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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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05933499
The ClinicalTrials.gov registry entry for NCT05933499 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 63 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (92% lower). The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Related
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