Sodium/Glucose Cotransporter-2 Inhibitors (SGLT2i) Therapy in Duchenne Cardiomyopathy

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Larry W. Markham
Study ID
NCT07172971
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Duchenne Muscular Dystrophy (DMD)

Eligibility Criteria

Sex
MALE
Age
8 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • SGLT-2 inhibitor — DRUG
    SGLT-2 inhibitor will be given once daily by mouth
  • SGLT2 inhibitor — DRUG
    SGLT-2 inhibitor will be given once daily by mouth

Study Details

This is a pharmacokinetic study (PK Study) to better understand empagliflozin dosing in pediatric Duchenne muscular dystrophy patients. Empagliflozin is currently used off-label in this population due to the mortality benefits seen in adult cardiomyopathy and heart failure. Investigators will perform PK studies in DMD patients of various ages and weights to better understand the PK profile (absorption, distribution, metabolism, excretion) and dosing to better treat Duchenne cardiomyopathy.

Key Dates

Start date
Feb 1, 2026
Status verified
Dec 2025
Primary completion
Aug 1, 2027
Completion
Feb 1, 2028

Study Design

Enrollment
10 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Dosing
    At the initial stage, investigators will allocate 3 subjects to 5 mg and 3 subjects 10 mg depending on their body weight (i.e., 5 mg for children with weight les than 40 kg, 10 mg for those with greater than 40 kg).
  • Experimental: Pharmacokinetics
    In the second stage, based on the Pharmacokinetics (PK) analysis results from the initial 6 subjects divided in 5 mg and 10 mg dose groups, the next dose will be determined, for which the remaining 4 subjects will be allocated. The next dose decision will be made based on the target drug concentration levels along with the estimated PK parameters (e.g., the area under the drug concentration time curve and the maximum concentration), which correspond to adults PK and drug levels.

Primary Outcome Measure

Medication dose [ Time Frame: From enrollment to 12 month analysis ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Riley Hospital at Indiana University HealthIndianapolisIndiana46202-

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By research site
Riley Hospital at Indiana University Health· Indianapolis, IN

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