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Could a diabetes drug help heart muscle disease? large trial underway

NCT ID NCT06481891

Symptom relief Sponsor: Lexicon Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 27, 2026 · Updated 6 times

Summary

This Phase 3 study tests whether the drug sotagliflozin can improve symptoms and daily function in 500 adults with hypertrophic cardiomyopathy (HCM), a condition where the heart muscle thickens. Participants take either the drug or a placebo pill once daily for 26 weeks. The main goal is to see if symptoms like shortness of breath and fatigue get better, measured by a standard heart-disease questionnaire.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
sotagliflozin
What this could lead to
If it works, this could offer a new daily pill to ease symptoms and improve quality of life for people with hypertrophic cardiomyopathy.
What could go wrong
This is a Phase 3 trial, but it is still experimental. The drug may not prove more effective than placebo, and side effects are possible.
Why investors are watching

Lexicon Pharmaceuticals is running a Phase 3 trial of sotagliflozin in 500 patients with symptomatic hypertrophic cardiomyopathy, a heart condition that causes chest pain and breathlessness. For a small company, this late-stage readout is a major event because a positive result could lead to a new approved use for the drug, while a negative result would leave the company without a key growth driver.

If it works: If the trial shows sotagliflozin eases symptoms better than placebo, Lexicon could seek regulatory approval for a new indication, expanding the drug's market beyond its current uses. That outcome would give the company a second product line and a reason for investors to expect higher future revenue.

If it fails: Phase 3 trials often fail, and if sotagliflozin does not beat placebo on symptom relief, Lexicon would have spent years and millions of dollars without a new approval. A delay in enrollment or data readout would also push back any potential commercial benefit, leaving the company dependent on its existing sales.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 500 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2024

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

hypertrophic cardiomyopathy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Non-obstructive hypertrophic cardiomyopathy Obstructive cardiomyopathy, hypertrophic

Contacts and locations

Locations

  • Lexicon Investigational Site (1012)

    Genk, 3600, Belgium

  • Lexicon Investigational Site (1111)

    Sofia, 1407, Bulgaria

  • Lexicon Investigational Site (1112)

    Rousse, 7013, Bulgaria

  • Lexicon Investigational Site (1210)

    Rijeka, 51000, Croatia

  • Lexicon Investigational Site (1212)

    Opatija, 51410, Croatia

  • Lexicon Investigational Site (1213)

    Zagreb, 10000, Croatia

  • Lexicon Investigational Site (1215)

    Krapinske Toplice, 49217, Croatia

  • Lexicon Investigational Site (1310)

    Prague, 128 08, Czechia

  • Lexicon Investigational Site (1311)

    Brno, 602 00, Czechia

  • Lexicon Investigational Site (1312)

    Ústí nad Labem, 400 11, Czechia

  • Lexicon Investigational Site (1510)

    Poitiers, 86021, France

  • Lexicon Investigational Site (1511)

    Marseille, 13005, France

  • Lexicon Investigational Site (1512)

    Rennes, 35033, France

  • Lexicon Investigational Site (1513)

    Paris, 75651, France

  • Lexicon Investigational Site (1514)

    Chambray-lès-Tours, 37170, France

  • Lexicon Investigational Site (1515)

    Toulouse, 31059, France

  • Lexicon Investigational Site (1610)

    Tbilisi, 0131, Georgia

  • Lexicon Investigational Site (1611)

    Tbilisi, 0112, Georgia

  • Lexicon Investigational Site (1612)

    Tbilisi, 0144, Georgia

  • Lexicon Investigational Site (1613)

    Tbilisi, 0186, Georgia

  • Lexicon Investigational Site (1710)

    Budapest, 1122, Hungary

  • Lexicon Investigational Site (1711)

    Pécs, 7624, Hungary

  • Lexicon Investigational Site (1712)

    Szeged, 6725, Hungary

  • Lexicon Investigational Site (1713)

    Zalaegerszeg, 8900, Hungary

  • Lexicon Investigational Site (1811)

    Brescia, 25123, Italy

  • Lexicon Investigational Site (1813)

    Naples, 80131, Italy

  • Lexicon Investigational Site (1814)

    Arezzo, 52100, Italy

  • Lexicon Investigational Site (2110)

    Wroclaw, 50-981, Poland

  • Lexicon Investigational Site (2113)

    Lodz, 92-213, Poland

  • Lexicon Investigational Site (2114)

    Lodz, 91-347, Poland

  • Lexicon Investigational Site (2115)

    Oświęcim, 32-600, Poland

  • Lexicon Investigational Site (2210)

    Braga, 4710-243, Portugal

  • Lexicon Investigational Site (2211)

    Lisbon, 1350-352, Portugal

  • Lexicon Investigational Site (2213)

    Faro, 8000-386, Portugal

  • Lexicon Investigational Site (2215)

    Lisbon, 1500-650, Portugal

  • Lexicon Investigational Site (2216)

    Lisbon, 1998-018, Portugal

  • Lexicon Investigational Site (2217)

    Porto, 4200-319, Portugal

  • Lexicon Investigational Site (2218)

    Lisbon, 1649-035, Portugal

  • Lexicon Investigational Site (2310)

    Niš, 18108, Serbia

  • Lexicon Investigational Site (2311)

    Belgrade, 11040, Serbia

  • Lexicon Investigational Site (2312)

    Belgrade, 11000, Serbia

  • Lexicon Investigational Site (2313)

    Belgrade, 11040, Serbia

  • Lexicon Investigational Site (2314)

    Belgrade, 11000, Serbia

  • Lexicon Investigational Site (2510)

    Stockholm, 17164, Sweden

  • Lexicon Investigational Site (2710)

    Liverpool, L14 3PE, United Kingdom

  • Lexicon Investigational Site (2711)

