Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Bimagrumab, BYM338, VER201
LY3985863 · 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...
LY3985863 is an investigational monoclonal antibody being developed by Eli Lilly and Company. It has been studied in a Phase 1 clinical trial in healthy participants. The specific disease or condition it is intended to treat has not been disclosed.
LY3985863 is being developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. Lilly is the sponsor of the clinical program evaluating this monoclonal antibody.
LY3985863 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The program remains investigational and has not been approved by the FDA for any indication.
LY3985863 has been evaluated in one Phase 1 trial, NCT07030127, titled A Study of LY3985863 in Healthy Participants. The trial was completed, enrolled 24 participants, was randomized, double-blind, and placebo-controlled, and was conducted in China.
The therapeutic use of LY3985863 has not been disclosed. It is an investigational monoclonal antibody that has only been studied in healthy volunteers in a Phase 1 trial, so no approved or established indication exists for this drug candidate.