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

NCT07277582 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2026-03-30

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Thryv Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-31
Primary Completion
2027-06-30
Completion
2027-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07277582 on ClinicalTrials.gov