    London, EC1M 6BQ, United Kingdom

  • Lexicon Investigational Site (2712)

    Glasgow, G51 4TF, United Kingdom

  • Lexicon Investigational Site (2713)

    Leicester, LE3 9QP, United Kingdom

  • Lexicon Investigational Site (2810)

    München, 80336, Germany

  • Lexicon Investigational Site (2811)

    Leipzig, 04289, Germany

  • Lexicon Investigational Site (2812)

    Hamburg, 22041, Germany

  • Lexicon Investigational Site (2813)

    Berlin, 13353, Germany

  • Lexicon Investigational Site (2910)

    Baloteşti, 077015, Romania

  • Lexicon Investigational Site (2911)

    Târgu Mureş, 540124, Romania

  • Lexicon Investigational Site (2912)

    Târgu Mureş, 540143, Romania

  • Lexicon Investigational Site (2913)

    Suceava, 720049, Romania

  • Lexicon Investigational Site (4010)

    Seattle, Washington, 98195, United States

  • Lexicon Investigational Site (4011)

    Philadelphia, Pennsylvania, 19104, United States

  • Lexicon Investigational Site (4012)

    Los Angeles, California, 90048, United States

  • Lexicon Investigational Site (4013)

    St Louis, Missouri, 63110, United States

  • Lexicon Investigational Site (4015)

    Portland, Oregon, 97239, United States

  • Lexicon Investigational Site (4016)

    Boston, Massachusetts, 02115, United States

  • Lexicon Investigational Site (4017)

    Cleveland, Ohio, 44195, United States

  • Lexicon Investigational Site (4018)

    Atlanta, Georgia, 30322, United States

  • Lexicon Investigational Site (4019)

    Germantown, Tennessee, 38138, United States

  • Lexicon Investigational Site (4021)

    Baltimore, Maryland, 21218, United States

  • Lexicon Investigational Site (4022)

    Marshfield, Wisconsin, 54449, United States

  • Lexicon Investigational Site (4024)

    Tulsa, Oklahoma, 74104, United States

  • Lexicon Investigational Site (4026)

    Morrisville, North Carolina, 27560, United States

  • Lexicon Investigational Site (4027)

    Rochester, Minnesota, 55905, United States

  • Lexicon Investigational Site (4028)

    Ann Arbor, Michigan, 48109, United States

  • Lexicon Investigational Site (4029)

    Morristown, New Jersey, 07960, United States

  • Lexicon Investigational Site (4031)

    Cincinnati, Ohio, 45219, United States

  • Lexicon Investigational Site (4032)

    Charlottesville, Virginia, 22908, United States

  • Lexicon Investigational Site (4033)

    Evanston, Illinois, 60208, United States

  • Lexicon Investigational Site (4034)

    Orlando, Florida, 32804, United States

  • Lexicon Investigational Site (4035)

    Pomona, California, 91767, United States

  • Lexicon Investigational Site (4036)

    Merrillville, Indiana, 46410, United States

  • Lexicon Investigational Site (4037)

    Scottsdale, Arizona, 85260, United States

  • Lexicon Investigational Site (4038)

    Grand Rapids, Michigan, 49525, United States

  • Lexicon Investigational Site (4039)

    Manhasset, New York, 11030, United States

  • Lexicon Investigational Site (4040)

    Milwaukee, Wisconsin, 53215, United States

  • Lexicon Investigational Site (4041)

    Phoenix, Arizona, 85054, United States

  • Lexicon Investigational Site (4042)

    Boston, Massachusetts, 02118, United States

  • Lexicon Investigational Site (4043)

    New York, New York, 10016, United States

  • Lexicon Investigational Site (4044)

    San Francisco, California, 94143, United States

  • Lexicon Investigational Site (4045)

    Seattle, Washington, 98101, United States

  • Lexicon Investigational Site (4046)

    Jacksonville, Florida, 32224, United States

  • Lexicon Investigational Site (5010)

    Córdoba, 5002, Argentina

  • Lexicon Investigational Site (5011)

    Salta, 4400, Argentina

  • Lexicon Investigational Site (5012)

    Rosario, Santa Fe Province, 2000, Argentina

  • Lexicon Investigational Site (5013)

    Córdoba, X5000AAX, Argentina

  • Lexicon Investigational Site (5014)

    Santa Fe, Santa Fe Province, 3000, Argentina

  • Lexicon Investigational Site (5015)

    Corrientes, W3400CDS, Argentina

  • Lexicon Investigational Site (5016)

    Santa Rosa, La Pampa Province, L6304BWE, Argentina

  • Lexicon Investigational Site (5110)

    Campinas, São Paulo, 13060-080, Brazil

  • Lexicon Investigational Site (5112)

    Recife, 52051-380, Brazil

  • Lexicon Investigational Site (5114)

    Salvador, Estado de Bahia, 40170-130, Brazil

  • Lexicon Investigational Site (5115)

    São Paulo, 04039-000, Brazil

  • Lexicon Investigational Site (7011)

    Jerusalem, 9112001, Israel

  • Lexicon Investigational Site (7012)

    Ramat Gan, 5265601, Israel

  • Lexicon Investigational Site (7013)

    Haifa, 3109601, Israel

  • Lexicon Investigational Site (7014)

    Haifa, 3339419, Israel

  • Lexicon Investigational Site (7015)

    Holon, 5822012, Israel

  • Lexicon Investigational Site (7016)

    Petah Tikva, 4941492, Israel

  • Lexicon Investigational Site (7017)

    Be’er Ya‘aqov, 7033001, Israel

  • Lexicon Investigational Site (7019)

    Tel Aviv, 6423906, Israel

  • Lexicon Investigational Stie (4014)

    Houston, Texas, 77030, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.