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Bimagrumab

Phase 2

Obesity | Small molecule | Metabolic |Eli Lilly and Company|Last Updated: Jul 8, 2026

Target and mechanism

Molecular targetACVR2B
Target classAntagonist
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials2
Total Enrollment759

FDA Designations

No designations recorded

Clinical trial landscape

Bimagrumab · 3 trials · 5 indications

Phase 2 2Phase 1 1
NCT06643728A Study to Investigate Weight Management With Bimagrumab (LY3985863) and Tirzepatide (LY3298176), Alone or in Combination, in Adults With Obesity or OverweightObesity
ACTIVE NOT_RECRUITING252 Analytics
NCT05616013Safety and Efficacy of Bimagrumab and Semaglutide in Adults Who Are Overweight or ObeseObesity
COMPLETED507 Analytics
PHASE2ACTIVE NOT_RECRUITING
A Study to Investigate Weight Management With Bimagrumab (LY3985863) and Tirzepatide (LY3298176), Alone or in Combination, in Adults With Obesity or Overweight
ObesityUnlock trial analytics
PHASE2COMPLETED
Safety and Efficacy of Bimagrumab and Semaglutide in Adults Who Are Overweight or Obese
ObesityUnlock trial analytics

Study Endpoints

Primary Endpoints

Percent Change from Baseline in Body Weight
Baseline, Week 24
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.

Pharmacokinetics (PK): Maximum Concentration (Cmax) of Bimagrumab Test Material
Predose through Week 13
PK: Cmax of Bimagrumab Reference Material
Predose through Week 13
PK: Cmax of Bimagrumab Coadministered with Tirzepatide
Predose through Week 13
PK: Cmax of Tirzepatide Coadministered with Bimagrumab
Predose through Week 16
PK: Cmax of Bimagrumab Coformulated with Tirzepatide
Predose through Week 16
PK: Cmax of Tirzepatide Coformulated with Bimagrumab
Predose through Week 16
PK: Area Under the Curve from Zero to Infinity AUC (AUC(0-∞)) of Bimagrumab Test Material
Predose through Week 13
PK: AUC(0-∞) of Bimagrumab Reference Material
Predose through Week 13
PK: AUC(0-∞) of Bimagrumab Coadministered with Tirzepatide
Predose through Week 13
PK: AUC(0-∞) of Tirzepatide Coadministered with Bimagrumab
Predose through Week 16
PK: AUC(0-∞) of Bimagrumab Coformulated with Tirzepatide
Predose through Week 16
PK: AUC(0-∞) of Tirzepatide Coformulated with Bimagrumab
Predose through Week 16

Secondary Endpoints

Percent Change from Baseline in Total Body Fat Mass by Dual-Energy X-Ray Absorptiometry (DXA)
Baseline, Week 24, Week 48
Change from Baseline in Body Weight
Baseline, Week 24, Week 48
Percentage of Participants Achieving ≥5% Body Weight Reduction
Baseline, Week 24, Week 48
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part A: Bimagrumab Dose 2 + Tirzepatide PlaceboEXPERIMENTALParticipants will receive bimagrumab subcutaneously (SC) and tirzepatide placebo SC
Part A: Bimagrumab Placebo + Tirzepatide Dose 1ACTIVE_COMPARATORParticipants will receive bimagrumab placebo SC and tirzepatide SC
Part A: Bimagrumab Placebo + Tirzepatide Dose 2ACTIVE_COMPARATORParticipants will receive bimagrumab placebo SC and tirzepatide SC
Part A: Bimagrumab Dose 1 + Tirzepatide Dose 1EXPERIMENTALParticipants will receive bimagrumab SC and tirzepatide SC
Part A: Bimagrumab Dose 1 + Tirzepatide Dose 2EXPERIMENTALParticipants will receive bimagrumab SC and tirzepatide SC
Part A: Bimagrumab Dose 2 + Tirzepatide Dose 2EXPERIMENTALParticipants will receive bimagrumab SC and tirzepatide SC
Part A: Bimagrumab Placebo + Tirzepatide PlaceboPLACEBO_COMPARATORParticipants will receive bimagrumab placebo SC and tirzepatide placebo SC
Part B: Bimagrumab Dose 2 (no titration) + Tirzepatide Dose 1EXPERIMENTALParticipants will receive bimagrumab SC and tirzepatide SC
Part B: Bimagrumab Dose 2 (fast titration) + Tirzepatide Dose 1EXPERIMENTALParticipants will receive bimagrumab SC and tirzepatide SC
Part B: Bimagrumab Dose 2 (slow titration) + Tirzepatide Dose 1EXPERIMENTALParticipants will receive bimagrumab SC and tirzepatide SC
Part B: Bimagrumab Dose 1 + Tirzepatide PlaceboEXPERIMENTALParticipants will receive bimagrumab SC and tirzepatide placebo SC
Part B: Bimagrumab Placebo + Tirzepatide PlaceboPLACEBO_COMPARATORParticipants will receive bimagrumab placebo SC and tirzepatide placebo SC
Placebo/30 mg/kg BimagrumabPLACEBO_COMPARATORParticipants 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.
10/30 mg/kg BimagrumabEXPERIMENTALParticipants 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.
30 mg/kg BimagrumabEXPERIMENTALParticipants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64.
Placebo + 1.0 mg SemaglutideEXPERIMENTALParticipants 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
Placebo + 2.4 mg SemaglutideEXPERIMENTALParticipants 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
10 mg/kg Bimagrumab + 1.0 mg SemaglutideEXPERIMENTALParticipants 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
10 mg/kg Bimagrumab + 2.4 mg SemaglutideEXPERIMENTALParticipants 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
30 mg/kg Bimagrumab + 1.0 mg SemaglutideEXPERIMENTALParticipants 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
30 mg/kg Bimagrumab + 2.4 mg SemaglutideEXPERIMENTALParticipants 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
Bimagrumab Dose 1 Reference MaterialEXPERIMENTALParticipants will receive a single dose of bimagrumab subcutaneously (SC)
Bimagrumab Dose 1 Test Material + Tirzepatide (Coadministration)EXPERIMENTALParticipants will receive a single dose of bimagrumab SC and a single dose of tirzepatide SC
Bimagrumab Dose 1 Test Material + Tirzepatide (Coformulation)EXPERIMENTALParticipants will receive a single dose of bimagrumab with tirzepatide SC
Bimagrumab Dose 2 Test Material + Tirzepatide (Coadministration)EXPERIMENTALParticipants will receive bimagrumab SC and tirzepatide SC for 4 weeks
Bimagrumab Dose 2 Test Material + Tirzepatide (Coformulation)EXPERIMENTALParticipants will receive bimagrumab with tirzepatide SC for 4 weeks

Interventions

NameTypeDescription
BimagrumabDRUGAdministered SC
TirzepatideDRUGAdministered SC
Bimagrumab PlaceboDRUGAdministered SC
Tirzepatide PlaceboDRUGAdministered SC
SemaglutideDRUGGlucagon-like peptide-1 (GLP-1) receptor agonist
PlaceboOTHERPlacebo
Bimagrumab + Tirzepatide CoformulationDRUGAdministered SC
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites12

Inclusion Criteria: * Have a BMI of * ≥30 kilograms per square meter (kg/m2) or * ≥27 kg/m2 and \<30 kg/m2, with at least one of the following weight-related comorbidities: * Hypertension * Dyslipidemia * Cardiovascular disease * Obstructive sleep apnea * Have had a stable bod...

Countries:United StatesAustraliaNew Zealand
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Recent Changes (Last 90 Days)

MEDIUMAug 8, 2026NCT05616013TRIAL_REMOVED: changed
MEDIUMAug 8, 2026NCT05616013TRIAL_REMOVED: changed
MEDIUMAug 8, 2026NCT05616013TRIAL_REMOVED: changed
MEDIUMAug 8, 2026NCT05616013TRIAL_REMOVED: changed

Frequently asked questions about Bimagrumab

What is Bimagrumab used for?

Bimagrumab is an investigational antibody being studied for weight management in adults with obesity or overweight. It is also being evaluated in healthy participants. The drug is being tested alone and in combination with other weight-management medications, including semaglutide and tirzepatide.

What does Bimagrumab target?

Bimagrumab is a monoclonal antibody, indicated by its -mab suffix. It is being studied for its effects on weight management in obesity. The specific molecular target is not disclosed in the available clinical trial information.

Who makes Bimagrumab?

Bimagrumab is being developed by Eli Lilly and Company, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol LLY. The company is conducting clinical trials to evaluate the drug's safety and efficacy in weight management.

What phase is Bimagrumab in?

Bimagrumab is in Phase 1 clinical development. It has completed one Phase 1 trial in healthy participants and is also being studied in Phase 2 trials for obesity and overweight. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is Bimagrumab in?

Bimagrumab has been studied in three clinical trials. NCT05616013 evaluated bimagrumab with semaglutide in overweight or obese adults. NCT06643728 is an active study of bimagrumab with tirzepatide in obesity. NCT06890611 was a completed Phase 1 study in healthy participants.

Is Bimagrumab the same as LY3985863?

Yes, Bimagrumab is also known as LY3985863. Clinical trial records use both names to refer to the same investigational drug. In studies combining it with tirzepatide, the combination is sometimes referred to as LY900042.