drugset / Trial / NCT07172971
Sodium/Glucose Cotransporter-2 Inhibitors (SGLT2i) Therapy in Duchenne Cardiomyopathy
Phase 1
Recruiting
10 enrolled
Larry W. Markham
National Heart, Lung, and Blood Institute (NHLBI) · collab
RandomizedParallel-groupOpen-labelOther
Summary
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.
Timeline
- Start
- 2026-07-01
- Primary completion
- 2027-08-01
- Completion
- 2028-02-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Empagliflozin | Small molecule | 5 mg | Oral |
| Subject | Empagliflozin | Small molecule | 10 mg | Oral |