Sodium Glucose Co-transporter (SGLT) Inhibitors in Nonobstructive Hypertrophic Cardiomyopathy

Conditions

• Hypertrophic Cardiomyopathy Without Obstruction

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Sotagliflozin — DRUG
  Sotagliflozin or placebo will be administered to each participant in a cross over study design. Each participant will receive active drug and placebo with randomization of the order in which they receive them.

Study Details

The goal of this clinical trial is to learn if sotagliflozin, a dual SGLT1 and SGLT2 inhibitor, works to treat symptomatic, nonobstructive hypertrophic cardiomyopathy (noHCM) in adult patients. It will also learn about the safety of sotagliflozin in this patient population. The main questions it aims to answer are: 1. Will sotagliflozin be well tolerated in patients with nonobstructive HCM? 2. Will sotaglifozin improve exercise capacity, diastolic dysfunction and/or physical functioning in patients with nonobstructive HCM? 3. Will sotagliflozin improve circulating markers of cardiac metabolism in patients with nonobstructive HCM? Researchers will compare sotagliflozin to a placebo (a look-alike substance that contains no drug) to see if sotagliflozin is effective at treating hypertrophic cardiomyopathy (HCM). Participants will: Take sotagliflozin or a placebo every day for 12 weeks. They will then cross-over (or switch) to taking placebo or sotagliflozin (whichever one they did not take initially) for an additional 12 weeks. Visit the clinic once every 4-12 weeks for checkups, surveys, and tests including a stress test and echocardiogram.

Key Dates

Start date

Dec 17, 2024

Status verified

Feb 2026

Primary completion

Apr 30, 2027

Completion

Jun 30, 2027

Study Design

Enrollment

26 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Arms

• Placebo Comparator: Placebo first phase, Sotagliflozin second phase
  Matching placebo once daily will be administered in the first phase, Sotagliflozin 400 mg once daily will be administered in the second phase
• Active Comparator: Sotagliflozin first phase, Placebo second phase
  Sotagliflozin 400 mg once daily will be administered in the first phase, matching placebo once daily will be administered in the second phase

Primary Outcome Measure

Number of participants with treatment-related adverse events [ Time Frame: Through study completion, 28 weeks ]

Central Contacts

• Sharlene Day, MD
  734-548-0394
  [email protected]
• Kim Clinton
  215-431-4545
  [email protected]

Locations (1)

Find similar trials in Philadelphia, PA

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