Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06643728 | A Study to Investigate Weight Management With Bimagrumab (LY3985863) and Tirzepatide (LY3298176), Alone or in Combination, in Adults With Obesity or Overweight | PHASE2 | ACTIVE NOT_RECRUITING | 252 | — | — | Oct 21, 2024 | Jan 1, 2027 | May 26, 2026 | 12 | United States |
| NCT05616013 | Safety and Efficacy of Bimagrumab and Semaglutide in Adults Who Are Overweight or Obese | PHASE2 | COMPLETED | 507 | — | — | Nov 16, 2022 | Jun 14, 2025 | Jul 18, 2025 | 26 | United States, Australia +1 |
Least square (LS) Mean was determined by analysis of covariance (ANCOVA) model using Baseline + Gender (Male, Female) + Country (Australia, New Zealand, United States of America) + Treatment (Type III sum of squares) as variables. Only participants with non-missing baseline value were included in analysis. Missing values at Week 48 were imputed 100 times based on observed data in the Placebo arm
| 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 | PLACEBO_COMPARATOR | Participants received a placebo administered intravenously (IV) at baseline and at weeks 4, 16, 28, and 40 during the core treatment period. |
| Bimagrumab 10 mg/kg | EXPERIMENTAL | Participants received bimagrumab 10 milligrams/kilogram (mg/kg) administered IV at baseline and at weeks 4, 16, 28, and 40 during the core treatment period. |
| Bimagrumab 30 mg/kg | EXPERIMENTAL | Participants received bimagrumab 30 mg/kg administered IV at baseline and at weeks 4, 16, 28, and 40. |
| Placebo + Semaglutide 1.0 mg | EXPERIMENTAL | Participants received a placebo administered IV at baseline and at Weeks 4, 16, 28, and 40, and 1 milligram (mg) of semaglutide administered subcutaneously (SC) weekly for 48 weeks as per the below dose escalation schedule: Weeks 1 to 4: 0.25 mg Weeks 5 to 8: 0.5 mg Weeks 9 to 48: 1.0 mg |
| Placebo + Semaglutide 2.4 mg | EXPERIMENTAL | Participants received a placebo administered IV at baseline and at weeks 4, 16, 28, and 40, and 2.4 mg semaglutide administered SC weekly for 48 weeks 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 48: 2.4 mg. |
| Bimagrumab 10 mg/kg + Semaglutide 1.0 mg | EXPERIMENTAL | Participants received bimagrumab 10 mg/kg administered IV at baseline and at weeks 4, 16, 28, and 40, and 1 mg semaglutide administered SC weekly for 48 weeks as per the below dose escalation schedule: Weeks 1 to 4: 0.25 mg Weeks 5 to 8: 0.5 mg Weeks 9 to 48: 1.0 mg. |
| Bimagrumab 10 mg/kg + Semaglutide 2.4 mg | EXPERIMENTAL | Participants received bimagrumab 10 mg/kg administered IV at baseline and at weeks 4, 16, 28, and 40, and 2.4 mg semaglutide administered SC weekly for 48 weeks 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 48: 2.4 mg. |
| Bimagrumab 30 mg/kg + Semaglutide 1.0 mg | EXPERIMENTAL | Participants received bimagrumab 30 mg/kg administered IV at baseline and at weeks 4, 16, 28, and 40, and 1 mg semaglutide administered SC weekly for 48 weeks as per the below dose escalation schedule: Weeks 1 to 4: 0.25 mg Weeks 5 to 8: 0.5 mg Weeks 9 to 48: 1.0 mg |
| Bimagrumab 30 mg/kg + semaglutide 2.4 mg | EXPERIMENTAL | Participants received bimagrumab 30 mg/kg administered IV at baseline and at weeks 4, 16, 28 and 40, and 2.4 mg semaglutide administered SC weekly for 48 weeks 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 48: 2.4 mg. |
| 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 |
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...