NCT06481891Phase 3Active not recruiting

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

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2027-01Estimated

Enrollment · participants500Estimated

Source updated2026-08-26Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Posted 2026-08-26 · 1 field changed

Primary completion date changed

− Before

~~Jul 2026~~

+ After

Jan 2027

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Posted 2026-07-29 · 1 field changed

Recruitment status changed

− Before

~~Recruiting~~

+ After

Active not recruiting

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Study details

Conditions studied

Obstructive Cardiomyopathy, Hypertrophic; Non-obstructive Hypertrophic Cardiomyopathy

Treatments or interventions studied

SotagliflozinDrugAlso known as SAR439954/LX4211
PlaceboDrugAlso known as SAR439954/LX4211

Primary outcomes · main study measures

Read the study measures

measure: Change from Baseline to Week 26 in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ CSS); description: KCCQ is a 23-item, self-administered questionnaire that measure the participant's perception of their health status, including their heart failure (HF) symptoms, impact on physical and social function and how their HF impacts the quality of life. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores are generated for each domain and scaled from 0 to 100, with 0 denoting the worst and 100 the best possible status. Higher scores reflect better health status.; timeFrame: Baseline to Week 26

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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