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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: Recruiting Early Phase 1 study of Hypertrophic Cardiomyopathy Without Obstruction, sponsored by University of Pennsylvania.
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, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (51% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Adverse event reporting
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 |
What NCT06433050 shows while recruiting
NCT06433050 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (51% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT06433050's enrollment target sits among peer trials
26 977th of 2000 higher than 1,002 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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