A Study to Evaluate the Efficacy and Safety of Sotagliflozin in Symptomatic Obstructive and Non-obstructive Hypertrophic Cardiomyopathy
Condition(s) studied
Investigational drug(s) / intervention(s)
Sotagliflozin: Sotagliflozin will be administered as a tablet(s), orally once daily.
Placebo: Placebo will be administered as a tablet(s) (identical to the sotagliflozin tablet in appearance), orally once daily.
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.
Eligibility
Primary outcome measure(s)
- Change from Baseline to Week 26 in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ CSS) — Baseline to Week 26
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.
Trial sites (108)
| Facility | City | Region | Status |
|---|---|---|---|
| Lexicon Investigational Site (4041) | Phoenix | Arizona | |
| Lexicon Investigational Site (4037) | Scottsdale | Arizona | |
| Lexicon Investigational Site (4012) | Los Angeles | California | |
| Lexicon Investigational Site (4035) | Pomona | California | |
| Lexicon Investigational Site (4044) | San Francisco | California | |
| Lexicon Investigational Site (4046) | Jacksonville | Florida | |
| Lexicon Investigational Site (4034) | Orlando | Florida | |
| Lexicon Investigational Site (4018) | Atlanta | Georgia | |
| Lexicon Investigational Site (4033) | Evanston | Illinois | |
| Lexicon Investigational Site (4036) | Merrillville | Indiana | |
| Lexicon Investigational Site (4021) | Baltimore | Maryland | |
| Lexicon Investigational Site (4016) | Boston | Massachusetts | |
| Lexicon Investigational Site (4042) | Boston | Massachusetts | |
| Lexicon Investigational Site (4028) | Ann Arbor | Michigan | |
| Lexicon Investigational Site (4038) | Grand Rapids | Michigan | |
| Lexicon Investigational Site (4027) | Rochester | Minnesota | |
| Lexicon Investigational Site (4013) | St Louis | Missouri | |
| Lexicon Investigational Site (4029) | Morristown | New Jersey | |
| Lexicon Investigational Site (4039) | Manhasset | New York | |
| Lexicon Investigational Site (4043) | New York | New York | |
| Lexicon Investigational Site (4026) | Morrisville | North Carolina | |
| Lexicon Investigational Site (4031) | Cincinnati | Ohio | |
| Lexicon Investigational Site (4017) | Cleveland | Ohio | |
| Lexicon Investigational Site (4024) | Tulsa | Oklahoma | |
| Lexicon Investigational Site (4015) | Portland | Oregon | |
| Lexicon Investigational Site (4011) | Philadelphia | Pennsylvania | |
| Lexicon Investigational Site (4019) | Germantown | Tennessee | |
| Lexicon Investigational Stie (4014) | Houston | Texas | |
| Lexicon Investigational Site (4032) | Charlottesville | Virginia | |
| Lexicon Investigational Site (4045) | Seattle | Washington | |
| Lexicon Investigational Site (4010) | Seattle | Washington | |
| Lexicon Investigational Site (4022) | Marshfield | Wisconsin | |
| Lexicon Investigational Site (4040) | Milwaukee | Wisconsin | |
| Lexicon Investigational Site (5016) | Santa Rosa | La Pampa Province | |
| Lexicon Investigational Site (5012) | Rosario | Santa Fe Province | |
| Lexicon Investigational Site (5014) | Santa Fe | Santa Fe Province | |
| Lexicon Investigational Site (5015) | Corrientes | Argentina | |
| Lexicon Investigational Site (5010) | Córdoba | Argentina | |
| Lexicon Investigational Site (5013) | Córdoba | Argentina | |
| Lexicon Investigational Site (5011) | Salta | Argentina |
+ 68 more sites — see the full list on the official registry below.
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06481891 on ClinicalTrials.gov ↗ ← All trials in Italy