Recruiting

SONATA-HCMSotagliflozin for Symptomatic Hypertrophic Cardiomyopathy

Study Aim

This phase 3 study aims to evaluate how sotagliflozin affects symptoms and quality of life in people with symptomatic hypertrophic cardiomyopathy over 26 weeks.

What is being tested

Sotagliflozin

+ Placebo

Drug

Who is being recruted

Aortic Valve Disease+5

+ Aortic Stenosis, Subvalvular

+ Aortic Valve Stenosis

Over 18 Years

+25 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-ControlledPhase 3

Interventional

Study Start: September 2024

See protocol details

Summary

Principal SponsorLexicon Pharmaceuticals

Study ContactTracy Newbold

Last updated: January 29, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: September 24, 2024

Actual date on which the first participant was enrolled.

This study is focused on finding out how effective and safe a drug called sotagliflozin is for people with symptomatic hypertrophic cardiomyopathy (HCM), a condition where the heart muscle becomes abnormally thick. This thickening can make it harder for the heart to pump blood and can cause symptoms like shortness of breath, chest pain, and fainting. The study aims to see if sotagliflozin can help reduce these symptoms and improve the daily functioning of those affected by this condition. Understanding the potential benefits of this drug could lead to better treatment options for people suffering from both obstructive and non-obstructive forms of HCM. Participants in this study will receive either sotagliflozin or a placebo, which is a substance with no active drug in it, to compare the effects. The medication is likely taken orally. Researchers will closely monitor changes in symptoms and any improvements in the participants' ability to perform daily activities. While the study does not detail specific risks, monitoring ensures participant safety throughout the trial. The results will help determine if sotagliflozin can be a beneficial treatment for improving the quality of life for those with symptomatic HCM.

Official TitleA Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of SOtaglifloziN in symptomATic Obstructive And Non-obstructive Hypertrophic CardioMyopathy (SONATA-HCM)

NCT06481891

Principal SponsorLexicon Pharmaceuticals

Study ContactTracy Newbold

Last updated: January 29, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

500 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Aortic Valve DiseaseAortic Stenosis, SubvalvularAortic Valve StenosisCardiomyopathy, HypertrophicCardiovascular DiseasesHeart DiseasesHeart Valve DiseasesCardiomyopathies

Criteria

8 inclusion criteria required to participate

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.

Show More Criteria

17 exclusion criteria prevent from participating

Received therapy with a sodium glucose co-transporter 2 (SGLT2) inhibitor within the past 8 weeks prior to screening.

Current use of thiazolidinediones or digoxin.

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.

Acute coronary syndrome within 2 months prior to screening.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental

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.

Group II

Placebo

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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 103 locations

Recruiting

Lexicon Investigational Site (2911)

Târgu Mureş, RomaniaOpen Lexicon Investigational Site (2911) in Google Maps

Recruiting

Lexicon Investigational Site (2912)

Târgu Mureş, Romania

Recruiting

Lexicon Investigational Site (2312)

Belgrade, Serbia

Recruiting

Lexicon Investigational Site (4037)

Scottsdale, United States

Recruiting

103 Study Centers