Safety and Efficacy of Bimagrumab and Semaglutide in Adults Who Are Overweight or Obese

Part of paid clinical trials in Anniston, Alabama.

Sponsor
Eli Lilly and Company
Study ID
NCT05616013
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Bimagrumab — BIOLOGICAL
    Human monoclonal antibody to the activin receptor type II
  • Semaglutide — DRUG
    Glucagon-like peptide-1 (GLP-1) receptor agonist
  • Placebo — OTHER
    Placebo

Study Details

A phase 2 study to assess the efficacy of bimagrumab alone or in addition to semaglutide to assess efficacy and safety in overweight or obese men and women

Key Dates

Start date
Nov 16, 2022
Status verified
Jun 2025
Primary completion
May 16, 2024
Completion
Jun 14, 2025

Study Design

Enrollment
507 participants (actual)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo
    Participants received a placebo administered intravenously (IV) at baseline and at weeks 4, 16, 28, and 40 during the core treatment period.
  • Experimental: Bimagrumab 10 mg/kg
    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.
  • Experimental: Bimagrumab 30 mg/kg
    Participants received bimagrumab 30 mg/kg administered IV at baseline and at weeks 4, 16, 28, and 40.
  • Experimental: Placebo + Semaglutide 1.0 mg
    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
  • Experimental: Placebo + Semaglutide 2.4 mg
    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.
  • Experimental: Bimagrumab 10 mg/kg + Semaglutide 1.0 mg
    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.
  • Experimental: Bimagrumab 10 mg/kg + Semaglutide 2.4 mg
    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.
  • Experimental: Bimagrumab 30 mg/kg + Semaglutide 1.0 mg
    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
  • Experimental: Bimagrumab 30 mg/kg + semaglutide 2.4 mg
    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.

Primary Outcome Measure

Change From Baseline in Body Weight at Week 48 [ Time Frame: Baseline, Week 48 ]

Locations (10)

FacilityCityStateZIPSite coordinators
Pinnacle Research Group, LLCAnnistonAlabama36207-
Cullman Clinical TrialsCullmanAlabama35055-
Indago Research & Health Center, IncHialeahFlorida33012-
Clinical Neuroscience Solutions IncJacksonvilleFlorida32256-
Altus ResearchLake WorthFlorida33461-
Pennington Biomedical Research CenterBaton RougeLouisiana70808-
Weill Cornell Medical CollegeNew YorkNew York10021-
Monroe Biomedical ResearchMonroeNorth Carolina28112-
SPICA ClinicalColumbiaSouth Carolina29322-
Mt. Olympus Medical ResearchSugar LandTexas77479-

Related coverage on Hipa.ai

Find similar trials in Anniston, AL

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Pinnacle Research Group, LLC· Anniston, ALCullman Clinical Trials· Cullman, ALIndago Research & Health Center, Inc· Hialeah, FLClinical Neuroscience Solutions Inc· Jacksonville, FLAltus Research· Lake Worth, FLPennington Biomedical Research Center· Baton Rouge, LA

Related Studies