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Also known as LY3985863, BYM338, VER201
Bimagrumab · 3 trials · 5 indications
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.
A summary of TEAEs and SAEs regardless of causality, will be reported in the Reported Adverse Events module
| Arm | Type | Description |
|---|---|---|
| Part A: Bimagrumab Dose 2 + Tirzepatide Placebo | EXPERIMENTAL | Participants will receive bimagrumab subcutaneously (SC) and tirzepatide placebo SC |
| Part A: Bimagrumab Placebo + Tirzepatide Dose 1 | ACTIVE_COMPARATOR | Participants will receive bimagrumab placebo SC and tirzepatide SC |
| Part A: Bimagrumab Placebo + Tirzepatide Dose 2 | ACTIVE_COMPARATOR | Participants will receive bimagrumab placebo SC and tirzepatide SC |
| Part A: Bimagrumab Dose 1 + Tirzepatide Dose 1 | EXPERIMENTAL | Participants will receive bimagrumab SC and tirzepatide SC |
| Part A: Bimagrumab Dose 1 + Tirzepatide Dose 2 | EXPERIMENTAL | Participants will receive bimagrumab SC and tirzepatide SC |
| Part A: Bimagrumab Dose 2 + Tirzepatide Dose 2 | EXPERIMENTAL | Participants will receive bimagrumab SC and tirzepatide SC |
| Part A: Bimagrumab Placebo + Tirzepatide Placebo | PLACEBO_COMPARATOR | Participants will receive bimagrumab placebo SC and tirzepatide placebo SC |
| Part B: Bimagrumab Dose 2 (no titration) + Tirzepatide Dose 1 | EXPERIMENTAL | Participants will receive bimagrumab SC and tirzepatide SC |
| Part B: Bimagrumab Dose 2 (fast titration) + Tirzepatide Dose 1 | EXPERIMENTAL | Participants will receive bimagrumab SC and tirzepatide SC |
| Part B: Bimagrumab Dose 2 (slow titration) + Tirzepatide Dose 1 | EXPERIMENTAL | Participants will receive bimagrumab SC and tirzepatide SC |
| Part B: Bimagrumab Dose 1 + Tirzepatide Placebo | EXPERIMENTAL | Participants will receive bimagrumab SC and tirzepatide placebo SC |
| Part B: Bimagrumab Placebo + Tirzepatide Placebo | PLACEBO_COMPARATOR | Participants will receive bimagrumab placebo SC and tirzepatide placebo SC |
| 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. |
| 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. |
| 30 mg/kg Bimagrumab | EXPERIMENTAL | Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64. |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| LY3985863 | EXPERIMENTAL | Administered subcutaneously (SC) |
| Placebo | PLACEBO_COMPARATOR | Administered SC |
| Name | Type | Description |
|---|---|---|
| Bimagrumab | DRUG | Administered SC |
| Tirzepatide | DRUG | Administered SC |
| Bimagrumab Placebo | DRUG | Administered SC |
| Tirzepatide Placebo | DRUG | Administered SC |
| Semaglutide | DRUG | Glucagon-like peptide-1 (GLP-1) receptor agonist |
| Placebo | OTHER | Placebo |
| LY3985863 | DRUG | Administered SC |
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...
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Bimagrumab is an investigational monoclonal antibody being studied for weight management in adults with obesity or overweight. It is in Phase 2 clinical development and is not approved for any indication. The clinical program evaluates it both alone and in combination with other agents for obesity and overweight.
Bimagrumab targets ACVR2B, also known as activin receptor type IIB. It acts as an antagonist at this receptor. By blocking ACVR2B signaling, the antibody is designed to affect pathways involved in muscle and fat regulation, which is the basis for its study in obesity and overweight.
Bimagrumab is being developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. The company is running the Phase 2 clinical program for the asset in obesity and overweight, including a combination study with tirzepatide.
Bimagrumab is in Phase 2 clinical development. It is investigational and has not been approved by the FDA for any indication. Two Phase 2 trials have been conducted in obesity and overweight, one of which is completed and one of which is active but not recruiting.
Bimagrumab has been studied in two Phase 2 trials. NCT06643728 is an active, not recruiting study of weight management with bimagrumab (LY3985863) and tirzepatide (LY3298176), alone or in combination, in adults with obesity or overweight. NCT05616013 is a completed Phase 2 trial of bimagrumab and semaglutide in adults who are overweight or obese.
Yes. Bimagrumab is also known as LY3985863, which is the Eli Lilly development code used for the asset. The name LY3985863 appears in the title of the Phase 2 trial NCT06643728, which studies bimagrumab and tirzepatide in adults with obesity or overweight.