RecruitingPhase 2NCT05933499

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


Sponsor

Massachusetts General Hospital

Enrollment

63 participants

Start Date

Nov 5, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Bimagrumab, Calcium/Vitamin D, and others for people with obesity. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBimagrumab

SQ bimagrumab 300mg qweek

DRUGTirzepatide

SQ tirzepatide 15mg qweek

DIETARY_SUPPLEMENTCalcium/Vitamin D

Elemental calcium 1200 mg + vitamin D3 800 IU PO daily

BEHAVIORALLifestyle and nutrition counseling

Lifestyle and nutrition counseling consistent with current guidelines for weight management


Locations(1)

Massachusetts General Hospital

Boston, Massachusetts, United States

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NCT05933499


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