A Study to Investigate Weight Management With Bimagrumab (LY3985863) and Tirzepatide (LY3298176), Alone or in Combination, in Adults With Obesity or Overweight
Part of paid clinical trials in Anniston, Alabama.
- Sponsor
- Eli Lilly and Company
- Study ID
- NCT06643728
- Phase
- PHASE2
- Status
- Active Not Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- Bimagrumab — DRUGAdministered SC
- Tirzepatide — DRUGAdministered SC
- Bimagrumab Placebo — DRUGAdministered SC
- Tirzepatide Placebo — DRUGAdministered SC
Study Details
The main purpose of this study is to evaluate the efficacy and safety of Bimagrumab and Tirzepatide, alone or in combination, in adults with obesity or overweight, with at least one obesity related comorbidity, without Type 2 Diabetes. The study will last about 70 weeks.
Key Dates
- Start date
- Oct 21, 2024
- Status verified
- May 2026
- Primary completion
- Jan 16, 2026
- Completion
- Jan 31, 2027
Study Design
- Enrollment
- 252 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Part A: Bimagrumab Dose 2 + Tirzepatide PlaceboParticipants will receive bimagrumab subcutaneously (SC) and tirzepatide placebo SC
- Active Comparator: Part A: Bimagrumab Placebo + Tirzepatide Dose 1Participants will receive bimagrumab placebo SC and tirzepatide SC
- Active Comparator: Part A: Bimagrumab Placebo + Tirzepatide Dose 2Participants will receive bimagrumab placebo SC and tirzepatide SC
- Experimental: Part A: Bimagrumab Dose 1 + Tirzepatide Dose 1Participants will receive bimagrumab SC and tirzepatide SC
- Experimental: Part A: Bimagrumab Dose 1 + Tirzepatide Dose 2Participants will receive bimagrumab SC and tirzepatide SC
- Experimental: Part A: Bimagrumab Dose 2 + Tirzepatide Dose 2Participants will receive bimagrumab SC and tirzepatide SC
- Placebo Comparator: Part A: Bimagrumab Placebo + Tirzepatide PlaceboParticipants will receive bimagrumab placebo SC and tirzepatide placebo SC
- Experimental: Part B: Bimagrumab Dose 2 (no titration) + Tirzepatide Dose 1Participants will receive bimagrumab SC and tirzepatide SC
- Experimental: Part B: Bimagrumab Dose 2 (fast titration) + Tirzepatide Dose 1Participants will receive bimagrumab SC and tirzepatide SC
- Experimental: Part B: Bimagrumab Dose 2 (slow titration) + Tirzepatide Dose 1Participants will receive bimagrumab SC and tirzepatide SC
- Experimental: Part B: Bimagrumab Dose 1 + Tirzepatide PlaceboParticipants will receive bimagrumab SC and tirzepatide placebo SC
- Placebo Comparator: Part B: Bimagrumab Placebo + Tirzepatide PlaceboParticipants will receive bimagrumab placebo SC and tirzepatide placebo SC
Primary Outcome Measure
Percent Change from Baseline in Body Weight [ Time Frame: Baseline, Week 24 ]
Locations (12)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Pinnacle Research Group, LLC | Anniston | Alabama | 36207 | - |
| Central Research Associates | Birmingham | Alabama | 35205 | - |
| Diablo Clinical Research, Inc. | Walnut Creek | California | 94598 | - |
| Clinical Neuroscience Solutions, Inc. dba CNS Healthcare | Jacksonville | Florida | 32256 | - |
| Altus Research | Lake Worth | Florida | 33461 | - |
| Suncoast Research Group | Miami | Florida | 33135 | - |
| East-West Medical Research Institute | Honolulu | Hawaii | 96814 | - |
| Great Lakes Clinical Trials - Ravenswood | Chicago | Illinois | 60640 | - |
| SKY Integrative Medical Center/SKYCRNG | Ridgeland | Mississippi | 39157 | - |
| Keystone Clinical Studies | Plymouth Meeting | Pennsylvania | 19462 | - |
| Eastside Research Associates | Redmond | Washington | 98052 | - |
| Rainier Clinical Research Center | Renton | Washington | 98057 | - |
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