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

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 Placebo
    Participants will receive bimagrumab subcutaneously (SC) and tirzepatide placebo SC
  • Active Comparator: Part A: Bimagrumab Placebo + Tirzepatide Dose 1
    Participants will receive bimagrumab placebo SC and tirzepatide SC
  • Active Comparator: Part A: Bimagrumab Placebo + Tirzepatide Dose 2
    Participants will receive bimagrumab placebo SC and tirzepatide SC
  • Experimental: Part A: Bimagrumab Dose 1 + Tirzepatide Dose 1
    Participants will receive bimagrumab SC and tirzepatide SC
  • Experimental: Part A: Bimagrumab Dose 1 + Tirzepatide Dose 2
    Participants will receive bimagrumab SC and tirzepatide SC
  • Experimental: Part A: Bimagrumab Dose 2 + Tirzepatide Dose 2
    Participants will receive bimagrumab SC and tirzepatide SC
  • Placebo Comparator: Part A: Bimagrumab Placebo + Tirzepatide Placebo
    Participants will receive bimagrumab placebo SC and tirzepatide placebo SC
  • Experimental: Part B: Bimagrumab Dose 2 (no titration) + Tirzepatide Dose 1
    Participants will receive bimagrumab SC and tirzepatide SC
  • Experimental: Part B: Bimagrumab Dose 2 (fast titration) + Tirzepatide Dose 1
    Participants will receive bimagrumab SC and tirzepatide SC
  • Experimental: Part B: Bimagrumab Dose 2 (slow titration) + Tirzepatide Dose 1
    Participants will receive bimagrumab SC and tirzepatide SC
  • Experimental: Part B: Bimagrumab Dose 1 + Tirzepatide Placebo
    Participants will receive bimagrumab SC and tirzepatide placebo SC
  • Placebo Comparator: Part B: Bimagrumab Placebo + Tirzepatide Placebo
    Participants 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)

FacilityCityStateZIPSite coordinators
Pinnacle Research Group, LLCAnnistonAlabama36207-
Central Research AssociatesBirminghamAlabama35205-
Diablo Clinical Research, Inc.Walnut CreekCalifornia94598-
Clinical Neuroscience Solutions, Inc. dba CNS HealthcareJacksonvilleFlorida32256-
Altus ResearchLake WorthFlorida33461-
Suncoast Research GroupMiamiFlorida33135-
East-West Medical Research InstituteHonoluluHawaii96814-
Great Lakes Clinical Trials - RavenswoodChicagoIllinois60640-
SKY Integrative Medical Center/SKYCRNGRidgelandMississippi39157-
Keystone Clinical StudiesPlymouth MeetingPennsylvania19462-
Eastside Research AssociatesRedmondWashington98052-
Rainier Clinical Research CenterRentonWashington98057-

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