A Phase 3 interventional study of Sotagliflozin and Placebo in Obstructive Cardiomyopathy, Hypertrophic and Non-obstructive Hypertrophic Cardiomyopathy, sponsored by Lexicon Pharmaceuticals. Active, not recruiting at 108 sites in 19 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-26.
Sponsored by Lexicon Pharmaceuticals · Phase 3, Interventional, and Treatment
Among 125 studies in Cardiomyopathy, Hypertrophic with a site in United States — 23 open to participants now, 37 under way, 6 of them phase 3. Cardiomyopathy, Hypertrophic · United States.
Among the 125 studies in Cardiomyopathy, Hypertrophic with a site in United States, this one is the 4th largest by planned enrollment of the 65 interventional ones that give a count, is one of 10 that started in 2024, is one of 9 in phase 3, reaches primary completion later than 14 of the 36 other live ones, and was the 106th registered.
363 studies on the registry are indexed under Cardiomyopathy, Hypertrophic; 116 are open to participants now.
Browse Cardiomyopathy, Hypertrophic studies →23 of the 125 studies in Cardiomyopathy, Hypertrophic with a site in United States are open now. Recruiting first, the newest first:
Haya Therapeutics, Inc. · Sites in United States
Braveheart Bio, Inc. · Sites in United States
Christopher Kramer · Sites in United States, United Kingdom
Lexeo Therapeutics · Sites in United States
Oregon Health and Science University · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 81 Cardiomyopathy, Hypertrophic studies recruiting now, 55 (68%) set no upper age limit and 8 (10%) stop at 75 or younger; 21 take children under 18; 13 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
125 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 11 · Phase 2 27 · Phase 3 14 · Phase 4 5
First in 1987; this study’s year is marked. 10 started in 2024.
This study's planned enrollment of 500 is above the median of 60 across 180 interventional studies indexed under Cardiomyopathy, Hypertrophic.
Median enrollment 50 across the 65 interventional studies, 150 across the 58 observational. Of the 80 that completed or were terminated, 25 (31%) have results posted.
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49 of 125 have an industry lead sponsor. The 10 most frequent:
Lexicon Pharmaceuticals is the lead sponsor of 61 studies on the registry; none are open to participants now.
Of its 18 completed or terminated interventional studies of FDA-regulated products, 15 (83%) have results posted.
Lexicon Pharmaceuticals has 1 study filed under Cardiomyopathy, Hypertrophic — fewer than ten, so there is no comparison to draw.
10 of the studies in Cardiomyopathy, Hypertrophic with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06481891Phase 3Lexicon PharmaceuticalsA Study to Evaluate the Efficacy and Safety of Sotagliflozin in Symptomatic Obstructive and Non-obstructive Hypertrophic Cardiomyopathy | 2027-01 |
| NCT07023614Imbria Pharmaceuticals, Inc.A Trial to Evaluate the Efficacy and Safety of Ninerafaxstat in Patients With Symptomatic Non-obstructive Hypertrophic Cardiomyopathy | 2026-12 |
| NCT07600177Oregon Health and Science UniversityMavacamten to Aficamten Transition in Patients With Obstructive Hypertrophic Cardiomyopathy | 2026-12-31 |
| NCT06551129Bristol-Myers SquibbReal-world Patient Reported Outcomes Among Patients Treated With Camzyos | 2026-12-31 |
| NCT07867288Haya Therapeutics, Inc.Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HTX-001 | 2027-03 |
Among the 125 studies in Cardiomyopathy, Hypertrophic with a site in United States, from their registry updates:
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Following 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.
Drug: Sotagliflozin
Following 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.
Drug: Placebo
Sotagliflozin will be administered as a tablet(s), orally once daily.
Also known as: SAR439954/LX4211
Placebo will be administered as a tablet(s) (identical to the sotagliflozin tablet in appearance), orally once daily.
Also known as: SAR439954/LX4211
Change from Baseline to Week 26 in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ CSS)
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.
Time frame: Baseline to Week 26
Percentage of Participants at Week 26 with a New York Heart Association (NYHA) Functional Class Improvement ≥ 1 Category
NYHA functional class is a clinician-reported assessment of participants' health status on a 4-point scale, where Class I represents no limitations in normal activity; Class II indicates slight limitation of physical activity; Class III indicates marked limitation in physical activity; and Class IV indicates that participants have symptoms with any physical activity or at rest. Percentage of participants with NYHA functional class improvement ≥1 will be reported.
Time frame: Week 26
Change from Baseline to Week 26 in KCCQ Total Symptom Score (TSS).
KCCQ is a 23-item, self-administered questionnaire that measure the participant's perception of their health status, including their 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.
Time frame: Baseline to Week 26
Showing the first 100 of 108 sites across 19 countries. Choose a country and city above to see the rest.
Plan to share: No
No publications or documents are linked to this record.
Started Sep 2024 (actual). Primary completion is estimated for Jan 2027, 28 months after the start.
Of 15 phase 3 interventional studies under Cardiomyopathy, Hypertrophic, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 36. This study's planned 28 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Sotagliflozin
Cardiomyopathy, Hypertrophic →