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

NCT06481891 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2026-05-18

No results posted yet for this study

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

  • Obstructive Cardiomyopathy, Hypertrophic
  • Non-obstructive Hypertrophic Cardiomyopathy

Interventions

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.

Sponsors & Collaborators

  • Lexicon Pharmaceuticals

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-24
Primary Completion
2026-07-31
Completion
2026-08-31
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Belgium
  • Brazil
  • Bulgaria
  • Croatia
  • Czechia
  • France
  • Georgia
  • Germany
  • Hungary
  • Israel
  • Italy
  • Poland
  • Portugal
  • Romania
  • Serbia
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06481891 on ClinicalTrials.gov