NCT06174220 Targeted Therapy With Glycogen Synthase Kinase-3 Inhibition for Arrhythmogenic Cardiomyopathy
| NCT ID | NCT06174220 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Hamilton Health Sciences Corporation |
| Condition | Arrhythmogenic Cardiomyopathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2025-03-21 |
| Primary Completion | 2027-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 120 participants in total. It began in 2025-03-21 with a primary completion date of 2027-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Contact & Investigator
Jason D Roberts, MD MAS
PRINCIPAL INVESTIGATOR
McMaster University and Population Health Research Institute
Frequently Asked Questions
Who can join the NCT06174220 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Arrhythmogenic Cardiomyopathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06174220 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06174220 currently recruiting?
Yes, NCT06174220 is actively recruiting participants. Contact the research team at jason.roberts@phri.ca for enrollment information.
Where is the NCT06174220 trial being conducted?
This trial is being conducted at Calgary, Canada, Vancouver, Canada, Victoria, Canada, St. John's, Canada and 11 additional locations.
Who is sponsoring the NCT06174220 clinical trial?
NCT06174220 is sponsored by Hamilton Health Sciences Corporation. The principal investigator is Jason D Roberts, MD MAS at McMaster University and Population Health Research Institute. The trial plans to enroll 120 participants.