72
Percentage of Participants With Reduction in Waist Circumference Greater Than or Equal to (≥) 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. Only participants with non-missing baseline value were included in analysis.
Measured: Week 48
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. Only participants with non-missing baseline value were included in analysis.
Measured: Week 48
Percentage of Participants With Reduction in Fat Mass ≥ 5% ≥ 10% ≥ 15% by DXA at Week 48
Only participants with non-missing baseline value were included in analysis.
Measured: Week 48
Percentage of Participants Achieving Fat Mass ≥ 10% Reduction With <5% Decrease in Lean Mass by DXA at Week 48
Only participants with non-missing baseline value were included in analysis.
Measured: Week 48
Percentage of Participants Achieving >5 kg Weight Loss and Fat Loss Index (FLI) of >70%, >80%, and >90% by DXA at 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.
Measured: Week 48
Change From Baseline in Body Fat Mass by Bioelectrical Impedance Analysis (BIA) at 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.
Measured: Baseline, Week 48
Change From Baseline in Body Fat Mass by BIA at 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.
Measured: Baseline, Week 72
Percent Change From Baseline in Body Fat by BIA at 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.
Measured: Baseline, Week 48
Percent Change From Baseline in Body Fat by BIA at 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.
Measured: Baseline, Week 72
Change From Baseline in Lean Mass by DXA at 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.
Measured: Baseline, Week 48
Change From Baseline in Lean Mass by DXA at 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.
Measured: Baseline, Week 72
Percent Change From Baseline in Lean Body Mass by DXA at 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.
Measured: Baseline, Week 48
Percent Change From Baseline in Lean Body Mass by DXA at 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.
Measured: Baseline, Week 72
Percent Change From Baseline in Appendicular Lean Mass by DXA at 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.
Measured: Baseline, Week 48
Percent Change From Baseline in Appendicular Lean Mass by DXA at 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.
Measured: Baseline, Week 72
Change From Baseline in Lean Mass (kg) by BIA at 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.
Measured: Baseline, Week 48
Change From Baseline in Lean Mass (kg) by BIA at 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.
Measured: Baseline, Week 72
Percent Change From Baseline in Lean Body Mass by BIA at 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.
Measured: Baseline, Week 48
Percent Change From Baseline in Lean Body Mass by BIA at 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.
Measured: Baseline, Week 72
Percentage of Participants With Body Mass Index (BMI) Categories at Baseline and Week 48
BMI categories:
- 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
Measured: Baseline, Week 48
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
Measured: Baseline up to 48 weeks
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
Measured: Baseline up to 48 weeks
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
Measured: Baseline up to 48 weeks
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. 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.
Measured: Baseline, 48 weeks
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.
Measured: Baseline, Week 24
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 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.
Measured: Baseline, Week 24
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
Measured: Baseline, Week 48
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.
Measured: Baseline, Week 48
Change From Baseline in Quality of Life SF-36v2 Acute Form Physical Functioning Domain Score 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
Measured: Baseline, Week 72
Change From Baseline in Quality of Life SF-36v2 Acute Form Total Score at 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.
Measured: Baseline, Week 72
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.'
Measured: Baseline, Week 24
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.'
Measured: Baseline, Week 48
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.'
Measured: Baseline, Week 72
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start16 Nov 2022
- Primary completion16 May 2024
- Study completion14 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 507 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Versanis Bio, Inc.
- Responsible party
- Sponsor
- Investigators
- Call 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05616013
- Sponsor's protocol ID
- 18828
- Other IDs
- J4Z-MC-GIDA, VER201-PH2-031
- Status last verified
- Jun 2026
- First submitted
- 16 Oct 2022
- Last updated
- 8 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Publications
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.
PubMed 41772149Moon 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.
PubMed 40230053