NCT05616013

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

A Randomized, Double-Blind, Placebo-Controlled Multi-Center Study of Intravenous Bimagrumab, Alone or in Addition to Open Label Subcutaneous Semaglutide, to Investigate the Efficacy and Safety in Overweight or Obese Men and Women

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 507 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

This study investigates if bimagrumab in addition to semaglutide is able to preserve/increase muscle mass in the presence of weight and/or fat mass loss.

Conditions

• Obesity
• Obese
• Overweight or Obesity

Interventions

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

Timeline

• Start date: 2022-11-16
• Primary completion: 2024-05-16
• Completion: 2025-06-14
• First posted: 2022-11-14
• Last updated: 2025-07-18
• Results posted: 2025-07-18

Locations

26 sites across 3 countries: United States, Australia, New Zealand

Regulatory

• FDA-regulated drug study