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Obstructive Cardiomyopathy, HypertrophicPhase 3SONATA-HCMNCT06481891

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

A Phase 3 study testing Sotagliflozin in people with Obstructive Cardiomyopathy, Hypertrophic and Non-obstructive Hypertrophic Cardiomyopathy, run by Lexicon Pharmaceuticals at 108 sites in 19 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Sotagliflozin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
500 participants
Where
108 sitesin 19 countries
Study dates
24 Sep 2024to Feb 2027
Phase
Phase 3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 17Show fewer
  • 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.

Trial locations and contacts

108 sites in 19 countries.

108 sites in 19 countries

United States33 sites

  • Lexicon Investigational Site (4028)

    Ann Arbor, Michigan, 48109

  • Lexicon Investigational Site (4018)

    Atlanta, Georgia, 30322

  • Lexicon Investigational Site (4021)

    Baltimore, Maryland, 21218

  • Lexicon Investigational Site (4016)

    Boston, Massachusetts, 02115

  • Lexicon Investigational Site (4042)

    Boston, Massachusetts, 02118

  • Lexicon Investigational Site (4032)

    Charlottesville, Virginia, 22908

  • Lexicon Investigational Site (4031)

    Cincinnati, Ohio, 45219

  • Lexicon Investigational Site (4017)

    Cleveland, Ohio, 44195

  • Lexicon Investigational Site (4033)

    Evanston, Illinois, 60208

  • Lexicon Investigational Site (4019)

    Germantown, Tennessee, 38138

  • Lexicon Investigational Site (4038)

    Grand Rapids, Michigan, 49525

  • Lexicon Investigational Stie (4014)

    Houston, Texas, 77030

  • Lexicon Investigational Site (4046)

    Jacksonville, Florida, 32224

  • Lexicon Investigational Site (4012)

    Los Angeles, California, 90048

  • Lexicon Investigational Site (4039)

    Manhasset, New York, 11030

  • Lexicon Investigational Site (4022)

    Marshfield, Wisconsin, 54449

  • Lexicon Investigational Site (4036)

    Merrillville, Indiana, 46410

  • Lexicon Investigational Site (4040)

    Milwaukee, Wisconsin, 53215

  • Lexicon Investigational Site (4029)

    Morristown, New Jersey, 07960

  • Lexicon Investigational Site (4026)

    Morrisville, North Carolina, 27560

  • Lexicon Investigational Site (4043)

    New York, New York, 10016

  • Lexicon Investigational Site (4034)

    Orlando, Florida, 32804

  • Lexicon Investigational Site (4011)

    Philadelphia, Pennsylvania, 19104

  • Lexicon Investigational Site (4041)

    Phoenix, Arizona, 85054

  • Lexicon Investigational Site (4035)

    Pomona, California, 91767

  • Lexicon Investigational Site (4015)

    Portland, Oregon, 97239

  • Lexicon Investigational Site (4027)

    Rochester, Minnesota, 55905

  • Lexicon Investigational Site (4044)

    San Francisco, California, 94143

  • Lexicon Investigational Site (4037)

    Scottsdale, Arizona, 85260

  • Lexicon Investigational Site (4045)

    Seattle, Washington, 98101

  • Lexicon Investigational Site (4010)

    Seattle, Washington, 98195

  • Lexicon Investigational Site (4013)

    St Louis, Missouri, 63110

  • Lexicon Investigational Site (4024)

    Tulsa, Oklahoma, 74104

Other trials in United States

Israel8 sites

  • Lexicon Investigational Site (7017)

    Be’er Ya‘aqov, 7033001

  • Lexicon Investigational Site (7013)

    Haifa, 3109601

  • Lexicon Investigational Site (7014)

    Haifa, 3339419

  • Lexicon Investigational Site (7015)

    Holon, 5822012

  • Lexicon Investigational Site (7011)

    Jerusalem, 9112001

  • Lexicon Investigational Site (7016)

    Petah Tikva, 4941492

  • Lexicon Investigational Site (7012)

    Ramat Gan, 5265601

  • Lexicon Investigational Site (7019)

