Sotagliflozin for Hypertrophic Cardiomyopathy
(SONATA-HCM Trial)
What You Need to Know Before You Apply
What is the purpose of 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.
Do I need to stop my current medications for the trial?
The trial protocol does not specify if you need to stop your current medications. However, you must have stable doses of certain medications like β-blockers, calcium channel blockers, ACE inhibitors, angiotensin receptor blockers, and diuretics for at least 1 month before screening. You cannot use thiazolidinediones or digoxin, and you must not have used an SGLT2 inhibitor in the past 8 weeks.
What safety data exists for sotagliflozin?
Sotagliflozin has been evaluated for safety in various clinical trials. In the inTANDEM 1-3 trials for type 1 diabetes, it was generally well tolerated, though it carries a risk of diabetic ketoacidosis. In heart failure studies, such as the SOLOIST-WHF trial, it demonstrated efficacy and safety in patients with type 2 diabetes and heart failure. The SOTA-P-CARDIA trial is investigating its safety and efficacy in non-diabetic heart failure patients. Overall, sotagliflozin has shown a favorable safety profile in these contexts.12345
Is the drug Sotagliflozin a promising treatment for Hypertrophic Cardiomyopathy?
What data supports the idea that Sotagliflozin for Hypertrophic Cardiomyopathy is an effective drug?
The available research shows that Sotagliflozin has been effective in treating heart failure in patients with type 2 diabetes, as demonstrated in the SOLOIST-WHF trial. While the research does not specifically mention Hypertrophic Cardiomyopathy, the drug has shown benefits in heart failure management, which may suggest potential effectiveness for related heart conditions. However, there is no direct data provided on its use for Hypertrophic Cardiomyopathy specifically.12347
Are You a Good Fit for This Trial?
This trial is for individuals with symptomatic hypertrophic cardiomyopathy (HCM), which is a condition where the heart muscle becomes abnormally thick. Participants should have symptoms and limitations due to HCM but specific inclusion and exclusion criteria details are not provided.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either sotagliflozin or placebo for up to 26 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Sotagliflozin
Sotagliflozin is already approved in European Union, United States for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Lexicon Pharmaceuticals
Lead Sponsor
Dr. Mike Exton
Lexicon Pharmaceuticals
Chief Executive Officer
PhD in Neuroscience from the University of Newcastle and PhD in Immunology from the University of Essen, Germany
Dr. Craig Granowitz
Lexicon Pharmaceuticals
Chief Medical Officer since 2021
MD