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

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NCT06481891

Sponsored by Lexicon Pharmaceuticals (industry) · LXRX — their whole pipeline →.

Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
500estimated
Sites
108
Countries
Argentina, Belgium, Brazil +16

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis
DateFiledBasisWhat it is
Start2024-09-24actualWhen the study began enrolling
Primary completionJul 2026estimatedThe date the last participant is measured for the primary outcome — the readout window
Study completionAug 2026estimatedThe whole study's end, after follow-up
First posted2024-07-01actualWhen this record first appeared on the registry
Results postedWhen the sponsor posted results to the registry
Record updated2026-07-29actualThe sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Conditions

  • Obstructive Cardiomyopathy, Hypertrophic
  • Non-obstructive Hypertrophic Cardiomyopathy

Interventions

  • Drug: Sotagliflozin — also filed as SAR439954/LX4211
  • Drug: Placebo — also filed as SAR439954/LX4211

Primary outcome

what the primary-completion date above is the date OF
Change from Baseline to Week 26 in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ CSS)
measured Baseline to Week 26

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