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

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement, Drug, Behavioral
Study Type: Interventional
Study Phase: Phase 2
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 may have negative effects on health by lessening improvements in glucose and insulin levels, reducing resting 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 help maximize loss of fat mass while maintaining muscle mass when used in combination with a glucagon-like peptide 1 receptor agonist (GLP-1 RA). The investigators hypothesize that in a randomized, placebo-controlled trial of 63 adults with obesity randomized to tirzepatide (GLP-1/GIP RA) + bimagrumab, tirzepatide alone, or bimagrumab alone, the combination of tirzepatide + bimagrumab will result in improvements in muscle, fat, and bone compared to tirzepatide alone or bimagrumab alone when given in addition to a lifestyle intervention for weight loss over 52 weeks.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• BMI ≥30 kg/m2 or ≥27kg/m2 with at least one weight-related medical condition

• Have a history of at least one self-reported unsuccessful behavioral effort to lose body weight

• Have an established primary care provider

Locations
United States
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
Contact Information
Primary
Melanie S Haines, MD
mshaines@mgh.harvard.edu
617-726-3870
Time Frame
Start Date: 2025-11-05
Estimated Completion Date: 2029-03-31
Participants
Target number of participants: 63
Treatments
Experimental: Tirzepatide + bimagrumab
Active_comparator: Tirzepatide + placebo
Active_comparator: Bimagrumab + placebo
Related Therapeutic Areas
Sponsors
Leads: Massachusetts General Hospital

This content was sourced from clinicaltrials.gov