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NCT06433050 · ClinicalTrials.gov registry record · Early Phase 1
Sodium Glucose Co-transporter (SGLT) Inhibitors in Nonobstructive Hypertrophic Cardiomyopathy
A Early Phase 1 study of Hypertrophic Cardiomyopathy Without Obstruction, sponsored by University of Pennsylvania.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 26
- Enrollment target
- 1
- Study location
NCT06433050 is a Early Phase 1 study of Hypertrophic Cardiomyopathy Without Obstruction that is actively recruiting participants, run by University of Pennsylvania. The registered enrollment target is 26 participants. The trial reports 1 study location across 1 state.
The verdict
NCT06433050, a Early Phase 1 study of Hypertrophic Cardiomyopathy Without Obstruction, is actively recruiting participants, sponsored by University of Pennsylvania.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 26 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Conditions Studied
Interventions
- DRUG Sotagliflozin
Study Locations (1)
Pennsylvania
- University of Pennsylvania - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2024-12-17 |
| Est. Completion | 2027-06 |
| Phase | Early Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06433050
The ClinicalTrials.gov registry entry for NCT06433050 describes a study currently listed as recruiting, categorized as Early Phase 1. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pennsylvania, which has 1,423 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Hypertrophic Cardiomyopathy Without Obstruction appearing as the primary indexed condition, and to 1 intervention - of which Sotagliflozin is the first listed.
NCT06433050 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT06433050 about?
NCT06433050 is a clinical study titled "Sodium Glucose Co-transporter (SGLT) Inhibitors in Nonobstructive Hypertrophic Cardiomyopathy". 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 aim...
What is the current status of trial NCT06433050?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 26 participants. The study started on 2024-12-17. Estimated completion is 2027-06.
What conditions does trial NCT06433050 study?
This clinical trial studies the following conditions: Hypertrophic Cardiomyopathy Without Obstruction.
What interventions are being tested in trial NCT06433050?
The interventions under investigation include: Sotagliflozin (DRUG).
Who is sponsoring clinical trial NCT06433050?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06433050 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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