NCT07642635
Glucagon-Like Peptide-1 Receptor Agonists to Attenuate Metabolic Risk in Individuals With Duchenne Muscular Dystrophy
Not Yet Recruiting
PHASE1Ages 18+InterventionalTreatmentVanderbilt University Medical CenterInvestigator-initiated
~30 participants
Updated 2026-06-11 on ClinicalTrials.gov
What's tested:Semaglutide (Rybelsus®)Placebo
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Muscle Volume Index (MVI)
Measured over Week 0 (baseline), week 24 (end of RCT), week 64 (end of study)
Conditions
Where it's being run
1 sites across 1 statesTennessee1
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
Male
Age ≥18years
BMI ≥ 30kg/m2 or BMI ≥ 27kg/m2 with at least one weight-related comorbid condition (e.g., hypertension, T2D, or dyslipidemia).
Clinical phenotype of DMD confirmed with muscle biopsy or genotype
Exclusion
Type 1 diabetes, uncontrolled type 2 diabetes (HbA1c \>8%) or type 2 diabetes requiring the use of insulin or sulfonylurea.
History of pancreatitis
Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2
History of allergic reaction to semaglutide or medication components
Contraindication to MRI. If unable to tolerate whole body/cardiac MRI but able to undergo lower extremity MRI, the participant may be invited to complete extremity MRI (Aim 1) and not complete MRI for Aim 2/3 (secondary Aims/outcomes)
Uncontrolled major depressive disorder, lifetime history of suicide attempt, history of other severe psychiatric disorders (e.g., schizophrenia, bipolar disorder), PHQ-9 score ≥15 or suicidal ideation type 4 or 5 (C-SSRS)
Unable to comply with study procedures or unsafe to complete the study in the opinion of the investigator
What this trial measures
- Muscle Volume Index (MVI)Week 0 (baseline), week 24 (end of RCT), week 64 (end of study)
Assessment of muscle mass via skeletal muscle MRI. Change in MVI from baseline to week 24 will be compared in those on placebo compared to those on semaglutide.