DelfaGLP-1 Atlas

← Trials/Trial dossier/NCT07642635

Not yet recruitingPhase 1, PHASE2

Glucagon-Like Peptide-1 Receptor Agonists to Attenuate Metabolic Risk in Individuals With Duchenne Muscular Dystrophy

Asset

Semaglutide

Oral · GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

30

estimated

Study population

Obesity / overweight, Sarcopenia / muscle

Key I/E criteria

•BMI ≥30•Male

Primary endpoint

•Muscle Volume Index (MVI)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07642635
Org study ID260611

Timeline

Milestones

Study first posted2026-06-11actual
Last update posted2026-06-11actual
Study start2026-09-01estimated
Primary completion2030-09estimated (month precision)
Study completion2030-12estimated (month precision)

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Obesity / overweightSarcopenia / muscle

Eligibility

Who can enroll

Minimum age18 Years
SexMale
Healthy volunteersNot accepted

Inclusion criteria

•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 criteria

•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

Endpoints (7)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)
3
Weight & body composition
2
Glycemic / diabetes
1
Heart failure
1

Weight & body composition

2 endpoints
Secondary/protocol endpoint

Visceral adiposity

Time frame:Week 0 (baseline), week 24 (end of RCT), week 64 (end of study)

descriptive

Secondary/protocol endpoint

Weight

Time frame:Week 0 (baseline), week 24 (end of RCT), week 64 (end of study)

descriptive

Glycemic / diabetes

1 endpoint
Secondary/protocol endpoint

Insulin sensitivity

Time frame:Week 0 (baseline), week 24 (end of RCT), week 64 (end of study)

descriptive

Heart failure

1 endpoint
Secondary/protocol endpoint

LVEF

Time frame:Week 0 (baseline) and week 64 (end of study)

descriptive

Other (unclassified)

3 endpoints
Primary/protocol endpoint/low confidence

Muscle Volume Index (MVI)

Time frame:Week 0 (baseline), week 24 (end of RCT), week 64 (end of study)

descriptive

Secondary/protocol endpoint/low confidence

Late gadolinium enhancement (LGE)

Time frame:Week 0 (baseline) and week 64 (end of study).

descriptive

Secondary/protocol endpoint/low confidence

FVC%

Time frame:Week 0 (baseline) and week 64 (end of study).

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.