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A Study to Evaluate the Efficacy and Safety of Sotagliflozin in Symptomatic Obstructive and Non-obstructive Hypertrophic Cardiomyopathy
NCT06481891 · View on ClinicalTrials.gov ↗
Study Summary
The main purpose of the study is to determine the changes in symptoms and functional limitations in participants with symptomatic hypertrophic cardiomyopathy (HCM) treated with sotagliflozin as compared to placebo.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Sotagliflozin
Study Locations (20)
California
- Lexicon Investigational Site (4012) — Los Angeles
- Lexicon Investigational Site (4035) — Pomona
- Lexicon Investigational Site (4044) — San Francisco
Arizona
- Lexicon Investigational Site (4041) — Phoenix
- Lexicon Investigational Site (4037) — Scottsdale
Florida
- Lexicon Investigational Site (4046) — Jacksonville
- Lexicon Investigational Site (4034) — Orlando
Massachusetts
- Lexicon Investigational Site (4016) — Boston
- Lexicon Investigational Site (4042) — Boston
Michigan
- Lexicon Investigational Site (4028) — Ann Arbor
- Lexicon Investigational Site (4038) — Grand Rapids
New York
- Lexicon Investigational Site (4039) — Manhasset
- Lexicon Investigational Site (4043) — New York
Georgia
- Lexicon Investigational Site (4018) — Atlanta
Illinois
- Lexicon Investigational Site (4033) — Evanston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Start Date | 2024-09-24 |
| Est. Completion | 2026-08 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06481891
The ClinicalTrials.gov registry entry for NCT06481891 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 500 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Lexicon Pharmaceuticals, which has 12 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Non-obstructive Hypertrophic Cardiomyopathy appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06481891 reports 20 study locations spanning 13 distinct geographic areas — top geographies include California, Arizona, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06481891 about?
NCT06481891 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of Sotagliflozin in Symptomatic Obstructive and Non-obstructive Hypertrophic Cardiomyopathy". The main purpose of the study is to determine the changes in symptoms and functional limitations in participants with symptomatic hypertrophic cardiomyopathy (HCM) treated with sotagliflozin as compared to placebo.
What is the current status of trial NCT06481891?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 500 participants. The study started on 2024-09-24. Estimated completion is 2026-08.
What conditions does trial NCT06481891 study?
This clinical trial studies the following conditions: Non-obstructive Hypertrophic Cardiomyopathy, Obstructive Cardiomyopathy, Hypertrophic. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06481891?
The interventions under investigation include: Placebo (DRUG), Sotagliflozin (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06481891?
This trial is sponsored by Lexicon Pharmaceuticals, which has 12 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06481891 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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