At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Sotagliflozin (drug), Placebo (drug)
- How long the study runs
- Study runs about 29 months (dates as stated)
- About the drug or intervention
- Sotagliflozin — drug: Sotagliflozin will be administered as a tablet(s), orally once daily. · Placebo — drug: Placebo will be administered as a tablet(s) (identical to the sotagliflozin tablet in appearance), orally once daily.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 500
- Started
- 2024-09-24
- Last checked
- 2026-08
Plain English Summary
What is this study?
- • Testing a new treatment for obstructive cardiomyopathy, hypertrophic
- • Phase3 - 500 participants
- • 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
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with obstructive cardiomyopathy, hypertrophic
Where?
- • Glasgow - Lexicon Investigational Site (2712)
- • Leicester - Lexicon Investigational Site (2713)
- • Liverpool - Lexicon Investigational Site (2710)
- • London - Lexicon Investigational Site (2711)
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓KCCQ CSS \< 85.
- ✓NYHA functional class II or III
- ✓For nonobstructive hypertrophic cardiomyopathy (nHCM), LVOT peak gradient \< 30 mm Hg during screening as assessed...
- ✓Screening left ventricular ejection fraction (LVEF) ≥ 50%, except for those on a heart myosin inhibitor (screening...
Who cannot take part
- ✗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...
See the full criteria
Where Is This Study? (4 UK sites)
Lexicon Investigational Site (2712)
Glasgow G51 4TF, United Kingdom
Lexicon Investigational Site (2713)
Leicester LE3 9QP, United Kingdom
Lexicon Investigational Site (2710)
Liverpool L14 3PE, United Kingdom
Lexicon Investigational Site (2711)
London EC1M 6BQ, United Kingdom
