Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and current medications.

Eligibility criteria include a diagnosis of hypertrophic cardiomyopathy (HCM) with specific characteristics, such as left ventricular hypertrophy and a stable dose of any current cardiac medications.

Participants are randomly assigned to receive either the sotagliflozin medication or a placebo. This process is double-blind, meaning neither the participant nor the study team knows which treatment is being administered.

The medication, sotagliflozin, is taken orally. The specific dosage and frequency are determined by the study protocol and are provided to the participant at the start of the trial.

The duration of medication administration is up to 26 weeks, during which the participant’s symptoms and functional limitations are monitored.

Throughout the trial, regular monitoring is conducted to assess the participant’s health and response to the treatment. This includes clinical laboratory tests, vital signs, and echocardiograms to measure heart function.

Participants are evaluated for any treatment-emergent adverse events (TEAEs) and changes in their condition.

At the end of the 26-week period, the primary outcome is assessed by measuring changes in the Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score.

Secondary outcomes include improvements in New York Heart Association (NYHA) functional class, changes in symptom scores, and any adverse events reported.

A follow-up period extends to Week 30 to monitor any ongoing effects of the treatment and to ensure participant safety after the trial medication has been completed.