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Trial · Interventional

CompletedPhase 2Results postedRegistry data

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

NCTNCT05616013 (opens ClinicalTrials.gov in a new tab)Other id18828Other idJ4Z-MC-GIDAOther idVER201-PH2-031
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
507 participants (actual)
Sponsor
Eli Lilly and Company · Industry
Design
Randomized · Double masking
Countries
3 countries

United States, Australia, New Zealand

Start
16 Nov 2022
Primary completion
16 May 2024
Completion
14 Jun 2025
First posted
14 Nov 2022
Last update posted
8 Jul 2026
Conditions
Obesity · Obese · Overweight or Obesity

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20222023202420252026
  1. Ph 2

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

    NCT05616013

    16 Nov 2022 to 14 Jun 2025

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • BimagrumabBiological
  • SemaglutideDrug
  • PlaceboOther

Arms9

  • Placebo comparator

    Placebo/30 mg/kg Bimagrumab

    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.

  • Experimental

    10/30 mg/kg Bimagrumab

    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.

  • Experimental

    30 mg/kg Bimagrumab

    Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64.

  • Experimental

    Placebo + 1.0 mg Semaglutide

    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

  • Experimental

    Placebo + 2.4 mg Semaglutide

    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

  • Experimental

    10 mg/kg Bimagrumab + 1.0 mg Semaglutide

    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

  • Experimental

    10 mg/kg Bimagrumab + 2.4 mg Semaglutide

    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

  • Experimental

    30 mg/kg Bimagrumab + 1.0 mg Semaglutide

    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

  • Experimental

    30 mg/kg Bimagrumab + 2.4 mg Semaglutide

    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

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change From Baseline in Body Weight at Week 48

    Time frame · Baseline, Week 48

    Registry description

    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(20)

  1. Change From Baseline in Waist Circumference at Week 48

    Time frame · Baseline, Week 48

    Registry description

    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

    Time frame · Baseline, Week 72

    Registry description

    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

    Time frame · Baseline, Week 48

    Registry description

    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

    Time frame · Baseline, Week 72

    Registry description

    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

    Time frame · Baseline, Week 48

    Registry description

    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

    Time frame · Baseline, Week 72

    Registry description

    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

    Time frame · Baseline, Week 48

    Registry description

    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

    Time frame · Baseline, Week 72

    Registry description

    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

    Time frame · Week 48

    Registry description

    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

    Time frame · Week 48

    Registry description

    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

    Time frame · Week 48

    Registry description

    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

    Time frame · Week 48

    Registry description

    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

    Time frame · Week 48

    Registry description

    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

    Time frame · Baseline, Week 48

    Registry description

    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

    Time frame · Baseline, Week 72

    Registry description

    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

    Time frame · Baseline, Week 48

    Registry description

    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

    Time frame · Baseline, Week 72

    Registry description

    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

    Time frame · Baseline, Week 48

    Registry description

    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

    Time frame · Baseline, Week 72

    Registry description

    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

    Time frame · Baseline, Week 48

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeLeast squares mean· Baseline, Week 48

Change From Baseline in Body Weight at Week 48

GroupValue (kilogram (kg))Spread
Placebo/30 mg/kg Bimagrumab-3.311.39
10/30 mg/kg Bimagrumab-5.991.42
30 mg/kg Bimagrumab-9.251.33
Placebo + 1.0 mg Semaglutide-9.761.25
Placebo + 2.4 mg Semaglutide-14.241.17
10 mg/kg Bimagrumab + 1.0 mg Semaglutide-12.731.29
10 mg/kg Bimagrumab + 2.4 mg Semaglutide-14.311.34
30 mg/kg Bimagrumab + 1.0 mg Semaglutide-13.861.29
30 mg/kg Bimagrumab + 2.4 mg Semaglutide-17.791.29
Secondary and other outcome results(7)
Secondary outcomeLeast squares mean· Baseline, Week 48

Change From Baseline in Waist Circumference at Week 48

GroupValue (centimeter (cm))Spread
Placebo/30 mg/kg Bimagrumab-4.711.27
10/30 mg/kg Bimagrumab-7.881.28
30 mg/kg Bimagrumab-10.641.16
Placebo + 1.0 mg Semaglutide-10.571.22
Placebo + 2.4 mg Semaglutide-13.601.11
10 mg/kg Bimagrumab + 1.0 mg Semaglutide-14.630.90
10 mg/kg Bimagrumab + 2.4 mg Semaglutide-16.551.00
30 mg/kg Bimagrumab + 1.0 mg Semaglutide-15.841.10
30 mg/kg Bimagrumab + 2.4 mg Semaglutide-19.031.09
Secondary outcomeLeast squares mean· Baseline, Week 72

Change From Baseline in Waist Circumference at Week 72

GroupValue (centimeter (cm))Spread
Placebo/30 mg/kg Bimagrumab-7.891.32
10/30 mg/kg Bimagrumab-9.591.51
30 mg/kg Bimagrumab-13.041.30
Placebo + 1.0 mg Semaglutide-10.401.41
Placebo + 2.4 mg Semaglutide-14.671.33
10 mg/kg Bimagrumab + 1.0 mg Semaglutide-15.591.07
10 mg/kg Bimagrumab + 2.4 mg Semaglutide-18.101.24
30 mg/kg Bimagrumab + 1.0 mg Semaglutide-18.211.30
30 mg/kg Bimagrumab + 2.4 mg Semaglutide-21.261.26
Secondary outcomeLeast squares mean· Baseline, Week 48

