A Phase 2/3, Two-part, Dose-ranging, Adaptive Study to Evaluate Efficacy and Safety of THRV-1268 in Participants Diagnosed With Long QT Syndrome Type 2 (LQTS 2) and Type 3 (LQTS 3)

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.

Start Date07 Mar 2026

Sponsor / Collaborator

Thryv Therapeutics, Inc.

NCT07186946

/ CompletedPhase 1

A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Comparative Bioavailability (Unblinded) of THRV-1268 in Health Obese Adult Participants

A research study that involves the use of an investigational drug called THRV-1268. The main purpose is to measure the safety (whether it causes any side effects) and tolerability (if it does cause any side effects, how well your body is able to handle them) in healthy obese adults. This study will also look at how the drug moves through the body, is absorbed, distributed, metabolized and eliminated.

Start Date15 Sep 2025

Sponsor / Collaborator

Thryv Therapeutics, Inc.

NCT06507839

/ CompletedPhase 1

A First-in-Human, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study To Assess the Safety, Tolerability, Pharmacokinetics, and Food Effect of Thrv-1268 in Healthy Adult Subjects

This is a single-center, randomized, double-blind, placebo-controlled study to be conducted in 2 parts: single ascending dose (SAD) incorporating a food effect arm and multiple ascending dose (MAD). Potential participants for each part will undergo screening procedures within 28 days of enrollment.

Start Date15 May 2024

Sponsor / Collaborator

Thryv Therapeutics, Inc.

100 Clinical Results associated with LQT-1268

100 Translational Medicine associated with LQT-1268

100 Patents (Medical) associated with LQT-1268

News (Medical) associated with LQT-1268

16 Sep 2026

·thryvtrx.com

Thryv Announces JACC: Heart Failure Publication of Converging Human Genetic, Preclinical, and Clinical Evidence Supporting Phase 2a Development of Lead SGK1 Inhibitor THRV-1268 in Heart Failure

