Trial · NCT05616013
Safety and Efficacy of Bimagrumab and Semaglutide in Adults Who Are Overweight or Obese
NCT05616013, Phase 2, Completed, Eli Lilly and Company; results first posted 2025-07-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy of Bimagrumab and Semaglutide in Adults Who Are Overweight or Obese. Trials, record NCT05616013. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05616013
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of Bimagrumab and Semaglutide in Adults Who Are Overweight or Obese
- NCT number
- NCT05616013
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 507 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Obesity, Obese, Overweight or Obesity
- Interventions
- Bimagrumab, Semaglutide, Placebo
- First posted
- 2022-11-14
- Last updated
- 2026-07-08
- Results first posted
- 2025-07-18
Source ClinicalTrials.gov
Registered outcomes42
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Body Weight at Week 48 | Baseline, Week 48 | Least Square mean was determined by MMRM model for post-baseline measures: Variable is modelled by Gender (Male, Female), Country (Australia, New Zealand, United States of America), Visit, Treatment, and Visit-by-Treatment interaction as fixed effects, and Baseline as a covariate. Variance-Covariance structure= Unstructured. Only participants with non-missing baseline value were included in analysis. No imputation was performed for missing values. |
| Secondary | Change From Baseline in Waist Circumference at Week 48 | Baseline, Week 48 | Waist circumference was measured in standing position with a non-stretchable measuring tape to the nearest 0.1 centimeter (cm). Least Square mean was determined by mixed model repeated measures (MMRM) model for post-baseline measures: Variable is modelled by Gender (Male, Female), Country (Australia, New Zealand, United States of America), Visit, Treatment, and Visit-by-Treatment interaction as fixed effects, and Baseline as a covariate. Variance-Covariance structure= Unstructured. Only participants with non-missing baseline value were included in analysis. No imputation was performed for missing values. |
| Secondary | Change From Baseline in Waist Circumference at Week 72 | Baseline, Week 72 | Waist circumference was measured in standing position with a non-stretchable measuring tape to the nearest 0.1 cm. Least Square mean was determined by mixed model repeated measures (MMRM) model for post-baseline measures: Variable is modelled by Gender (Male, Female), Country (Australia, New Zealand, United States of America), Visit, Treatment, and Visit-by-Treatment interaction as fixed effects, and Baseline as a covariate. Variance-Covariance structure= Unstructured. Only participants with non-missing baseline value were included in analysis. No imputation was performed for missing values. |
| Secondary | Change From Baseline in Total Body Fat Mass in Kilograms (kg) at Week 48 | Baseline, Week 48 | Change from baseline in total body fat mass in kg was assessed by Dual energy X-ray absorptiometry (DXA). Least Square mean was determined by mixed model repeated measures (MMRM) model for post-baseline measures: Variable is modelled by Gender (Male, Female), Country (Australia, New Zealand, United States of America), Visit, Treatment, and Visit-by-Treatment interaction as fixed effects, and Baseline as a covariate. Variance-Covariance structure= Unstructured. Only participants with non-missing baseline value were included in analysis. No imputation was performed for missing values. |
| Secondary | Change From Baseline in Total Body Fat Mass in kg at Week 72 | Baseline, Week 72 | Change from baseline in total body fat mass in kg was assessed by DXA. Least Square mean was determined by mixed model repeated measures (MMRM) model for post-baseline measures: Variable is modelled by Gender (Male, Female), Country (Australia, New Zealand, United States of America), Visit, Treatment, and Visit-by-Treatment interaction as fixed effects, and Baseline as a covariate. Variance-Covariance structure= Unstructured. Only participants with non-missing baseline value were included in analysis. No imputation was performed for missing values. |