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

GroupValue (Kilogram (kg))Spread
Placebo/30 mg/kg Bimagrumab-2.410.76
10/30 mg/kg Bimagrumab-6.900.88
30 mg/kg Bimagrumab-11.861.03
Placebo + 1.0 mg Semaglutide-7.490.96
Placebo + 2.4 mg Semaglutide-11.060.86
10 mg/kg Bimagrumab + 1.0 mg Semaglutide-14.170.84
10 mg/kg Bimagrumab + 2.4 mg Semaglutide-15.930.85
30 mg/kg Bimagrumab + 1.0 mg Semaglutide-15.330.94
30 mg/kg Bimagrumab + 2.4 mg Semaglutide-19.300.82
Secondary outcomeLeast squares mean· Baseline, Week 72

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

GroupValue (Kilogram (kg))Spread
Placebo/30 mg/kg Bimagrumab-7.330.87
10/30 mg/kg Bimagrumab-7.841.17
30 mg/kg Bimagrumab-13.241.19
Placebo + 1.0 mg Semaglutide-7.661.08
Placebo + 2.4 mg Semaglutide-12.471.07
10 mg/kg Bimagrumab + 1.0 mg Semaglutide-15.851.10
10 mg/kg Bimagrumab + 2.4 mg Semaglutide-17.521.13
30 mg/kg Bimagrumab + 1.0 mg Semaglutide-16.721.19
30 mg/kg Bimagrumab + 2.4 mg Semaglutide-21.241.13
Secondary outcomeLeast squares mean· Baseline, Week 48

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

GroupValue (Percent change)Spread
Placebo/30 mg/kg Bimagrumab-5.531.59
10/30 mg/kg Bimagrumab-15.651.97
30 mg/kg Bimagrumab-25.232.20
Placebo + 1.0 mg Semaglutide-18.362.28
Placebo + 2.4 mg Semaglutide-24.571.57
10 mg/kg Bimagrumab + 1.0 mg Semaglutide-30.601.70
10 mg/kg Bimagrumab + 2.4 mg Semaglutide-35.851.91
30 mg/kg Bimagrumab + 1.0 mg Semaglutide-34.422.02
30 mg/kg Bimagrumab + 2.4 mg Semaglutide-42.061.81
Secondary outcomeLeast squares mean· Baseline, Week 72

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

GroupValue (Percent change)Spread
Placebo/30 mg/kg Bimagrumab-16.602.11
10/30 mg/kg Bimagrumab-18.452.65
30 mg/kg Bimagrumab-28.352.45
Placebo + 1.0 mg Semaglutide-18.972.55
Placebo + 2.4 mg Semaglutide-27.372.11
10 mg/kg Bimagrumab + 1.0 mg Semaglutide-33.582.12
10 mg/kg Bimagrumab + 2.4 mg Semaglutide-39.462.46
30 mg/kg Bimagrumab + 1.0 mg Semaglutide-37.262.48
30 mg/kg Bimagrumab + 2.4 mg Semaglutide-45.422.12
Secondary outcomeLeast squares mean· Baseline, Week 48

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

GroupValue (kg)Spread
Placebo/30 mg/kg Bimagrumab-0.050.06
10/30 mg/kg Bimagrumab-0.360.04
30 mg/kg Bimagrumab-0.610.06
Placebo + 1.0 mg Semaglutide-0.300.05
Placebo + 2.4 mg Semaglutide-0.430.05
10 mg/kg Bimagrumab + 1.0 mg Semaglutide-0.640.06
10 mg/kg Bimagrumab + 2.4 mg Semaglutide-0.830.07
30 mg/kg Bimagrumab + 1.0 mg Semaglutide-0.750.07
30 mg/kg Bimagrumab + 2.4 mg Semaglutide-0.820.06

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Placebo/30 mg/kg BimagrumabParticipants 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 64.0 / 555 / 5546 / 55
10/30 mg/kg BimagrumabParticipants 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 64.0 / 569 / 5654 / 56
30 mg/kg BimagrumabParticipants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64.0 / 578 / 5754 / 57
Placebo + 1.0 mg SemaglutideParticipants 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 mg0 / 554 / 5552 / 55
Placebo + 2.4 mg SemaglutideParticipants 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 mg0 / 568 / 5652 / 56
10 mg/kg Bimagrumab + 1.0 mg SemaglutideParticipants 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 mg0 / 567 / 5653 / 56
10 mg/kg Bimagrumab + 2.4 mg SemaglutideParticipants 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 mg0 / 558 / 5554 / 55
30 mg/kg Bimagrumab + 1.0 mg SemaglutideParticipants 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 mg0 / 566 / 5654 / 56
30 mg/kg Bimagrumab + 2.4 mg SemaglutideParticipants 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 mg0 / 557 / 5554 / 55

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2026

6 results

Bimagrumab plus semaglutide alone or in combination for the treatment of obesity: a randomized phase 2 trial.

Heymsfield et al. 2026Nature medicinecited by 46

PMID 41772149PMC13004672DOI 10.1038/s41591-026-04204-0PUB-41772149

CC BY6 results
Download PDFSee results (6)

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedMoon 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. PMID 40230053

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 80 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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