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NCT06481891 · ClinicalTrials.gov record · last posted 2026-08-26

A Study to Evaluate the Efficacy and Safety of Sotagliflozin in Symptomatic Obstructive and Non-obstructive Hypertrophic Cardiomyopathy

Study acronym: SONATA-HCM
StatusActive, Not Recruiting
PhasePhase 3
Started2024-09-24
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from the ClinicalTrials.gov record
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.

Protocol amendment history 3 changes detected by DataLookout

2026-08-27
Primary completion pushed: 2026-07 → 2027-01
2026-08-27
Completion pushed: 2026-08 → 2027-02
2026-07-30
Enrollment closed, study ongoing
Trial Details
NCT Number NCT06481891
Lead Sponsor Lexicon Pharmaceuticals
Conditions Obstructive Cardiomyopathy, Hypertrophic, Non-obstructive Hypertrophic Cardiomyopathy
Enrollment 500 participants
Start Date 2024-09-24
Primary Completion 2027-01 (estimated)
Study Completion 2027-02 (estimated)
Updated on ClinicalTrials.gov 2026-08-26