THRV-1268 Maintained a Near-Normal Ejection Fraction and Outperformed Empagliflozin Monotherapy in a Validated Model of Heart Failure; Phase 1 Studies Demonstrated Favorable Safety Profile and QTcF Shortening Exclusive worldwide license adds a structurally distinct SGK1 inhibitor scaffold to Thryv's portfolio, with claims spanning neurodegenerative and cardiovascular indications, creating a purpose-built path toward Parkinson's disease, Alzheimer's disease, and related disorders alongside the company's advancing cardiac programs. Thryv Therapeutics Inc., a clinical-stage biotechnology company advancing novel serum glucocorticoid inducible kinase 1 (SGK1) inhibitors for inherited and acquired cardiometabolic diseases, today announced its participation in three upcoming prominent investor conferences in New York City. Patient dosing has commenced in the Phase 2/3 Wave II clinical study evaluating THRV-1268 in patients with genetically confirmed Long QT Syndrome Type 2, and the U.S. Food and Drug Administration (FDA) granted Fast Track Designation to THRV-1268 for the treatment of Long QT Syndrome Type 2 and Type 3. Thryv Therapeutics Inc., a clinical-stage biotechnology company advancing novel serum glucocorticoid inducible kinase 1 (SGK1) inhibitors for inherited cardiac arrhythmias, cardiometabolic diseases, and cardiomyopathies, today announced the initiation of the Wave II clinical study, a pivotal Phase 2/3 clinical research study in adults diagnosed with Long QT Syndrome Type 2 (LQTS2). Thryv Therapeutics Inc., a clinical-stage biotechnology company advancing novel inhibitors of serum glucocorticoid inducible kinase 1 (SGK1) for inherited cardiac arrhythmias and cardiometabolic diseases, today announced encouraging results from a recently completed Phase 1 clinical study evaluating THRV-1268 in obese participants (NCT07186946). Thryv Therapeutics Inc., a clinical-stage biotechnology company advancing a series of novel serum glucocorticoid inducible kinase 1 (SGK1) inhibitors for inherited cardiac arrhythmias, cardiometabolic diseases, and cardiomyopathies, today announced the appointment of Matt Killeen, PhD, as Chief Business Officer (CBO). Thryv Therapeutics Inc., a clinical-stage biotechnology company advancing a series of novel serum glucocorticoid inducible kinase 1 (SGK1) inhibitors for inherited cardiac arrhythmias, cardiometabolic diseases, and cardiomyopathies, today announced the launch of myQTwave, a first-of-its-kind, fully remote, app-based observational study designed to capture the lived experience of people with Long QT Syndrome (LQTS). Thryv Therapeutics Inc., a clinical-stage biotechnology company advancing a series of novel serum glucocorticoid inducible kinase 1 (SGK1) inhibitors for inherited cardiac arrhythmias, cardiometabolic diseases, and cardiomyopathies, today announced the appointment of Amy Rudolph, PhD, to its Board of Directors. Thryv Therapeutics Inc., a clinical-stage biotechnology company advancing a series of novel serum glucocorticoid inducible kinase 1 (SGK1) inhibitors for inherited cardiac arrhythmias, cardiometabolic diseases, and cardiomyopathies, today announced that new preclinical data will be presented at the American Heart Association’s Scientific Sessions 2025, taking place November 8–10 in New Orleans, Louisiana. Thryv Therapeutics Inc., a clinical-stage biotechnology company advancing a series of novel serum glucocorticoid inducible kinase 1 (SGK1) inhibitors for inherited cardiac arrhythmias, cardiometabolic diseases, and cardiomyopathies, today announced its participation in several prominent healthcare investor conferences this fall, where the company will provide updates on its pipeline and progress in precision cardiovascular medicine. Thryv Therapeutics Inc., a clinical-stage biotechnology company pioneering novel serum glucocorticoid inducible kinase 1 (SGK1) inhibitors for cardiovascular diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for its lead compound, THRV-1268. This clearance enables Thryv to initiate the Phase 2/3 WAVE II clinical study in Long QT Syndrome (LQTS) Type 2. Thryv Therapeutics Inc., a clinical-stage biotechnology company advancing a series of novel serum glucocorticoid inducible kinase 1 (SGK1) inhibitors for cardiovascular diseases, today announced the presentation of preclinical results demonstrating improvements in adverse cardiac remodeling beyond empagliflozin (EMPA) by reducing inflammation and fibrosis mechanisms in heart failure. Thryv Therapeutics Inc., a clinical-stage biotechnology company, today announced that Dr. Saumya Das will present compelling new preclinical results on its lead compound, THRV-1268, at the upcoming European Society of Cardiology (ESC) Congress 2025, taking place August 29 – September 1, 2025, in Madrid, Spain. Thryv Therapeutics Inc., a clinical-stage biotechnology company advancing a series of novel serum glucocorticoid inducible kinase 1 (SGK1) inhibitors for cardiovascular diseases, today announced its participation in two upcoming prominent investor conferences in New York City. Thryv Therapeutics Inc., a clinical-stage biotechnology company pioneering novel therapies for cardiovascular diseases, is pleased to announce its participation in the 2025 Heart Rhythm Society (HRS) Annual Meeting. The conference will be held at the San Diego Convention Center from April 24-27, 2025. Thryv Therapeutics Inc., a clinical-stage biotechnology company pioneering novel therapies for cardiovascular diseases, is pleased to announce its participation in the 2025 Piper Sandler Virtual Cardio Day on April 1, 2025. Thryv Therapeutics Inc., a clinical-stage biotechnology company pioneering novel therapies for cardiovascular diseases, is pleased to announce its participation in the 2025 Leerink Partners Global Healthcare Conference. The event is set to take place from March 10-12, 2025, at the W Hotel South Beach in Miami, Florida. Thryv Therapeutics Inc., a clinical-stage biotechnology company pioneering novel therapies for cardiovascular diseases, is pleased to announce its attendance at the 43rd Annual J.P. Morgan Healthcare Conference, taking place January 13-16, 2025, in San Francisco, CA. Thryv Therapeutics Inc., a clinical-stage biotechnology company pioneering novel therapies for cardiovascular diseases, is pleased to announce the appointment of Amy Sehnert, MD, as Chief Medical Officer (CMO).

Phase 1Executive ChangeFast Track

15 Sep 2026

·www.prnewswire.com

Thryv Therapeutics Announces JACC: Heart Failure Publication of Converging Human Genetic, Preclinical, and Clinical Evidence Supporting Phase 2a Development of Lead SGK1 Inhibitor THRV-1268 in Heart Failure