    Tel Aviv, 6423906

Other trials in Israel

Argentina7 sites

  • Lexicon Investigational Site (5010)

    Córdoba, 5002

  • Lexicon Investigational Site (5013)

    Córdoba, X5000AAX

  • Lexicon Investigational Site (5015)

    Corrientes, W3400CDS

  • Lexicon Investigational Site (5012)

    Rosario, Santa Fe Province, 2000

  • Lexicon Investigational Site (5011)

    Salta, 4400

  • Lexicon Investigational Site (5014)

    Santa Fe, Santa Fe Province, 3000

  • Lexicon Investigational Site (5016)

    Santa Rosa, La Pampa Province, L6304BWE

Other trials in Argentina

Portugal7 sites

  • Lexicon Investigational Site (2210)

    Braga, 4710-243

  • Lexicon Investigational Site (2213)

    Faro, 8000-386

  • Lexicon Investigational Site (2211)

    Lisbon, 1350-352

  • Lexicon Investigational Site (2215)

    Lisbon, 1500-650

  • Lexicon Investigational Site (2218)

    Lisbon, 1649-035

  • Lexicon Investigational Site (2216)

    Lisbon, 1998-018

  • Lexicon Investigational Site (2217)

    Porto, 4200-319

Other trials in Portugal

France6 sites

  • Lexicon Investigational Site (1514)

    Chambray-lès-Tours, 37170

  • Lexicon Investigational Site (1511)

    Marseille, 13005

  • Lexicon Investigational Site (1513)

    Paris, 75651

  • Lexicon Investigational Site (1510)

    Poitiers, 86021

  • Lexicon Investigational Site (1512)

    Rennes, 35033

  • Lexicon Investigational Site (1515)

    Toulouse, 31059

Other trials in France

Serbia5 sites

  • Lexicon Investigational Site (2312)

    Belgrade, 11000

  • Lexicon Investigational Site (2314)

    Belgrade, 11000

  • Lexicon Investigational Site (2311)

    Belgrade, 11040

  • Lexicon Investigational Site (2313)

    Belgrade, 11040

  • Lexicon Investigational Site (2310)

    Niš, 18108

Other trials in Serbia

Brazil4 sites

  • Lexicon Investigational Site (5110)

    Campinas, São Paulo, 13060-080

  • Lexicon Investigational Site (5112)

    Recife, 52051-380

  • Lexicon Investigational Site (5114)

    Salvador, Estado de Bahia, 40170-130

  • Lexicon Investigational Site (5115)

    São Paulo, 04039-000

Other trials in Brazil

Croatia4 sites

  • Lexicon Investigational Site (1215)

    Krapinske Toplice, 49217

  • Lexicon Investigational Site (1212)

    Opatija, 51410

  • Lexicon Investigational Site (1210)

    Rijeka, 51000

  • Lexicon Investigational Site (1213)

    Zagreb, 10000

Other trials in Croatia

Georgia4 sites

  • Lexicon Investigational Site (1611)

    Tbilisi, 0112

  • Lexicon Investigational Site (1610)

    Tbilisi, 0131

  • Lexicon Investigational Site (1612)

    Tbilisi, 0144

  • Lexicon Investigational Site (1613)

    Tbilisi, 0186

Other trials in Georgia

Germany4 sites

  • Lexicon Investigational Site (2813)

    Berlin, 13353

  • Lexicon Investigational Site (2812)

    Hamburg, 22041

  • Lexicon Investigational Site (2811)

    Leipzig, 04289

  • Lexicon Investigational Site (2810)

    München, 80336

Other trials in Germany

Hungary4 sites

  • Lexicon Investigational Site (1710)

    Budapest, 1122

  • Lexicon Investigational Site (1711)

    Pécs, 7624

  • Lexicon Investigational Site (1712)

    Szeged, 6725

  • Lexicon Investigational Site (1713)

    Zalaegerszeg, 8900

Other trials in Hungary

Poland4 sites

  • Lexicon Investigational Site (2114)

    Lodz, 91-347

  • Lexicon Investigational Site (2113)

    Lodz, 92-213

  • Lexicon Investigational Site (2115)

    Oświęcim, 32-600

  • Lexicon Investigational Site (2110)

