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NCT07642635 · ClinicalTrials.gov registry record · Phase 1
Glucagon-Like Peptide-1 Receptor Agonists to Attenuate Metabolic Risk in Individuals With Duchenne Muscular Dystrophy
A Phase 1 study, sponsored by Vanderbilt University Medical Center.
- Not yet
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT07642635 is a Phase 1 study that has not yet begun recruiting, run by Vanderbilt University Medical Center. The registered enrollment target is 30 participants.
The verdict
NCT07642635, a Phase 1 study, has not yet begun recruiting, sponsored by Vanderbilt University Medical Center.
- NOT YET RECRUITING
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
Duchenne Muscular Dystrophy (DMD) is a rare, genetic disease that leads to muscle weakness, breathing difficulties, heart disease, and early death. Approximately half of individuals with DMD have elevated body mass indices (BMIs) in the overweight or obesity range. High BMI is due to a combination of factors including limited mobility and steroid medications, which are used to treat DMD. There are new medications, glucagon-like peptide-1 receptor agonists (GLP-1 RAs) that promote weight loss in the general population. GLP-1 RAs are approved for weight loss in children and adults and have beneficial effects on the heart. There is a concern that these medications could have unwanted side effects in individuals with DMD, specifically decreasing their muscle mass. While it is important to consider the use weight-loss medications in DMD, the investigators want to ensure that they are safe and well-tolerated. Therefore, this study will systematically evaluate whether the use of GLP-1 RAs in adolescents and young adults with DMD affects muscle mass. The overall goal of this study is to assess the safety and tolerability of GLP1-RAs in individuals with both DMD and obesity. The primary focus will be on muscle health, but the study will also evaluate activity levels, mood, gastrointestinal symptoms, and quality of life. Secondary goals will be to understand the impact of GLP1-RAs on weight, fat mass, glucose and insulin levels, and heart and lung function in individuals with DMD. The investigators hypothesize that GLP1-RAs will be well-tolerated and will decrease fat mass, without a large decrease in muscle mass. Participants will: * Take oral semaglutide or a placebo every day for 24 weeks (randomized controlled trial) * Then take oral semaglutide every day for 40 weeks (open label extension) * Complete in-person study visits at 3 timepoints * Study visits may include: an MRI of the body to evaluate muscle and fat tissue, laboratory testing, a mixed meal tolerance test,
Interventions
- OTHER Placebo
- DRUG Semaglutide (Rybelsus®)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2026-09-01 |
| Est. Completion | 2030-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07642635
The ClinicalTrials.gov registry entry for NCT07642635 describes a study currently listed as not yet recruiting, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vanderbilt University Medical Center, which has 677 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT07642635 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07642635 about?
NCT07642635 is a clinical study titled "Glucagon-Like Peptide-1 Receptor Agonists to Attenuate Metabolic Risk in Individuals With Duchenne Muscular Dystrophy". Duchenne Muscular Dystrophy (DMD) is a rare, genetic disease that leads to muscle weakness, breathing difficulties, heart disease, and early death. Approximately half of individuals with DMD have elevated body mass indices (BMIs) in the overweight or obesity range. High BMI is due to a combination o...
What is the current status of trial NCT07642635?
This trial is currently not yet recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2026-09-01. Estimated completion is 2030-12.
What interventions are being tested in trial NCT07642635?
The interventions under investigation include: Placebo (OTHER), Semaglutide (Rybelsus®) (DRUG).
Who is sponsoring clinical trial NCT07642635?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
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