THRV-1268 Maintained a Near-Normal Ejection Fraction and Outperformed Empagliflozin Monotherapy in a Validated Model of Heart Failure; Phase 1 Studies Demonstrated Favorable Safety Profile and QTcF Shortening SAN FRANCISCO, Sept. 15, 2026 /PRNewswire/ -- Thryv Therapeutics Inc. ("Thryv"), a clinical-stage biopharmaceutical company developing selective SGK1 inhibitors for inherited cardiac arrhythmias, cardiometabolic diseases, and cardiomyopathies, today announced the publication of its new study in JACC: Heart Failure, presenting human genetic, preclinical, and clinical evidence supporting SGK1 inhibition as a novel therapeutic approach for heart failure with reduced ejection fraction (HFrEF). Despite advances in guideline-directed medical therapy (GDMT), substantial residual risk persists in HFrEF, with high rates of worsening heart failure, hospitalization, and death. Contemporary data show that approximately 40% of recently hospitalized patients prescribed quadruple GDMT die or are hospitalized for heart failure within 12 months1. Approximately half of patients with advanced heart failure also have QTc prolongation, a biomarker associated with increased arrhythmia susceptibility and worse outcomes, including higher mortality at 6 months2. The publication, titled "Genetic, Preclinical, and Clinical Evidence Supports SGK1 Inhibition in Heart Failure," describes an integrated body of evidence supporting SGK1 as a genetically validated cardiometabolic therapeutic target and THRV-1268 as a potential first-in-class therapy to address the electrical and structural remodeling that drive disease in patients living with HFrEF. Key findings include: Human genetic data strongly support SGK1 as a therapeutic target in heart failure. Genetic studies connect SGK1 expression to heart failure risk. Notably, people who naturally carry a genetic variant that lowers SGK1 expression in cardiac tissue have a lower risk of developing heart failure. In diseased human hearts, SGK1 levels are consistently elevated across multiple types of cardiomyopathies. THRV-1268 maintained cardiac function, alone and with empagliflozin, in a validated animal model of heart failure. Treatment preserved systolic function through day 56, with greater and more durable efficacy than empagliflozin monotherapy. THRV-1268 also improved multiple measures of adverse remodeling, reduced natriuretic peptide expression, and reversed pathological inflammatory, fibrotic, and metabolic gene-expression pathways in the heart. In combination with empagliflozin, THRV-1268 maintained a near-normal ejection fraction and attenuated cardiac remodeling, supporting its potential to complement existing standard-of-care therapy. THRV-1268 demonstrated favorable clinical safety and QTcF shortening in individuals with obesity. Across two randomized, double-blind, placebo-controlled Phase 1 studies (NCT06507839, NCT07186946), THRV-1268 was hemodynamically neutral, and well tolerated. In the second study statistically significant QTcF shortening, consistent with cardiac target engagement, was observed. "SGK1 sits at the intersection of electrical remodeling and structural remodeling, key drivers of residual risk for lethal arrhythmias and pump failure that remain inadequately addressed in heart failure patients," said Amy Sehnert, MD, FACC, Chief Medical Officer of Thryv Therapeutics and co-senior author of the publication. "The convergence of human genetic data with the targeted actions of SGK1 inhibition on reversing metabolic, inflammatory, and fibrosis cardiac disease biology seen in HF, in addition to QTc reduction, distinguishes this mechanism from conventional therapies and provides strong rationale to advance THRV-1268 into Phase 2 clinical development." The findings support the near-term initiation of ASPIRE-HF (Addressing SGK1-driven Prolonged QT and Impaired REmodeling in Heart Failure), a Phase 2a study of THRV-1268 in patients with symptomatic HFrEF and QTc prolongation who remain at risk of potentially lethal arrhythmias and worsening heart failure despite current therapies. The study is designed to evaluate the safety and PK of THRV-1268 and its effects on arrhythmic risk, cardiac remodeling, and established heart failure biomarkers. The article is open access and available at . About SGK1 Serum and glucocorticoid-regulated kinase 1 (SGK1) is a genetically validated cardiometabolic disease node, implicated in key drivers of residual risk in heart failure and cardiomyopathies, including electrical and structural remodeling and pump failure. As a stress-responsive kinase, SGK1 acts across four disease domains relevant to heart failure: myocardial metabolic stress, inflammation, fibrosis, and electrical remodeling. Therapeutic translation of SGK1 biology has historically been limited by the lack of potent, selective inhibitors, a gap Thryv's proprietary SGK1 inhibitor portfolio was built to address. About THRV-1268 THRV-1268 is an oral, selective SGK1 inhibitor and Thryv Therapeutics' lead clinical candidate. Across two randomized, double-blind, placebo-controlled Phase 1 studies, THRV-1268 was well tolerated, showed rapid absorption and dose-related exposure, and produced statistically significant QTcF shortening in individuals with obesity, consistent with cardiac target engagement. THRV-1268 is currently being evaluated in WAVE II, a Phase 2/3 clinical study in patients with Long QT Syndrome Type 2. About ASPIRE-HF ASPIRE-HF is a Phase 2a study of THRV-1268 in adults with HFrEF and QTc prolongation, expected to open for enrollment in Q4 2026. The study will initially enroll at sites in Australia, with potential expansion to additional regions in 2027. Key efficacy endpoints include change from baseline to week 24 in QTcF, NT-proBNP and LVEF with a pre-specified early efficacy evaluation of QTcF change and change in NT-proBNP at week 6. About Thryv Therapeutics Thryv Therapeutics Inc. is a clinical-stage biopharmaceutical company developing a proprietary portfolio of highly potent and selective SGK1 inhibitors for cardiometabolic and CNS diseases of high unmet need. Thryv Therapeutics is headquartered in Montreal, Quebec. For more information, please visit . 1. Greene SJ, et al. JAMA Cardiol. 2026;11(3):293-297. doi:10.1001/jamacardio.2025.5339 2. Vrtovec B, et al. Circulation. 2003;107(13):1764-1769. doi:10.1161/01.CIR.0000057980.84624.95 SOURCE Thryv Therapeutics Inc. 21% more press release views with Request a Demo

