Phase 3Active, not recruiting
A Study to Evaluate the Efficacy and Safety of Sotagliflozin in Symptomatic Obstructive and Non-obstructive Hypertrophic Cardiomyopathy (SONATA-HCM)
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)
- Sponsor
- Lexicon Pharmaceuticals (Industry)
- Enrollment
- 500 planned
- Conditions
- Obstructive Cardiomyopathy, Hypertrophic; Non-obstructive Hypertrophic Cardiomyopathy
- Interventions
- Sotagliflozin; Placebo
- Ages
- adults, older adults
- Registry
- NCT06481891
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Change from Baseline to Week 26 in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ CSS)
History
Study completion expected
Primary completion expected
Last registry update
Started
Registered