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

Recruiting Phase 3 Interventional Study
Obstructive Cardiomyopathy, Hypertrophic Non-obstructive Hypertrophic Cardiomyopathy
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
500 (estimated)
Sponsor
Lexicon Pharmaceuticals · Industry
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About This Trial

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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * KCCQ CSS \< 85. * NYHA functional class II or III * A diagnosis of HCM consistent with the current American College of Cardiology Foundation/American Heart Association and European Society of Cardiology guideline definition: unexplained left ventricular (LV) hypertrophy with n…
Contacts

Tracy Newbold

281-863-3016

tnewbold@lexpharma.com

CONTACT