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THRV-1268 in Long QT Syndrome Type 2 and Type 3
NCT07277582Phase 3
Key facts
- Status
- Recruiting
- Start
- Mar 2026
- Primary completion
- Jun 2027
- Countries
- 1
- Sponsor
- Thryv Therapeutics Inc.
- Modality
- Small Molecules
- Drugs
- THRV-1268
- Conditions
- Long QT syndrome type 2 (LQT2)Long QT Syndrome Type 3 (LQT3)
01
Overview
Phase 3, randomised trial of THRV-1268 in Long QT syndrome type 2 (LQT2) and Long QT Syndrome Type 3 (LQT3), sponsored by Thryv Therapeutics Inc. Primary endpoints: QTcF interval by AUC method at Day 84 and Incidence of Treatment-Emergent Adverse Events up to 52 weeks. Started Mar 2026; status: recruiting.
02
Design
1 arm- Study design
- Randomized
THRV-1268
3 weeks lead-in baseline followed by 50 mg BID for 6 weeks with scheduled up-titration to 100 mg BID for another 6 weeks (12 weeks total treatment)
03
Who it enrols
Participants must be >15 years old, diagnosed with LQTS 2 (KCNH2 mutation) or LQTS 3 (SCN5A mutation), have a QTcF interval between 480 and 600 ms, and BMI between 18-40. Excludes those with recent cardiac arrest, structural cardiovascular disease, active liver disease, or severe pulmonary disease.
04
Endpoints
Primary
QTcF interval by AUC method
Incidence of Treatment-Emergent Adverse Events
Secondary
QTcF interval by various methods
Maximal shortening in QTcF from pre-dose to post-dose
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