Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

Study on Sotagliflozin for Improving Symptoms in Patients with Hypertrophic Cardiomyopathy

Verified siteRegistered drug
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a heart condition known as Hypertrophic Cardiomyopathy (HCM), which can be either obstructive or non-obstructive. HCM is a disease where the heart muscle becomes thickened, which can make it harder for the heart to pump blood. The study is testing a medication called Sotagliflozin, which is taken as a film-coated tablet. The purpose of the study is to see if Sotagliflozin can improve symptoms and is safe for people with this condition.

Participants in the study will be randomly assigned to receive either Sotagliflozin or a placebo, which looks like the medication but does not contain the active ingredient. The study will last for about 26 weeks, during which participants will take the medication and have regular check-ups to monitor their health and any changes in their symptoms. The study aims to understand how the medication affects the symptoms and daily life of people with HCM.

Throughout the study, participants will be asked to complete questionnaires about their symptoms and how they feel. They will also undergo tests like echocardiograms, which use sound waves to create images of the heart, to measure changes in the heart's function. The study will help determine if Sotagliflozin can be a beneficial treatment option for people with Hypertrophic Cardiomyopathy.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and current medications.

    Eligibility criteria include a diagnosis of hypertrophic cardiomyopathy (HCM) with specific characteristics, such as left ventricular hypertrophy and a stable dose of any current cardiac medications.

  2. Step 2

    Randomization

    Participants are randomly assigned to receive either the sotagliflozin medication or a placebo. This process is double-blind, meaning neither the participant nor the study team knows which treatment is being administered.

  3. Step 3

    Medication administration

    The medication, sotagliflozin, is taken orally. The specific dosage and frequency are determined by the study protocol and are provided to the participant at the start of the trial.

    The duration of medication administration is up to 26 weeks, during which the participant's symptoms and functional limitations are monitored.

  4. Step 4

    Regular monitoring

    Throughout the trial, regular monitoring is conducted to assess the participant's health and response to the treatment. This includes clinical laboratory tests, vital signs, and echocardiograms to measure heart function.

    Participants are evaluated for any treatment-emergent adverse events (TEAEs) and changes in their condition.

  5. Step 5

    Evaluation of outcomes

    At the end of the 26-week period, the primary outcome is assessed by measuring changes in the Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score.

    Secondary outcomes include improvements in New York Heart Association (NYHA) functional class, changes in symptom scores, and any adverse events reported.

  6. Step 6

    Follow-up

    A follow-up period extends to Week 30 to monitor any ongoing effects of the treatment and to ensure participant safety after the trial medication has been completed.

Who can join the trial?

11 criteria

  • Must have a condition called **Hypertrophic Cardiomyopathy (HCM)**, which can be either **obstructive** or **non-obstructive**.
  • Must have a **KCCQ CSS** score of less than 85. This is a score that measures heart failure symptoms and their impact on daily life.
  • Must be in **NYHA functional class II or III**, which means experiencing some limitations in physical activity due to heart symptoms.
  • Must have a diagnosis of **HCM** according to specific guidelines, which includes having a thickened heart muscle wall of at least 15 millimeters, or 13 millimeters if there is a family history of HCM.
  • For those with **obstructive HCM**, the heart's outflow tract must have a pressure of at least 30 millimeters of mercury during screening.
  • For those with **non-obstructive HCM**, the heart's outflow tract must have a pressure of less than 30 millimeters of mercury during screening.
  • Must have a **left ventricular ejection fraction (LVEF)** of at least 50%, which measures how well the heart pumps blood, except for those on a specific heart medication, who need an LVEF of at least 55%.
  • If taking a **cardiac myosin inhibitor** (a type of heart medication), the dose must be stable for at least 3 months before screening and should not be increased during the trial.
  • Must be on stable doses of other heart medications like **beta-blockers**, **calcium channel blockers**, **ACE inhibitors**, **angiotensin receptor blockers**, or **diuretics** for at least 1 month before screening.
  • Participants can be of any gender.
  • Participants must be adults, as the age range includes categories 3 and 4, which typically refer to adults.

Who cannot join the trial?

10 criteria

  • Patients with other serious heart conditions that are not related to hypertrophic cardiomyopathy cannot participate.
  • Individuals with severe kidney problems are excluded from the study.
  • Patients who have had a heart attack in the last three months are not eligible.
  • People with uncontrolled high blood pressure cannot join the trial.
  • Participants who are currently using certain medications that might interfere with the study treatment are excluded.
  • Pregnant or breastfeeding women are not allowed to participate.
  • Individuals with a history of severe allergic reactions to similar medications are excluded.
  • Patients with active infections that require treatment are not eligible.
  • People with a history of drug or alcohol abuse in the past year cannot participate.
  • Individuals who have participated in another clinical trial within the last 30 days are excluded.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Sotagliflozin is a medication being studied for its potential to help people with hypertrophic cardiomyopathy, a condition where the heart muscle becomes abnormally thick. This medication is being tested to see if it can improve symptoms and help patients with this heart condition feel better and function more easily in their daily lives.

What is already known about the treatment

Sotagliflozin – Sotagliflozin is administered orally in tablet form. It is currently being studied in clinical trials for its potential benefits in treating symptomatic obstructive and non-obstructive hypertrophic cardiomyopathy. The main therapeutic indication is to alleviate symptoms and improve functional limitations in patients with this condition. At the molecular level, sotagliflozin works by inhibiting certain proteins involved in glucose reabsorption in the kidneys, which may also have beneficial effects on heart function. It is classified as a dual SGLT1 and SGLT2 inhibitor, which are types of proteins involved in glucose transport.

Investigated diseases

  • Obstructive Hypertrophic Cardiomyopathy

    This condition is characterized by the thickening of the heart muscle, particularly affecting the septum between the ventricles, which can obstruct blood flow out of the heart. As the heart muscle thickens, it can lead to increased stiffness, making it harder for the heart to fill with blood. Over time, this can cause symptoms such as shortness of breath, chest pain, and palpitations. The obstruction can also lead to increased pressure in the heart chambers, potentially causing further complications. The severity of symptoms can vary widely among individuals.

  • Non-obstructive Hypertrophic Cardiomyopathy

    In this form of hypertrophic cardiomyopathy, the heart muscle is thickened, but there is no significant obstruction to blood flow. The thickened muscle can still lead to stiffness, reducing the heart's ability to fill properly with blood. This can result in symptoms like fatigue, shortness of breath, and chest discomfort. Unlike the obstructive form, the absence of a blockage means that blood flow is not directly impeded, but the heart's efficiency is still compromised. The progression of symptoms can vary, and some individuals may remain asymptomatic for extended periods.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-513869-39-00Protocol codeLX4211.1-314-HCMEstimated enrolment500 patientsSponsorLexicon Pharmaceuticals Inc.

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.