A Study to Evaluate the Efficacy and Safety of Sotagliflozin in Symptomatic Obstructive and Non-obstructive Hypertrophic Cardiomyopathy
Part of paid clinical trials in Phoenix, Arizona.
- Sponsor
- Lexicon Pharmaceuticals
- Study ID
- NCT06481891
- Phase
- PHASE3
- Status
- Recruiting
Conditions
- Non-obstructive Hypertrophic Cardiomyopathy
- Obstructive Cardiomyopathy, Hypertrophic
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Sotagliflozin — DRUGSotagliflozin will be administered as a tablet(s), orally once daily.
- Placebo — DRUGPlacebo will be administered as a tablet(s) (identical to the sotagliflozin tablet in appearance), orally once daily.
Study Details
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.
Key Dates
- Start date
- Sep 24, 2024
- Status verified
- May 2026
- Primary completion
- Jul 31, 2026
- Completion
- Aug 31, 2026
Study Design
- Enrollment
- 500 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: SotagliflozinFollowing an up to 3-week screening period, sotagliflozin 400 milligrams (mg) tablets will be administered as two 200 mg tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 26 weeks.
- Placebo Comparator: PlaceboFollowing an up to 3-week screening period, sotagliflozin-matching placebo 400 mg tablets will be administered as two 200 mg tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 26 weeks.
Primary Outcome Measure
Change from Baseline to Week 26 in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ CSS) [ Time Frame: Baseline to Week 26 ]
Central Contacts
- Tracy Newbold281-863-3016
Locations (33)
Find similar trials in Phoenix, AZ
By research site
Lexicon Investigational Site (4041)· Phoenix, AZLexicon Investigational Site (4037)· Scottsdale, AZLexicon Investigational Site (4012)· Los Angeles, CALexicon Investigational Site (4035)· Pomona, CALexicon Investigational Site (4044)· San Francisco, CALexicon Investigational Site (4046)· Jacksonville, FL
Related Studies
- A Trial to Evaluate the Efficacy and Safety of Ninerafaxstat in Patients With Symptomatic Non-obstructive Hypertrophic CardiomyopathyPHASE2 · Recruiting · Imbria Pharmaceuticals, Inc. · La Jolla, California