Effect of Bimagrumab on Body Composition, Insulin Sensitivity, and Bone in Adults With Obesity

Obesity Clinical Trial

Official title: Effect of Bimagrumab on Body Composition, Insulin Sensitivity, and Bone in Adults With Obesity

Status Not yet recruiting

Clinical Trial Summary

In adults with obesity seeking treatment, weight loss would ideally be composed almost exclusively of fat mass. However, loss of muscle mass and bone are unintentional consequences of weight loss, which has detrimental effects on health by lessening improvements in glucose and insulin levels, contributing to weight regain by reducing basal metabolic rate, and increasing the risk of falls, and fractures. Data in animals and humans suggest that bimagrumab, an investigational new drug for obesity that inhibits the activin type II receptor (ActRII) inhibitor, may build muscle and bone while resulting in a loss of fat mass. Semaglutide, which is FDA-approved for the treatment of obesity, results in loss of fat mass, but its effects on muscle and bone are less clear. The investigators hypothesize that in a randomized, placebo-controlled trial of 65 adults with obesity randomized to IV bimagrumab, identical IV placebo plus semaglutide, or identical IV placebo alone, bimagrumab will result in improvements in muscle, fat, and bone compared to semaglutide or placebo when given in addition to a lifestyle intervention for weight loss over 52 weeks.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Insulin Resistance
• Obesity

• NCT number: NCT05933499
• Study type: Interventional
• Source: Massachusetts General Hospital
• Contact: Melanie S Haines, MD
• Phone: 617-726-3870
• Email: mshaines@mgh.harvard.edu
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: July 1, 2024
• Completion date: August 1, 2028