Trials / Recruiting
RecruitingNCT06481891
A Study to Evaluate the Efficacy and Safety of Sotagliflozin in Symptomatic Obstructive and Non-obstructive Hypertrophic Cardiomyopathy
A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of SOtaglifloziN in symptomATic Obstructive And Non-obstructive Hypertrophic CardioMyopathy (SONATA-HCM)
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 500 (estimated)
- Sponsor
- Lexicon Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Sotagliflozin | Sotagliflozin will be administered as a tablet(s), orally once daily. |
| DRUG | Placebo | Placebo will be administered as a tablet(s) (identical to the sotagliflozin tablet in appearance), orally once daily. |
Timeline
- Start date
- 2024-09-24
- Primary completion
- 2026-07-01
- Completion
- 2026-08-01
- First posted
- 2024-07-01
- Last updated
- 2026-02-27
Locations
107 sites across 19 countries: United States, Argentina, Belgium, Brazil, Bulgaria, Croatia, Czechia, France, Georgia, Germany, Hungary, Israel, Italy, Poland, Portugal, Romania, Serbia, Sweden, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06481891. Inclusion in this directory is not an endorsement.