Phase 2/3 Study of Efficacy and Safety of THRV-1268 in Long QT Syndrome Type 2 (LQTS 2)
Status:
NOT_YET_RECRUITING
Trial end date:
2027-06-30
Target enrollment:
Participant gender:
Summary
The goal of this clinical trial is to learn whether the study drug THRV-1268 can safely and effectively shorten the QT interval in people diagnosed with Long QT Syndrome Type 2 (LQTS 2). The study will also learn about the safety and tolerability of THRV-1268 at different doses.
The main questions this study aims to answer are:
Does THRV-1268 reduce the QTc interval (a measure of the heart's electrical recovery time)?
What side effects or medical problems occur when participants take THRV-1268?
Which dose of THRV-1268 works best and is safest?
Participants will:
Complete a 3-week observation period with ECG and Holter monitoring to establish baseline QTc measurements Take THRV-1268 tablets twice daily at two dose levels for 6 weeks (Part A) or be randomly assigned to a dose group for 6 weeks (Part B)
Have clinic visits and tests to monitor safety and changes in their heart rhythm
May continue taking THRV-1268 for up to 1 year for ongoing safety and efficacy evaluation
Researchers will compare changes in QTc over time and evaluate side effects to determine whether THRV-1268 can help reduce the risk of abnormal heart rhythms and sudden cardiac events in people with LQTS 2.