    Wroclaw, 50-981

Other trials in Poland

Romania4 sites

  • Lexicon Investigational Site (2910)

    Baloteşti, 077015

  • Lexicon Investigational Site (2913)

    Suceava, 720049

  • Lexicon Investigational Site (2911)

    Târgu Mureş, 540124

  • Lexicon Investigational Site (2912)

    Târgu Mureş, 540143

Other trials in Romania

United Kingdom4 sites

  • Lexicon Investigational Site (2712)

    Glasgow, G51 4TF

  • Lexicon Investigational Site (2713)

    Leicester, LE3 9QP

  • Lexicon Investigational Site (2710)

    Liverpool, L14 3PE

  • Lexicon Investigational Site (2711)

    London, EC1M 6BQ

Other trials in United Kingdom

Czechia3 sites

  • Lexicon Investigational Site (1311)

    Brno, 602 00

  • Lexicon Investigational Site (1310)

    Prague, 128 08

  • Lexicon Investigational Site (1312)

    Ústí nad Labem, 400 11

Other trials in Czechia

Italy3 sites

  • Lexicon Investigational Site (1814)

    Arezzo, 52100

  • Lexicon Investigational Site (1811)

    Brescia, 25123

  • Lexicon Investigational Site (1813)

    Naples, 80131

Other trials in Italy

Bulgaria2 sites

  • Lexicon Investigational Site (1112)

    Rousse, 7013

  • Lexicon Investigational Site (1111)

    Sofia, 1407

Other trials in Bulgaria

Belgium1 site

  • Lexicon Investigational Site (1012)

    Genk, 3600

Other trials in Belgium

Sweden1 site

  • Lexicon Investigational Site (2510)

    Stockholm, 17164

Other trials in Sweden

About this study

Official title: A 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)

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.

Being tested
Sotagliflozin, Placebo
Medical subject headings
Cardiomyopathy, Hypertrophic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SotagliflozinDrug

    Also called SAR439954/LX4211

    Sotagliflozin will be administered as a tablet(s), orally once daily.

  • PlaceboDrug

    Also called SAR439954/LX4211

    Placebo will be administered as a tablet(s) (identical to the sotagliflozin tablet in appearance), orally once daily.

Study groups in NCT06481891
Study groupRoleWhat they receive
SotagliflozinExperimentalFollowing 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.
Receives: Drug: Sotagliflozin
PlaceboPlacebo comparatorFollowing 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.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline to Week 26 in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ CSS)

    KCCQ is a 23-item, self-administered questionnaire that measure the participant's perception of their health status, including their heart failure (HF) symptoms, impact on physical and social function and how their HF impacts the quality of life. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores are generated for each domain and scaled from 0 to 100, with 0 denoting the worst and 100 the best possible status. Higher scores reflect better health status.

    Measured: Baseline to Week 26

Secondary outcomes (2)

  1. Percentage of Participants at Week 26 with a New York Heart Association (NYHA) Functional Class Improvement ≥ 1 Category

    NYHA functional class is a clinician-reported assessment of participants' health status on a 4-point scale, where Class I represents no limitations in normal activity; Class II indicates slight limitation of physical activity; Class III indicates marked limitation in physical activity; and Class IV indicates that participants have symptoms with any physical activity or at rest. Percentage of participants with NYHA functional class improvement ≥1 will be reported.

    Measured: Week 26

  2. Change from Baseline to Week 26 in KCCQ Total Symptom Score (TSS).

    KCCQ is a 23-item, self-administered questionnaire that measure the participant's perception of their health status, including their HF symptoms, impact on physical and social function and how their HF impacts the quality of life. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores are generated for each domain and scaled from 0 to 100, with 0 denoting the worst and 100 the best possible status. Higher scores reflect better health status.

    Measured: Baseline to Week 26

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jul 2024
  2. Study start24 Sep 2024
  3. Primary completionJan 2027 (estimated)
  4. Study completionFeb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06481891
Sponsor's protocol ID
LX4211.1-314-HCM
Acronym
SONATA-HCM
Status last verified
Aug 2026
First submitted
25 Jun 2024
Last updated
26 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

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