Safety and Efficacy of Bimagrumab and Semaglutide in Adults Who Are Overweight or Obese

NCT05616013
clinicaltrials.gov
Phase
Phase 2
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Recruitment status
Completed
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Participants
507
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Lead sponsor
Eli Lilly and Company
clinicaltrials.gov
Start date
2022-11-16
clinicaltrials.gov
Number of sites
26
clinicaltrials.gov

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
clinicaltrials.gov
Short title
Safety and Efficacy of Bimagrumab and Semaglutide in Adults Who Are Overweight or Obese
clinicaltrials.gov
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
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Control arm
Placebo
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Registry reports results
Yes
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Listing at source
Listed
clinicaltrials.gov
Recruitment status
Completed
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Phase
Phase 2
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Study type
Interventional
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Completion date
2025-06-14
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First posted
2022-11-14
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Registry last updated
2026-07-08
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Primary completion date
2024-05-16
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Start date
2022-11-16
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Actual participants
507
clinicaltrials.gov
Participants
507
clinicaltrials.gov
Participant count basis
Actual
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Protocol amendments
7
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Number of sites
26
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Eli Lilly and Company
clinicaltrials.gov
Source registry
ClinicalTrials.gov
clinicaltrials.gov

Registry ID
NCT05616013
clinicaltrials.gov
ClinicalTrials.gov ID
NCT05616013
clinicaltrials.gov
Registry record
Open registry record
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Allocation
Randomised
Model
Factorial
Purpose
Treatment
Masking
Double masking
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.
Masked roles
Participants, Investigators
Sources for study design
clinicaltrials.gov

  1. Change From Baseline in Body Weight at Week 48

    Timeframe: 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.

  1. Change From Baseline in Waist Circumference at Week 48

    Timeframe: 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.

  2. Change From Baseline in Waist Circumference at Week 72

    Timeframe: 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.

  3. Change From Baseline in Total Body Fat Mass in Kilograms (kg) at Week 48

    Timeframe: 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.

  4. Change From Baseline in Total Body Fat Mass in kg at Week 72

    Timeframe: 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.

  5. Percent Change From Baseline for Fat Mass by DXA at Week 48

    Timeframe: 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.

  6. Percent Change From Baseline for Fat Mass by DXA at Week 72

    Timeframe: 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.

  7. Change From Baseline in Visceral Adipose Tissue (VAT), Subcutaneous Adipose Tissue (SAT) and Trunk Fat Mass by DXA at Week 48

    Timeframe: 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.

  8. Change From Baseline in VAT, SAT and Trunk Fat Mass by DXA at Week 72

    Timeframe: 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.

  9. Percentage of Participants With Reduction in Waist Circumference Greater Than or Equal to (≥) 5 cm at Week 48

    Timeframe: 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.

  10. Percentage of Participants With Reduction in Body Weight ≥ 5%, ≥ 10% and ≥15% at Week 48

    Timeframe: 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.

  11. Percentage of Participants With Reduction in Fat Mass ≥ 5% ≥ 10% ≥ 15% by DXA at Week 48

    Timeframe: Week 48

    Only participants with non-missing baseline value were included in analysis.

  12. Percentage of Participants Achieving Fat Mass ≥ 10% Reduction With <5% Decrease in Lean Mass by DXA at Week 48

    Timeframe: Week 48

    Only participants with non-missing baseline value were included in analysis.

  13. Percentage of Participants Achieving >5 kg Weight Loss and Fat Loss Index (FLI) of >70%, >80%, and >90% by DXA at Week 48

    Timeframe: 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.

  14. Change From Baseline in Body Fat Mass by Bioelectrical Impedance Analysis (BIA) at Week 48

    Timeframe: 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.

  15. Change From Baseline in Body Fat Mass by BIA at Week 72

    Timeframe: 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.

  16. Percent Change From Baseline in Body Fat by BIA at Week 48

    Timeframe: 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.

  17. Percent Change From Baseline in Body Fat by BIA at Week 72

    Timeframe: 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.

  18. Change From Baseline in Lean Mass by DXA at Week 48

    Timeframe: 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.

  19. Change From Baseline in Lean Mass by DXA at Week 72

    Timeframe: 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.

  20. Percent Change From Baseline in Lean Body Mass by DXA at Week 48

    Timeframe: 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.

  21. Percent Change From Baseline in Lean Body Mass by DXA at Week 72

    Timeframe: 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.

  22. Percent Change From Baseline in Appendicular Lean Mass by DXA at Week 48

    Timeframe: 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.

  23. Percent Change From Baseline in Appendicular Lean Mass by DXA at Week 72

    Timeframe: 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.

  24. Change From Baseline in Lean Mass (kg) by BIA at Week 48

    Timeframe: 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.

  25. Change From Baseline in Lean Mass (kg) by BIA at Week 72

    Timeframe: 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.

And 16 more, listed on the interactive page.

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
80 Years
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
Sources for eligibility
clinicaltrials.gov

  • Pinnacle Research Group, LLCAnniston, United States
  • Cullman Clinical TrialsCullman, United States
  • Indago Research & Health Center, IncHialeah, United States
  • Clinical Neuroscience Solutions IncJacksonville, United States
  • Altus ResearchLake Worth, United States
  • Pennington Biomedical Research CenterBaton Rouge, United States
  • Weill Cornell Medical CollegeNew York, United States
  • Monroe Biomedical ResearchMonroe, United States
  • SPICA ClinicalColumbia, United States
  • Mt. Olympus Medical ResearchSugar Land, United States
  • Northern Beaches Clinical ResearchBrookvale, Australia
  • Royal North Shore HospitalSaint Leonards, Australia
  • University of The Sunshine Coast MorayfieldMorayfield, Australia
  • University of the Sunshine Coast Clinical Trial CentreSippy Downs, Australia
  • University of The Sunshine Coast South BrisbaneSouth Brisbane, Australia
  • Gold Coast University HospitalSouthport, Australia
  • Austin HealthHeidelberg Heights, Australia
  • Emeritus ResearchCamberwell, Australia
  • Southern Clinical Trials LtdBeckenham, Christchurch, New Zealand
  • P3 ResearchNewtown, New Zealand
  • New Zealand Clinical Research AucklandAuckland, New Zealand
  • Optimal Clinical TrialsAuckland, New Zealand
  • Middlemore HospitalAuckland, New Zealand
  • New Zealand Clinical Research ChristchurchChristchurch, New Zealand
  • Lakeland Clinical Trials WaikatoHamilton, New Zealand

And 1 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • VER201-PH2-031
  • J4Z-MC-GIDA
Sources for references
clinicaltrials.gov

Related records

Drugs (2)

Collaborators (1)

Lead sponsors (1)

Conditions (1)

Targets (2)