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

Conditions

• Obese
• Obesity
• Overweight or Obesity

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

First listed

Nov 14, 2022

Start date

Nov 16, 2022

Status verified

Jun 2026

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/30 mg/kg Bimagrumab
  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.
• Experimental: 10/30 mg/kg Bimagrumab
  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.
• Experimental: 30 mg/kg Bimagrumab
  Participants received intravenous 30 mg/kg bimagrumab at baseline and at Weeks 4, 16, 28, 40, 52, and 64.
• Experimental: Placebo + 1.0 mg Semaglutide
  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
• Experimental: Placebo + 2.4 mg Semaglutide
  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
• Experimental: 10 mg/kg Bimagrumab + 1.0 mg Semaglutide
  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
• Experimental: 10 mg/kg Bimagrumab + 2.4 mg Semaglutide
  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
• Experimental: 30 mg/kg Bimagrumab + 1.0 mg Semaglutide
  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
• Experimental: 30 mg/kg Bimagrumab + 2.4 mg Semaglutide
  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

Primary Outcome Measure

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

Locations (10)

Related coverage on Hipa.ai

• Semaglutide with Bimagrumab Shows Enhanced Weight Loss in Obesity
  Semaglutide · Jul 18, 2025 · ClinicalTrials.gov

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