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NCT05933499 · ClinicalTrials.gov registry record · Phase 2
Effect of Tirzepatide and Bimagrumab on Body Composition, Insulin Sensitivity, and Bone in Adults With Obesity
A Phase 2 study of Obesity, sponsored by Massachusetts General Hospital.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 63
- Enrollment target
- 1
- Study location
NCT05933499: Recruiting Phase 2 study of Obesity, sponsored by Massachusetts General Hospital.
NCT05933499 is a Phase 2 study of Obesity that is actively recruiting participants, run by Massachusetts General Hospital. The registered enrollment target is 63 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05933499, a Phase 2 study of Obesity, is actively recruiting participants, sponsored by Massachusetts General Hospital.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 63 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Change in number of kilograms of lean mass by dual-energy x-ray absorptiometry in tirzepatide + bimagrumab vs. tirzepatide groups
Conditions Studied
Interventions
- DRUG Tirzepatide
- DRUG Bimagrumab
- DIETARY_SUPPLEMENT Calcium/Vitamin D
- BEHAVIORAL Lifestyle and nutrition counseling
Study Locations (1)
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2025-11-05 |
| Est. Completion | 2029-03-31 |
| Phase | Phase 2 |
What NCT05933499 shows while recruiting
NCT05933499 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 63 participants, a relatively small participant target, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (92% lower).
The record links to 1 condition, with Obesity appearing as the primary indexed condition, and to 4 interventions - of which Tirzepatide is the first listed.
NCT05933499 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT05933499 about?
NCT05933499 is a clinical study titled "Effect of Tirzepatide and Bimagrumab on Body Composition, Insulin Sensitivity, and Bone in Adults With Obesity". 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, redu...
What is the current status of trial NCT05933499?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 63 participants. The study started on 2025-11-05. Estimated completion is 2029-03-31.
What conditions does trial NCT05933499 study?
This clinical trial studies the following conditions: Obesity.
What interventions are being tested in trial NCT05933499?
The interventions under investigation include: Tirzepatide (DRUG), Bimagrumab (DRUG), Calcium/Vitamin D (DIETARY_SUPPLEMENT), Lifestyle and nutrition counseling (BEHAVIORAL).
Who is sponsoring clinical trial NCT05933499?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05933499 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Obesity
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05933499's enrollment target sits among peer trials
63 627th of 1053 higher than 423 of 1,053 other Obesity trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obesity trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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