Targeted Therapy With Glycogen Synthase Kinase-3 Inhibition for Arrhythmogenic Cardiomyopathy

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Arrhythmogenic Cardiomyopathy, Arrhythmogenic Right Ventricular Cardiomyopathy

In brief

The TaRGET study is a multi-centre, prospective, randomized, double-blind, placebo-controlled trial designed to evaluate the potential therapeutic efficacy of tideglusib, a glycogen synthase kinase-3 β inhibitor, in genotype positive arrhythmogenic cardiomyopathy.

Key facts

Study ID

NCT06174220

Run by

Hamilton Health Sciences Corporation

People needed

120

Starts

2025-03-21

Expected to finish

2027-07-01

Last updated by the study team

2026-03-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• A pathogenic or likely pathogenic desmosomal (PKP2, DSG2, DSC2, DSP, or JUP*) rare variant OR the TMEM43-p.S358L variant
• JUP carriers must be homozygous or compound heterozygous
• Mean ≥ 500 PVCs per 24 hours on a baseline screening 7-day Holter monitor
• Clinical ACM diagnosis or recognition of genetic carrier status for ≥ 6 months prior to screening

You may not qualify if…

• NYHA class IV heart failure
• Ventricular scar secondary to coronary artery disease
• Initiation, cessation, or dose change of a Class I or III anti-arrhythmic drug in the 3 months prior to screening
• Any potentially harmful chronic liver disease
• ALT value > 2X the upper limit of the normal reference range at Screening
• Total bilirubin value greater than the upper limit of the normal reference range at Screening, unless documented Gilbert's syndrome. For individuals with Gilbert's syndrome, total bilirubin value greater than 2-fold the upper limit of the normal reference range at Screening.
• A history of alcohol or illicit substance use disorders
• Regular and long-term use of strong CYP3A4 inhibitors, including clarithromycin, telithromycin, ketoconazole, itraconazole, posaconazole, nefazodone, idinavir and ritonavir
• Serum creatinine > 150 micromole/L or creatinine clearance ≤ 60 mL/min (according to Cockcroft-Gault formula) at Screening
• Pregnant at time of enrollment and women of childbearing age who do not use a highly effective form of contraception
• Males, engaged in sexual relations with a female of child-bearing potential, not using an acceptable contraceptive method if not surgically sterile
• Patients unwilling to provide informed consent or comply with follow-up
• Hypersensitivity to tideglusib or any components of its formulation, including allergy to strawberry
• Concurrent use of drugs metabolized by CYP3A4 with a narrow therapeutic window e.g. warfarin and digoxin

Where it is running

• University of Calgary — Calgary, Alberta, Canada (enrolling)
• University of British Columbia — Vancouver, British Columbia, Canada (enrolling)
• Victoria Cardiac Arrhythmia Trials Inc. — Victoria, British Columbia, Canada (enrolling)
• NL Health Services — St. John's, Newfoundland and Labrador, Canada (enrolling)
• Nova Scotia Health — Halifax, Nova Scotia, Canada (enrolling)
• Hamilton General Hospital — Hamilton, Ontario, Canada (enrolling)
• London Health Sciences Centre — London, Ontario, Canada (enrolling)
• Heart Health Institute Research Inc — Scarborough Village, Ontario, Canada (enrolling)
• Montreal Heart Institute — Montreal, Quebec, Canada (enrolling)
• University Institute of Cardiology and Pneumology of Quebec — Québec, Quebec, Canada (enrolling)
• McGill University Health Centre — Montreal, Quebec, Canada
• Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada
• St. Michael's Hospital — Toronto, Ontario, Canada
• Kingston General Hospital — Kingston, Ontario, Canada
• Hopital du Sacré-Coeur de Montréal — Montreal, Quebec, Canada
• Newmarket Electrophysiologist Research Group 'NERG' — Newmarket, Ontario, Canada
• University of Ottawa Heart Institute — Ottawa, Ontario, Canada

Full record on ClinicalTrials.gov

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