Pivotal Study: A Phase 2/3 Study Evaluating the Efficacy and Safety of THRV-1268 in Adults with Long QT Syndrome Type 2 (LQTS2).
Enrollment is now open for eligible participants.
About Wave II
Wave II is a Phase 2/3 clinical research study for people diagnosed with Long QT Syndrome Type 2 (LQTS2).
The study is evaluating an investigational medication called THRV-1268, an oral medication taken twice daily. THRV-1268 is a serum glucocorticoid-regulated kinase 1 (SGK1) inhibitor being developed to understand whether it may help support healthier, more stable heart rhythms in people with LQTS2.
Wave II is sponsored by Thryv Therapeutics Inc., a company dedicated to advancing new treatment options for inherited cardiac rhythm conditions.
If you or a loved one lives with LQTS2, you may be interested in learning more about whether this study could be a good fit.
To learn more, visit: ClinicalTrials.gov
The safety and efficacy of THRV-1268 have not yet been established. THRV-1268 has not been approved for commercial use by any regulatory authority (e.g. the FDA in the United States or Health Canada in Canada).
Why This Study Is Being Conducted
People with LQTS2 often live with the uncertainty of when symptoms may occur and how their heart rythm may respond to daily activities.
Heart Rhythm
How the investigational medication may affect the heart's QT interval
Safety Profile
Whether the investigational medication is safe and well-tolerated in people with LQTS2
Future Options
How this approach may contribute to future treatment options
Every participant who joins the study contributes to important scientific understanding that may help them, their family members, and others in the LQTS community.
What Participation Involves
Taking part in Wave II includes several study visits over the first 4 months of participation and up to one year on the investigational study medication. During the study, participants will:
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Participants in Wave II will take the investigational study medication as instructed by the clinical research team. The team will explain how to take it, what to do if a dose is missed, and how the investigational study medication will be provided and stored. You’ll also be told who to contact with questions or if you experience side effects.
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ECGs help the research team understand how your heart rhythm changes during the study. They are non-invasive tests done at scheduled visits and typically take only a few minutes. The study team will guide you through the process and answer any questions.
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During the study, you will wear a small heart monitor called a Holter on four separate occasions. This device continuously records your heart’s electrical activity over a 24-hour period. A member of the study team will place the Holter and remove it after each monitoring period.
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Blood samples help the research team monitor your general health and learn how the investigational medication is processed by the body. Samples are collected by trained staff during scheduled visits, and the study team will explain when blood draws occur and what they are used to evaluate.
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Check-ins are scheduled conversations with the study team to review how you’re feeling, discuss any changes in your health or medications, and answer questions. These visits are also a chance to confirm next steps and ensure you feel supported throughout the study.
No commitment required: A member of the research team will walk you through what to expect before any decisions are made. This study does not require any commitment until you have spoken with clinical research personnel, reviewed the informed consent form, and had all your questions answered.
Is This Study Right for Me?
Wave II may be a good fit for people who:
Have been diagnosed with Long QT Syndrome Type 2 (LQTS2), including genetic testing
Have QT prolongation greater than 480 milliseconds (ms) on ECG
Are willing to take part in study visits and heart monitoring while taking the investigational medication
Are interested in contributing to research that may help the broader LQTS community
Only a study doctor can determine whether someone is eligible to participate.
If you're curious, the first step is simply to reach out and learn more.
Study Visit Overview
While each person’s experience is unique, participation generally includes:
Initial Conversations and Screening
1
Getting to know you, your medical history, and whether the study may be appropriate.
Baseline Assessments
2
Understanding your natural heart rhythm before beginning any investigational medication.
Study Participation Period
3
Participation includes a defined number of on-site study visits over several months. Some visits may be longer than others and may involve an overnight stay at the study site. Some study visits may also be arranged to be completed at your home.
Follow-up
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Staying connected with the study team so researchers can understand your experience over time. This process allows researchers to safely and respectfully evaluate the investigational medication.
Your Questions, Answered
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A clinical study helps researchers understand whether an investigational medication is safe and how it works in people. Today's approved medications all exist because volunteers participated in studies like this one.
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Only people living with LQTS2 can help researchers learn how investigational medications may work in this specific condition.
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There is no cost to join a clinical study. Study-related tests, procedures, and any travel required are provided at no charge to the participant.
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Participation lasts up to one year, depending on your screening and follow-up visits. A member of the study team can provide full details.
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Your personal information is kept confidential in accordance with clinical research regulations. A member of the study team can provide more details.
Learn More
To read the full study listing, including detailed eligibility criteria and site information:
ClinicalTrials.gov (NCT07277582)
The safety and efficacy of THRV-1268 have not yet been established. THRV-1268 has not been approved for commercial use by any regulatory authority (e.g. the FDA in the United States or Health Canada in Canada).
Working Together for the LQTS Community
Wave II is made possible by people who choose to take part in research, partnering with the clinical and research professionals at participating study sites, and the study sponsor.
Your interest, your time, and your voice help move LQTS science forward — today and for future generations.