| Secondary | Percent Change From Baseline for Fat Mass by DXA at Week 48 | Baseline, Week 48 | Percent change from baseline for fat mass was assessed by DXA. Least Square mean was determined by MMRM model for post-baseline measures: Variable is modelled by Gender (Male, Female), Country (Australia, New Zealand, United States of America), Visit, Treatment, and Visit-by-Treatment interaction as fixed effects, and Baseline as a covariate. Variance-Covariance structure= Unstructured. Only participants with non-missing baseline value were included in analysis. No imputation was performed for missing values. |
| Secondary | Percent Change From Baseline for Fat Mass by DXA at Week 72 | Baseline, Week 72 | Percent change from baseline for fat mass was assessed by DXA. Least Square mean was determined by MMRM model for post-baseline measures: Variable is modelled by Gender (Male, Female), Country (Australia, New Zealand, United States of America), Visit, Treatment, and Visit-by-Treatment interaction as fixed effects, and Baseline as a covariate. Variance-Covariance structure= Unstructured. Only participants with non-missing baseline value were included in analysis. No imputation was performed for missing values. |
| Secondary | Change From Baseline in Visceral Adipose Tissue (VAT), Subcutaneous Adipose Tissue (SAT) and Trunk Fat Mass by DXA at Week 48 | Baseline, Week 48 | Change from baseline in VAT, SAT and trunk fat mass was assessed by DXA. Least Square mean was determined by MMRM model for post-baseline measures: Variable is modelled by Gender (Male, Female), Country (Australia, New Zealand, United States of America), Visit, Treatment, and Visit-by-Treatment interaction as fixed effects, and Baseline as a covariate. Variance-Covariance structure= Unstructured. Only participants with non-missing baseline value were included in analysis. No imputation was performed for missing values. |
| Secondary | Change From Baseline in VAT, SAT and Trunk Fat Mass by DXA at Week 72 | Baseline, Week 72 | Change from baseline in VAT, SAT and trunk fat mass was assessed by DXA. Least Square mean was determined by MMRM model for post-baseline measures: Variable is modelled by Gender (Male, Female), Country (Australia, New Zealand, United States of America), Visit, Treatment, and Visit-by-Treatment interaction as fixed effects, and Baseline as a covariate. Variance-Covariance structure= Unstructured. Only participants with non-missing baseline value were included in analysis. No imputation was performed for missing values. |
| Secondary | Percentage of Participants With Reduction in Waist Circumference Greater Than or Equal to (≥) 5 cm at Week 48 | Week 48 | Waist circumference was measured in a standing position with a non-stretchable measuring tape to the nearest 0.1 cm. Only participants with non-missing baseline value were included in analysis. |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 registered outcomesOutcomes41
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Body Weight at Week 48 | Baseline, Week 48 | All randomized participants who received at least one dose of the study drug, had a baseline and at least one post- baseline value for this outcome. | kilogram (kg) | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Waist Circumference at Week 48 | Baseline, Week 48 | All randomized participants who received at least one dose of the study drug, had a baseline and at least one post- baseline value for this outcome. | centimeter (cm) | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Waist Circumference at Week 72 | Baseline, Week 72 | |||
| SECONDARY | Change From Baseline in Total Body Fat Mass in Kilograms (kg) at Week 48 | Baseline, Week 48 | All randomized participants who received at least one dose of the study drug, had a baseline and at least one post- baseline value for this outcome. | kg | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Total Body Fat Mass in kg at Week 72 | Baseline, Week 72 | |||
| SECONDARY | Change From Baseline in Body Fat Percentage at Week 48 | Baseline, Week 48 | All randomized participants who received at least one dose of the study drug, had a baseline and at least one post- baseline value for this outcome. | percentage of body fat | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Body Fat Percentage at Week 72 | Baseline, Week 72 | |||
| SECONDARY | Change From Baseline in Visceral Adipose Tissue (VAT), Subcutaneous Adipose Tissue (SAT) and Trunk Fat Mass by DXA at Week 48 | Baseline, Week 48 | All randomized participants who received at least one dose of the study drug, had a baseline and at least one post- baseline value for this outcome. | kg | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in VAT, SAT and Trunk Fat Mass by DXA at Week 72 | Baseline, Week 72 | |||
