THRV-1268 for Long QT Syndrome
(Wave II Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new drug, THRV-1268, to determine if it can safely shorten the heart's reset time between beats in individuals with Long QT Syndrome Type 2 (LQTS 2), a condition that can cause abnormal rhythms. Researchers aim to discover if this treatment reduces the risk of dangerous heart rhythms and sudden cardiac events while monitoring for any side effects. Participants will take the study drug for up to a year and undergo regular check-ups to monitor heart health. The trial seeks individuals with Long QT Syndrome Type 2 and a specific genetic mutation related to the condition. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Will I have to stop taking my current medications?
The trial information does not clearly state if you must stop taking your current medications. However, it mentions that participants should not be taking or planning to take any restricted drugs, so it's best to discuss your current medications with the study team.
Is there any evidence suggesting that THRV-1268 is likely to be safe for humans?
Research has shown that the treatment THRV-1268 produced positive results in earlier studies. One study tested a single dose of THRV-1268 on adults to assess its safety and tolerability. Most participants did not experience serious side effects, even at varying dose levels, indicating it was generally well-tolerated.
The FDA approved THRV-1268 for clinical trials, suggesting a reasonable safety profile based on early testing. This approval indicates that the treatment passed initial safety checks. However, this trial will examine its safety over a longer duration and at different doses. Researchers will closely monitor participants to manage any side effects.
For those considering joining the trial, this information may be reassuring, as it demonstrates the careful steps taken to ensure the treatment's safety.12345Why do researchers think this study treatment might be promising for Long QT Syndrome?
THRV-1268 is unique because it offers a new approach for treating Long QT Syndrome by adjusting heart rhythms in a different way. Unlike traditional treatments that often rely on beta-blockers or antiarrhythmic drugs to manage symptoms, THRV-1268 specifically targets the underlying electrical activity of the heart. Researchers are excited because this targeted action could mean better symptom control with potentially fewer side effects, offering hope for improved quality of life for patients living with this condition.
What evidence suggests that THRV-1268 might be an effective treatment for Long QT Syndrome?
Research shows that THRV-1268 might help people with Long QT Syndrome Type 2 by shortening the QT interval, which is crucial because a long QT interval can lead to dangerous heart rhythms. Earlier studies demonstrated that THRV-1268 positively affects QT interval reduction. The drug targets specific proteins in the heart to promote a more normal heartbeat. Initial findings suggest it might lower the risk of sudden serious heart problems. In this trial, participants will receive THRV-1268 to determine the optimal dose and monitor for any side effects.12367
Are You a Good Fit for This Trial?
This trial is for people over 15 with Long QT Syndrome Type 2, specifically those with a certain KCNH2 mutation. They must have a QTcF interval of >480 ms to ≤600 ms and weigh at least 45 kg. Participants should not be pregnant and must agree to use effective contraception.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Observation
Participants complete a 3-week observation period with ECG and Holter monitoring to establish baseline QTc measurements
Treatment Part A
Participants take THRV-1268 tablets twice daily at two dose levels for 6 weeks
Treatment Part B
Participants are randomly assigned to a dose group for 6 weeks
Extension
Participants may continue taking THRV-1268 for up to 1 year for ongoing safety and efficacy evaluation
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- THRV-1268
Trial Overview
The study tests THRV-1268's ability to shorten the QT interval in LQTS 2 patients. It involves taking the drug twice daily for six weeks, monitoring heart rhythm changes through ECGs, and may include up to one year of treatment for ongoing assessment.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
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)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Thryv Therapeutics, Inc.
Lead Sponsor
Citations
Evaluation of Efficacy and Safety of THRV-1268 in Long QT ...
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 ...
Thryv Therapeutics Announces Positive Phase 1 Results of ...
In this population, prolonged QTc has been shown to independently predict adverse outcomes, including higher rates of all-cause mortality, ...
3.
prnewswire.com
prnewswire.com/news-releases/thryv-therapeutics-announces-fda-ind-clearance-of-thrv-1268-for-long-qt-syndrome-302559593.htmlThryv Therapeutics Announces FDA IND Clearance of ...
Details of the Phase 2/3 WAVE II Clinical Study The Phase 2/3 Wave II study will evaluate the safety and efficacy of THRV-1268 in patients with ...
4.
admarebio.com
admarebio.com/en/news-details/thryv-therapeutics-announces-positive-results-from-the-wave-1-proof-of-concept-studyThryv Therapeutics Announces Positive Results from the ...
We now have the first in human evidence of the benefits of targeting this activated kinase to reduce prolonged QTc,” commented Philip Sager, MD, ...
Thryv Therapeutics Receives FDA IND Clearance of THRV ...
New Preclinical Data Presented at ESC 2025 Results demonstrated that treatment with THRV-1268, alone or in combination with Jardiance, improved ...
NCT07186946 | Phase 1, Single Ascending Dose Study to ...
Phase 1, Single Ascending Dose Study to Evaluate the Safety, Tolerability, PK, PD, and Comparative Bioavailability of THRV-1268 in Obese Adult Participants.
LQT-1268 - Drug Targets, Indications, Patents
A First-in-Human, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study To Assess the Safety, Tolerability, ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.