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Clinical Trials in the UK / NCT06481891
Active, not recruiting Phase 3

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

NCT06481891 · tracked via the Priya Life Science UK tracker
Sponsor
Lexicon Pharmaceuticals
Phase
Phase 3
Started
2024-09-24
Last updated
2026-08-26

Condition(s) studied

Obstructive Cardiomyopathy, HypertrophicNon-obstructive Hypertrophic Cardiomyopathy

Investigational drug(s) / intervention(s)

SotagliflozinPlacebo

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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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 nondilated ventricular chambers in the absence of other cardiac (eg, hypertension, aortic stenosis) or systemic disease with maximal LV wall thickness ≥ 15 millimeters (mm), or ≥ 13 mm with positive family history of HCM. * For obstructive hypertrophic cardiomyopathy (oHCM), left ventricular outflow tract (LVOT) peak gradient ≥ 30 millimetre of mercury (mm Hg) during screening as assessed by echocardiography at rest or during a valsalva maneuver. * For nonobstructive hypertrophic cardiomyopathy (nHCM), LVOT peak gradient \< 30 mm Hg during screening as assessed by echocardiography at rest and \< 30 mm Hg during a valsalva maneuver. * Screening left ventricular ejection fraction (LVEF) ≥ 50%, except for those on a cardiac myosin inhibitor (screening LVEF ≥ 55%). * For participants on a cardiac myosin inhibitor, the dose must be stable at least 3 months prior to screening. Participants on cardiac myosin inhibitor should not be scheduled for up-titration during the trial. * Stable doses of background therapy (ie, β-blockers, calcium channel blockers, angiotensin-converting enzyme (ACE) inhibitors, angiotensin receptor blockers, diuretics) for at least 1 month prior to screening. Exclusion Criteria: * Received therapy with a sodium glucose co-transporter 2 (SGLT2) inhibitor within the past 8 weeks prior to screening. * Previous intolerance to an SGLT2 inhibitor. * Any previous treatment with sotagliflozin. * Current use of thiazolidinediones or digoxin. * Current/planned participation in another interventional clinical trial or prior participation in any interventional trial with an investigational agent within 45 days of screening. * Known infiltrative or storage disorder causing cardiac hypertrophy that mimics HCM such as Fabry disease, amyloidosis, or Noonan syndrome with LV hypertrophy. * History of unexplained syncope within 6 months prior to screening. * History of sustained ventricular tachyarrhythmia (\> 30 seconds) or appropriate implantable cardioverter defibrillator (ICD) discharge within 6 months prior to screening. * Has paroxysmal, persistent, or permanent atrial fibrillation not on anticoagulation for at least 4 weeks prior to screening and/or not adequately rate controlled within 3 months of screening. * Septal reduction therapy planned during the study period. For participants who had septal reduction therapy, the procedure should have been completed more than 3 months prior to screening. * Cardiac surgery (eg, coronary artery bypass graft, valvular repair/replacement), percutaneous coronary intervention, or implantation of cardiac device (pacemaker or implantable cardioverter defibrillator) within 3 months prior to screening or planned during the study period. * Presence of a cardiac resynchronization therapy device. * Acute coronary syndrome within 2 months prior to screening. * History of stroke or myocardial infarction within 6 months prior to screening. * Hospitalization for heart failure or arrhythmia within 4 weeks prior to screening. * Has known moderate or severe (as per investigator's judgment) aortic valve stenosis at screening. * Current angina or clinically significant ischemia due to unstable epicardial coronary disease, as per investigator judgment.

Primary outcome measure(s)

Trial sites (108)

FacilityCityRegionStatus
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

Official registry record

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 the UK