SONATA-HCM
Research type
Research Study
Full 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).
IRAS ID
1010191
Contact name
Tracy Newbold
Contact email
Sponsor organisation
Lexicon Pharmaceuticals, Inc.
Eudract number
2024-513869-39
Clinicaltrials.gov Identifier
Research summary
The purpose of this study is to determine the effect of the study drug, sotagliflozin, in people with Hypertrophic cardiomyopathy (HCM), measured by changes in signs and symptoms of the disease, and how safe it is.
HCM is a common heart condition that can cause irregular heartbeats, heart failure and possibly sudden death. This condition is linked to genes, and causes thickening of the heart muscle, which can impact the blood flow leaving the heart (obstructive HCM) or make it more difficult for the heart chambers to fill and then empty properly (non obstructive HCM). Clinical management of HCM focuses on relieving symptoms of the disease. Sotagliflozin has been shown to improve symptoms in people with heart failure, a different type of heart condition. Sotagliflozin is a drug that controls blood sugar by slowing gut absorption and boosting helpful hormones. In the kidneys, it blocks glucose, leading to calorie loss and potentially lowering body weight and blood pressure. These actions might indirectly ease stress on the heart, which makes sotagliflozin a potential treatment for both obstructive and non obstructive HCM.
This trial is designed to evaluate approximately 500 participants globally, with obstructive or non-obstructive HCM. Study participants will receive sotagliflozin or placebo once daily for 26 weeks and will be followed for 4 more weeks after treatment is stopped. Over a period of up to around 32 weeks, study participants will visit the clinic at least 6 times and will be contacted 2 times during the study by phone to check on their well-being. Study participants will be asked to fill out questionnaires and will be monitored for health issues and side effects, heart function, physical examination, vital signs, and will have their blood collected.
The study is sponsored by Lexicon Pharmaceuticals Inc.REC name
London - Riverside Research Ethics Committee
REC reference
24/LO/0768
Date of REC Opinion
12 Nov 2024
REC opinion
Further Information Favourable Opinion