Thryv Therapeutics Inc. Wave II Clinical Trial for Long QT Syndrome Type 2

Now enrolling patients with Long QT Syndrome Type 2 (affecting the KCNH2 gene)

Quick Facts 

📌Trial: Wave Study II
📌 Studying: Whether the trial drug (called THRV-1268) taken orally twice daily can safely and effectively shorten the QT interval in people diagnosed with Long QT Syndrome Type 2 (LQTS 2) and QTc greater than 480 milliseconds. The study will also learn about the safety and tolerability of the trial drug at different doses.
📌 Condition: Long QT Syndrome Type 2 (evidence of  KCNH2 gene mutation).
📌 Ages:  Over 15 years of age at screening (at least the first 5 participants enrolled must be 18 years of age or older).
📌 Sites: Currently enrolling at a network of sites in the United States (https://clinicaltrials.gov/study/NCT07277582)
📌 Status: Now Enrolling

What drug is being investigated, and how does it work?

The goal of this clinical trial is to learn whether the trial drug (called THRV-1268) can safely and effectively shorten the QT interval in people diagnosed with Long QT Syndrome Type 2 (LQTS 2). THRV-1268 is a class of drug called a serum and glucocorticoid regulated kinase inhibitor (SGK1-i) and is taken by mouth twice daily. The study will also teach us about the safety and tolerability of this trial drug at different doses.

The main questions this study aims to answer are:

• Does this trial drug reduce the QTc interval?
• Do any side effects or medical problems occur when participants take the trial drug?
• Which dose of the trial drug works best and is safest?

What is a Clinical Trial?
Learn more about clinical trials – including frequently asked questions and questions you may have as you consider whether participation is right for you – here.

• Confirmed diagnosis of Long QT Syndrome with a pathogenic or likely mutation in KCNH2.
• Over 15 years of age at screening (at least the first 5 participants enrolled must be 18 years of age or older).
• QTc interval >480 ms and ≤600 ms (based on ECG at screening).

You may NOT be eligible to participate if:

• You’ve had a Sudden Cardiac Arrest, ICD implantation, or syncopal (fainting) episode due to your heart in the last two months.
• You have a pacemaker or ICD that is actively used for ventricular pacing.
• You currently take and plan to continue taking Mexiletine

Full eligibility criteria will be evaluated by the researcher to determine if an individual is the right candidate for this study.

FAQs 

What is involved in participating? 

Participants:

• Complete a 3-week baseline period with health checks, including ECG and Holter monitoring to establish baseline QTc measurements prior to starting to take the investigational medication. The 3-week baseline period will include attending at least two on-site visits (scheduled one week apart).
• Complete one on-site visit on the first day of dosing, and biweekly safety visits during the treatment period, including on-site visits with Holter monitoring at Weeks 6 and 12. Home health visits will be available for select visits if needed.
• During the treatment period take capsules twice a day of the trial drug (THRV-1268) as instructed. The dose will be taken first for 6 weeks and then increased for an additional 6 weeks.
• After the 12-week treatment period, there is a 40-week safety follow-up period in which the dose of the trial drug (THRV-1268) will continue to be taken twice a day as instructed. The dose may be adjusted based on the data collected during the study.
• May continue taking the trial drug for up to 1 year for ongoing safety and efficacy evaluations.
• Have clinic visits and tests to monitor safety and changes in their heart rhythm. Some visits may also be able to be conducted at home.

Can the study drug help reduce QTc over time?

Researchers will compare changes in QTc over time and evaluate side effects to determine whether the trial drug can help lower the risk of abnormal heart rhythms and sudden cardiac events in people with LQTS 2 by reducing the QTc.

What if I change my mind about participating?

You can withdraw from the study whenever you wish. If you decide to do so, please talk with your doctor to discuss any follow-up care you may need.

Can I stay on my current treatment?

Participants will be asked to discuss all medications they are currently taking with the study doctor to ensure their treatments don’t conflict with the requirements of the study.

Where are the trial sites and how often would I need to travel there?

Travel to the study site will be coordinated and expenses covered by the study team for participants and their caregivers. Additionally, select study visits may be conducted through home health services.

Will the costs of participating in the trial be covered by Thryv Therapeutics Inc.?

Yes! The trial drug and all study-related assessments will be provided at no cost. You will also be reimbursed for reasonable study-related expenses, and a participant stipend will be provided for each completed visit.

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