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ACTIVE NOT RECRUITINGPhase3

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

Sponsor: Lexicon Pharmaceuticals

NCT ID: NCT06481891

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Sotagliflozin (drug), Placebo (drug)
How long the study runs
Study runs about 29 months (dates as stated)
About the drug or intervention
Sotagliflozin — drug: Sotagliflozin will be administered as a tablet(s), orally once daily. · Placebo — drug: Placebo will be administered as a tablet(s) (identical to the sotagliflozin tablet in appearance), orally once daily.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
500
Started
2024-09-24
Last checked
2026-08

Plain English Summary

What is this study?

  • • Testing a new treatment for obstructive cardiomyopathy, hypertrophic
  • • Phase3 - 500 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with obstructive cardiomyopathy, hypertrophic

Where?

  • • Glasgow - Lexicon Investigational Site (2712)
  • • Leicester - Lexicon Investigational Site (2713)
  • • Liverpool - Lexicon Investigational Site (2710)
  • • London - Lexicon Investigational Site (2711)

This is a simplified summary. Always discuss with your doctor before making any decisions.

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.

Obstructive Cardiomyopathy, HypertrophicNon-obstructive Hypertrophic Cardiomyopathy

How this trial compares with your answers

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

with positive

What the study is looking for

  • ✓KCCQ CSS \< 85.
  • ✓NYHA functional class II or III
  • ✓For nonobstructive hypertrophic cardiomyopathy (nHCM), LVOT peak gradient \< 30 mm Hg during screening as assessed...
  • ✓Screening left ventricular ejection fraction (LVEF) ≥ 50%, except for those on a heart myosin inhibitor (screening...

Who cannot take part

  • ✗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...
See the full 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 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.

Where Is This Study? (4 UK sites)

Lexicon Investigational Site (2712)

Glasgow G51 4TF, United Kingdom

Lexicon Investigational Site (2713)

Leicester LE3 9QP, United Kingdom

Lexicon Investigational Site (2710)

Liverpool L14 3PE, United Kingdom

Lexicon Investigational Site (2711)

London EC1M 6BQ, United Kingdom

Data sourced from ClinicalTrials.gov · Last verified: 2026-08