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Evaluation of the Efficacy and Safety of THRV-1268 in Participants With Long QT Syndrome Type 2 (LQTS2) and Type 3 (LQTS3)

Study acronym: Wave II
StatusRecruiting
PhasePhase 2/3
Started
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Record History

See every version on ClinicalTrials.gov ↗

  1. Enrollment increased: 64 → 84 participants Show 4 more changesShow less
    • Eligibility criteria expanded, about 92 words
    • Secondary endpoints: details revised at 2 of 4 entries
    • Site details revised at 1 of 9 sites
    • Study title expanded, about 6 words
  2. Trial sites expanded: 6 → 9 locationsv14
  3. Start date changed from estimate of Mar 31, 2026 to Mar 7, 2026v13
  4. Site details revised at 1 of 6 sitesv12
  5. Site details revised at 1 of 6 sitesv11
Show 9 earlier versionsHide 9 earlier versions
  1. Site details revised at 1 of 6 sitesv10
  2. Start date: Jan 31, 2026 to Mar 31, 2026
    • Site details revised at 1 of 6 sites
    v9
  3. Study sites: 8 to 6v8
  4. Site details revised at 1 of 8 sitesv7
  5. Re-verified, no change to tracked fieldsv6
  6. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 7 to 8
    v5
  7. Study sites: 4 to 7v4
  8. Study sites: 0 to 4v3
  9. Primary endpoints revised (2)
    • Study title shortened, about 2 words
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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) and Long QT Syndrome Type 3 (LQTS 3). 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 twice daily at two dose levels for 6 weeks (Part A) or be randomly assigned to a dose group for 6 weeks (Part B - cohort 1) 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 and LQTS 3.
Trial Details
NCT Number NCT07277582
Lead Sponsor Thryv Therapeutics, Inc.
Conditions
(from sponsor)		 Long QT Syndrome (LQTS) 2
Related terms Long QT Syndrome
Enrollment 84 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov