NCT07277582

Evaluation of Efficacy and Safety of THRV-1268 in Long QT Syndrome Type 2 (LQTS 2)

A Phase 2/3, Two-part, Dose-ranging, Adaptive Study to Evaluate Efficacy and Safety of THRV-1268 in Participants Diagnosed With Long QT Syndrome Type 2 (LQTS 2)

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: Thryv Therapeutics, Inc. · Industry
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Long QT Syndrome (LQTS) 2

Interventions

Type	Name	Description
OTHER	baseline lead-in	Participants will undergo a 3 weeks run-in baseline
DRUG	THRV-1268	THRV-1268 50 mg bid (total daily 100 mg) for 6 weeks
DRUG	THRV-1268	THRV-1268 100 mg bid (total daily 200 mg) for 6 weeks

Timeline

• Start date: 2026-03-31
• Primary completion: 2027-06-30
• Completion: 2027-06-30
• First posted: 2025-12-11
• Last updated: 2026-03-30

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study