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)

Status: Recruiting
Location: See all (88) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Arizona
Lexicon Investigational Site (4037)
RECRUITING
Scottsdale
California
Lexicon Investigational Site (4012)
RECRUITING
Los Angeles
Lexicon Investigational Site (4035)
RECRUITING
Pomona
Florida
Lexicon Investigational Site (4034)
RECRUITING
Orlando
Georgia
Lexicon Investigational Site (4018)
RECRUITING
Atlanta
Illinois
Lexicon Investigational Site (4033)
RECRUITING
Evanston
Indiana
Lexicon Investigational Site (4036)
RECRUITING
Merrillville
Massachusetts
Lexicon Investigational Site (4016)
RECRUITING
Boston
Maryland
Lexicon Investigational Site (4021)
RECRUITING
Baltimore
Michigan
Lexicon Investigational Site (4028)
RECRUITING
Ann Arbor
Lexicon Investigational Site (4038)
RECRUITING
Grand Rapids
Minnesota
Lexicon Investigational Site (4027)
RECRUITING
Rochester
Missouri
Lexicon Investigational Site (4013)
RECRUITING
St Louis
North Carolina
Lexicon Investigational Site (4026)
RECRUITING
Morrisville
New Jersey
Lexicon Investigational Site (4029)
RECRUITING
Morristown
New York
Lexicon Investigational Site (4039)
RECRUITING
Manhasset
Ohio
Lexicon Investigational Site (4031)
RECRUITING
Cincinnati
Oklahoma
Lexicon Investigational Site (4024)
RECRUITING
Tulsa
Pennsylvania
Lexicon Investigational Site (4011)
RECRUITING
Philadelphia
Tennessee
Lexicon Investigational Site (4019)
RECRUITING
Germantown
Texas
Lexicon Investigational Stie (4014)
RECRUITING
Houston
Virginia
Lexicon Investigational Site (4032)
RECRUITING
Charlottesville
Wisconsin
Lexicon Investigational Site (4022)
RECRUITING
Marshfield
Lexicon Investigational Site (4040)
RECRUITING
Milwaukee
Other Locations
Argentina
Lexicon Investigational Site (5010)
RECRUITING
Córdoba
Lexicon Investigational Site (5013)
RECRUITING
Córdoba
Lexicon Investigational Site (5015)
RECRUITING
Corrientes
Lexicon Investigational Site (5012)
RECRUITING
Rosario
Lexicon Investigational Site (5011)
RECRUITING
Salta
Lexicon Investigational Site (5014)
RECRUITING
Santa Fe
Lexicon Investigational Site (5016)
RECRUITING
Santa Rosa
Belgium
Lexicon Investigational Site (1012)
RECRUITING
Genk
Brazil
Lexicon Investigational Site (5110)
RECRUITING
Campinas
Lexicon Investigational Site (5112)
RECRUITING
Recife
Bulgaria
Lexicon Investigational Site (1112)
RECRUITING
Rousse
Lexicon Investigational Site (1111)
RECRUITING
Sofia
Croatia
Lexicon Investigational Site (1215)
RECRUITING
Krapinske Toplice
Lexicon Investigational Site (1212)
RECRUITING
Opatija
Lexicon Investigational Site (1210)
RECRUITING
Rijeka
Lexicon Investigational Site (1213)
RECRUITING
Zagreb
France
Lexicon Investigational Site (1514)
RECRUITING
Chambray-lès-tours
Lexicon Investigational Site (1511)
RECRUITING
Marseille
Lexicon Investigational Site (1513)
RECRUITING
Paris
Lexicon Investigational Site (1510)
RECRUITING
Poitiers
Lexicon Investigational Site (1512)
RECRUITING
Rennes
Lexicon Investigational Site (1515)
RECRUITING
Toulouse
Georgia
Lexicon Investigational Site (1610)
RECRUITING
Tbilisi
Lexicon Investigational Site (1611)
RECRUITING
Tbilisi
Lexicon Investigational Site (1612)
RECRUITING
Tbilisi
Lexicon Investigational Site (1613)
RECRUITING
Tbilisi
Germany
Lexicon Investigational Site (2813)
RECRUITING
Berlin
Lexicon Investigational Site (2812)
RECRUITING
Hamburg
Lexicon Investigational Site (2811)
RECRUITING
Leipzig
Hungary
Lexicon Investigational Site (1710)
RECRUITING
Budapest
Lexicon Investigational Site (1711)
RECRUITING
Pécs
Lexicon Investigational Site (1713)
RECRUITING
Zalaegerszeg
Israel
Lexicon Investigational Site (7017)
RECRUITING
Be’er Ya‘aqov
Lexicon Investigational Site (7014)
RECRUITING
Haifa
Lexicon Investigational Site (7015)
RECRUITING
Holon
Lexicon Investigational Site (7011)
RECRUITING
Jerusalem
Lexicon Investigational Site (7016)
RECRUITING
Petah Tikva
Lexicon Investigational Site (7019)
RECRUITING
Tel Aviv
Italy
Lexicon Investigational Site (1814)
RECRUITING
Arezzo
Lexicon Investigational Site (1811)
RECRUITING
Brescia
Lexicon Investigational Site (1813)
RECRUITING
Napoli
Poland
Lexicon Investigational Site (2113)
RECRUITING
Lodz
Lexicon Investigational Site (2115)
RECRUITING
Oświęcim
Lexicon Investigational Site (2110)
RECRUITING
Wroclaw
Portugal
Lexicon Investigational Site (2210)
RECRUITING
Braga
Lexicon Investigational Site (2213)
RECRUITING
Faro
Lexicon Investigational Site (2211)
RECRUITING
Lisbon
Lexicon Investigational Site (2215)
RECRUITING
Lisbon
Lexicon Investigational Site (2216)
RECRUITING
Lisbon
Lexicon Investigational Site (2217)
RECRUITING
Porto
Romania
Lexicon Investigational Site (2910)
RECRUITING
Baloteşti
Lexicon Investigational Site (2913)
RECRUITING
Suceava
Lexicon Investigational Site (2911)
RECRUITING
Târgu Mureş
Lexicon Investigational Site (2912)
RECRUITING
Târgu Mureş
Serbia
Lexicon Investigational Site (2311)
RECRUITING
Belgrade
Lexicon Investigational Site (2312)
RECRUITING
Belgrade
Lexicon Investigational Site (2313)
RECRUITING
Belgrade
Lexicon Investigational Site (2314)
RECRUITING
Belgrade
Lexicon Investigational Site (2310)
RECRUITING
Niš
Sweden
Lexicon Investigational Site (2510)
RECRUITING
Stockholm
United Kingdom
Lexicon Investigational Site (2712)
RECRUITING
Glasgow
Lexicon Investigational Site (2713)
RECRUITING
Leicester
Lexicon Investigational Site (2710)
RECRUITING
Liverpool
Lexicon Investigational Site (2711)
RECRUITING
London
Contact Information
Primary
Tracy Newbold
tnewbold@lexpharma.com
281-863-3016
Time Frame
Start Date: 2024-09-24
Estimated Completion Date: 2026-08
Participants
Target number of participants: 500
Treatments
Experimental: Sotagliflozin
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.
Placebo_comparator: 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.
Sponsors
Leads: Lexicon Pharmaceuticals

This content was sourced from clinicaltrials.gov