| SECONDARY | Percentage of Participants With Reduction in Waist Circumference ≥ 5 cm at Week 48 | Week 48 | All randomized participants who received at least one dose of the study drug and had evaluable data for this outcome. | percentage of participants | NUMBER |
1 to 10 of 41Source ClinicalTrials.gov
See all 41 outcomesResults by group444
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Body Weight at Week 48 | Placebo | -3.31 | Standard Error 1.39 | kilogram (kg) | |
| Change From Baseline in Body Weight at Week 48 | Bimagrumab 10 mg/kg | -5.99 | Standard Error 1.42 | kilogram (kg) | |
| Change From Baseline in Body Weight at Week 48 | Bimagrumab 30 mg/kg | -9.25 | Standard Error 1.33 | kilogram (kg) | |
| Change From Baseline in Body Weight at Week 48 | Placebo + Semaglutide 1.0 mg | -9.76 | Standard Error 1.25 | kilogram (kg) | |
| Change From Baseline in Body Weight at Week 48 | Placebo + Semaglutide 2.4 mg | -14.24 | Standard Error 1.17 | kilogram (kg) | |
| Change From Baseline in Body Weight at Week 48 | Bimagrumab 10 mg/kg + Semaglutide 1.0 mg | -12.73 | Standard Error 1.29 | kilogram (kg) | |
| Change From Baseline in Body Weight at Week 48 | Bimagrumab 10 mg/kg + Semaglutide 2.4 mg | -14.31 | Standard Error 1.34 | kilogram (kg) | |
| Change From Baseline in Body Weight at Week 48 | Bimagrumab 30 mg/kg + Semaglutide 1.0 mg | -13.86 | Standard Error 1.29 | kilogram (kg) | |
| Change From Baseline in Body Weight at Week 48 | Bimagrumab 30 mg/kg + Semaglutide 2.4 mg | -17.79 | Standard Error 1.29 | kilogram (kg) | |
| Change From Baseline in Waist Circumference at Week 48 | Placebo | -4.62 | Standard Error 1.59 | centimeter (cm) |
1 to 10 of 444Source ClinicalTrials.gov
See all 444 results by groupParticipant flow36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 56 | |
| Overall Study | STARTED | Bimagrumab 10 mg/kg | 56 | |
| Overall Study | STARTED | Bimagrumab 30 mg/kg | 57 | |
| Overall Study | STARTED | Placebo + Semaglutide 1.0 mg | 56 | |
| Overall Study | STARTED | Placebo + Semaglutide 2.4 mg | 57 | |
| Overall Study | STARTED | Bimagrumab 10 mg/kg + Semaglutide 1.0 mg | 56 | |
| Overall Study | STARTED | Bimagrumab 10 mg/kg + Semaglutide 2.4 mg | 56 | |
| Overall Study | STARTED | Bimagrumab 30 mg/kg + Semaglutide 1.0 mg | 56 | |
| Overall Study | STARTED | Bimagrumab 30 mg/kg + Semaglutide 2.4 mg | 57 | |
| Overall Study | Safety Analysis Population (Received at Least 1 Dose of Study Drug) | Placebo | 55 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 participant flowAdverse events5,274
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 0 | 55 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Bimagrumab 10 mg/kg | 0 | 56 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Bimagrumab 30 mg/kg | 1 | 57 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Placebo + Semaglutide 1.0 mg | 1 | 55 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Placebo + Semaglutide 2.4 mg | 1 | 56 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Bimagrumab 10 mg/kg + Semaglutide 1.0 mg | 1 | 56 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Bimagrumab 10 mg/kg + Semaglutide 2.4 mg | 0 | 55 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Bimagrumab 30 mg/kg + Semaglutide 1.0 mg | 2 | 56 | 2 |
| other | Anaemia | Blood and lymphatic system disorders | Bimagrumab 30 mg/kg + Semaglutide 2.4 mg | 1 | 55 | 1 |
| other | Increased tendency to bruise | Blood and lymphatic system disorders | Placebo | 1 | 55 | 1 |
1 to 10 of 5,274Source ClinicalTrials.gov
See all 5,274 adverse eventsAdverse event totals27
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 55 |
| Total, all-cause mortality | Bimagrumab 10 mg/kg | 0 | 56 |
| Total, all-cause mortality | Bimagrumab 30 mg/kg | 0 | 57 |
| Total, all-cause mortality | Placebo + Semaglutide 1.0 mg | 0 | 55 |
| Total, all-cause mortality | Placebo + Semaglutide 2.4 mg | 0 | 56 |
| Total, all-cause mortality | Bimagrumab 10 mg/kg + Semaglutide 1.0 mg | 0 | 56 |
| Total, all-cause mortality | Bimagrumab 10 mg/kg + Semaglutide 2.4 mg | 0 | 55 |
| Total, all-cause mortality | Bimagrumab 30 mg/kg + Semaglutide 1.0 mg | 0 | 56 |
| Total, all-cause mortality | Bimagrumab 30 mg/kg + Semaglutide 2.4 mg | 0 | 55 |
| Total, other adverse events | Placebo | 41 | 55 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05616013
GET https://conductscience.org/api/trials/v1/NCT05616013/registered?page=2