Phase 1Clinical ResultPhase 2

04 Sep 2026

·allsci.com

Thryv expands SGK1 platform into neurodegeneration with Spanish academic license

Montréal-based Thryv Therapeutics Inc. has licensed an exclusive, worldwide patent and know-how rights to a structurally distinct class of SGK1 inhibitors from Spain's Consejo Superior de Investigaciones Científicas (CSIC), the Universidad Autónoma de Madrid (UAM), and the Fundación de la Universidad Autónoma de Madrid (FUAM), extending its serum- and glucocorticoid-regulated kinase 1 (SGK1) inhibitor platform into Parkinson's disease, Alzheimer's disease, and related neurodegenerative disorders. The agreement, effective July 1, 2026, grants Thryv rights across all fields of use in all territories, with sublicensing rights. Financial terms were not disclosed. The licensed series represents a chemically independent scaffold from the compounds underpinning Thryv's existing cardiovascular pipeline — a distinction the company said gives it the ability to optimize chemistry specifically for central nervous system penetration rather than adapting compounds designed for cardiac indications. No development candidate from the CSIC/UAM series has yet been nominated; Thryv said it is targeting a first candidate nomination in 2027. The CSIC/UAM chemistry originated from a collaboration spanning medicinal chemistry, cardiovascular pharmacology, neurobiology, and vascular pharmacology groups across the two institutions. The patent claims cover both neurodegenerative and cardiovascular indications, giving Thryv broad optionality from a single transaction without field-of-use restrictions — a structure that is unusual for academic licenses at this stage, which are more commonly limited to a defined therapeutic area. The deal arrives as Thryv's lead asset, THRV-1268, an orally available selective SGK1 inhibitor, is advancing on two fronts. The company commenced patient dosing in Wave II, a multicenter Phase II/III study in genetically confirmed Long QT Syndrome (LQTS) Type 2, in April 2026 and received FDA Fast Track Designation for THRV-1268 in that setting. A Phase IIa study in heart failure with reduced ejection fraction, ASPIRE-HF, is planned to follow. Thryv received FDA IND clearance for THRV-1268 in heart failure and atrial fibrillation in September 2025. The CSIC/UAM license is Thryv's second academic in-license of an SGK1 scaffold. The company was founded on SGK1 inhibitor chemistry and built its cardiovascular pipeline through independent medicinal chemistry on that original series, supported by a library of more than 500 synthesized analogs. Adding a second independent chemotype allows parallel development tracks without the two programs competing for the same chemical optimization resources. No other company currently has an SGK1 inhibitor in clinical trials for cardiovascular or neurodegenerative disease based on publicly available records. Spot something wrong? Report an issue with this article

Fast TrackLicense out/inPhase 2IND

100 Deals associated with LQT-1268

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Long Qt Syndrome 2	Phase 3	United States	Thryv Therapeutics, Inc.	07 Mar 2026
Long QT Syndrome Type 3	Phase 3	United States	Thryv Therapeutics, Inc.	07 Mar 2026
Long Qt Syndrome 3	Phase 2	United States	Thryv Therapeutics, Inc.	-
Heart Failure	Phase 1	United States	Thryv Therapeutics, Inc.	15 Sep 2025
Atrial Fibrillation	Phase 1	Canada	Thryv Therapeutics, Inc.	15 May 2024
Heart failure with normal ejection fraction	Phase 1	Canada	Thryv Therapeutics, Inc.	-

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