TerminatedPhase 1/2

Study of LQT-1213 on QTc-induced Prolongation in Healthy Adult Subjects (Part1) and on Congenital Long QT in Patients Diagnosed With Type 2 or 3 Long QT Syndrome (Part 2).

Stopped: Advancing an alternative SGK1 inhibitor.

United States42 participantsStarted 2023-03-12

Plain-language summary

Part 1: This is a Phase 1b, randomized, double-blind, crossover, dose escalation, placebo-controlled study to evaluate the effect of oral LQT-1213 on dofetilide-induced QTc prolongation in healthy adult subjects. This is a 2-treatment, 2-period crossover study with approximately up to 28 healthy subjects, with screening procedures within 28 days of enrolment. Part 2: This is a Phase 2a, single-blind, placebo run-in, multiple-dose safety study to evaluate the safety, tolerability, and PK of LQT-1213 in patients diagnosed with LQT2 or LQT3. Up to 12 participants with LQT2 and up to 12 participants with LQT3 will be recruited.

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Male and female subjects between 18 and 60 years of age (inclusive) at Screening.
. Not previously enrolled in a clinical study with LQT-1213.
. Normal general health.
. Body mass index within 18.0 to 32.0 kg/m2, inclusively at Screening.
. Female subjects of nonchildbearing potential must be either surgically sterile (hysterectomy, bilateral tubal ligation, salpingectomy, and/or bilateral oophorectomy at least 26 weeks before Screening) or postmenopausal, defined as spontaneous amenorrhea for at least 2 years, with follicle-stimulating hormone in the postmenopausal range at Screening, based on the central laboratory's ranges.
. Female subjects of childbearing potential (ie, ovulating, premenopausal, and not surgically sterile) must use a highly effective contraceptive regimen during their participation in the study and for 30 days after the last administration of study drug. Highly effective contraceptive methods are defined as those with \<1% failure rate per year. Acceptable methods of contraception for female subjects enrolled in the study include the following:

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Part 1: Pharmacodynamics: By-time Point Analysis for QTc on LQT-1213 Versus Placebo

Timeframe: 2.0 hours after administration of study treatment on Day 4.

Part 1: Pharmacodynamics: By-time Point Analysis for QTc on LQT-1213 Versus Placebo

Timeframe: 2.5 hours after administration of study treatment on Day 4

Part 1: Pharmacodynamics: By-time Point Analysis for QTc on LQT-1213 Versus Placebo

Timeframe: 3.0 hours after administration of study treatment on Day 4

Part 1: Pharmacodynamics: By-time Point Analysis for QTc on LQT-1213 Versus Placebo

Timeframe: 3.5 hours after administration of study treatment on Day 4

Part 1: Pharmacodynamics: By-time Point Analysis for QTc on LQT-1213 Versus Placebo

Timeframe: 4.0 hours after administration of study treatment on Day 4

Part 1: Pharmacodynamics: By-time Point Analysis for QTc on LQT-1213 Versus Placebo

Timeframe: 2.0 hours after administration of study treatment on Day 6

Trial details

NCT IDNCT05906732

SponsorThryv Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-05-31

Results submitted2025-05-29

View on ClinicalTrials.gov More Long QT Syndrome trials

Plain-language summary

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Male and female subjects between 18 and 60 years of age (inclusive) at Screening.
. Not previously enrolled in a clinical study with LQT-1213.
. Normal general health.
. Body mass index within 18.0 to 32.0 kg/m2, inclusively at Screening.
. Female subjects of nonchildbearing potential must be either surgically sterile (hysterectomy, bilateral tubal ligation, salpingectomy, and/or bilateral oophorectomy at least 26 weeks before Screening) or postmenopausal, defined as spontaneous amenorrhea for at least 2 years, with follicle-stimulating hormone in the postmenopausal range at Screening, based on the central laboratory's ranges.
. Female subjects of childbearing potential (ie, ovulating, premenopausal, and not surgically sterile) must use a highly effective contraceptive regimen during their participation in the study and for 30 days after the last administration of study drug. Highly effective contraceptive methods are defined as those with \<1% failure rate per year. Acceptable methods of contraception for female subjects enrolled in the study include the following: