Recruiting
Phase 2

GSK-3 Inhibition

Sponsor:

Hamilton Health Sciences Corporation

Code:

NCT06174220

Conditions

Arrhythmogenic Cardiomyopathy

Arrhythmogenic Right Ventricular Cardiomyopathy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Tideglusib

Placebo

Study Details

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.

Conditions

Arrhythmogenic Cardiomyopathy

Arrhythmogenic Right Ventricular Cardiomyopathy

Study ID

NCT06174220

Start date

Mar 21, 2025

Status verified date

Apr, 2025

Completion date

Jul 1, 2027

Anticipated

Primary completion date

Feb 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Tideglusib

Randomization to Tideglusib 1g po daily or matching placebo

placebo comparator: Placebo

Randomization to matching placebo 1g po daily

Interventions

Tideglusib

Tideglusib 1g po daily

Placebo

Matching placebo 1g po daily

Primary outcome measure

  • PVC burden [ Time Frame: Baseline and 6 months ]

Central Contacts and Locations

Central contacts

Jason Roberts, MD MAS

905-521-2100jason.roberts@phri.ca

Maha Mushtaha

maha.mushtaha@phri.ca

Locations

University of Calgary

Recruiting

Calgary, Alberta, Canada, T2N 2T9

Contacts

Erkan Ilhan

403-210-6047erkan.ilhan@ucalgary.ca

Principal Investigator:

Erkan Ilhan, MD

University of British Columbia

Recruiting

Vancouver, British Columbia, Canada, V6Z 1Y6

Contacts

Thomas Roston

604-682-2344rostonm@alumni.ubc.ca

Principal Investigator:

Thomas M Roston, MD PhD

Victoria Cardiac Arrhythmia Trials Inc.

Recruiting

Victoria, British Columbia, Canada, V8Z 0B9

Contacts

May Woodburn

250-595-0400mwoodburn@catrials.org

Principal Investigator:

Martin van Zyl, MD

NL Health Services

Recruiting

St. John's, Newfoundland and Labrador, Canada, A1B 3V6

Contacts

Stephen Duffett

709-752-4636stephen.duffett@easternhealth.ca

Principal Investigator:

Stephen Duffett, MD

Nova Scotia Health

Recruiting

Halifax, Nova Scotia, Canada, B3H 2Y9

Contacts

Victoria Newman

902-473-5341victoria.newman@nshealth.ca

Principal Investigator:

David Lee, MD

Hamilton General Hospital

Recruiting

Hamilton, Ontario, Canada, L8L 2X2

Contacts

Jeff Healey

905-527-0271jeff.healey@phri.ca

Principal Investigator:

Jeff S Healey, MD

London Health Sciences Centre

Recruiting

London, Ontario, Canada, N6A 5A5

Contacts

Sara El-Richani

519-685-8500lhrp.research@lhsc.on.ca

Principal Investigator:

Habib R Khan, MD

Heart Health Institute Research Inc

Recruiting

Scarborough Village, Ontario, Canada, M1E 4B9

Contacts

Emily Magimaidoss

416-281-9499emagimaidoss@hearthealthinstitute.net

Principal Investigator:

Bhavanesh Makanjee, MD

Montreal Heart Institute

Recruiting

Montreal, Quebec, Canada, H1T 1C8

Contacts

Jeremie Cortial

514-376-3330jeremie.cortial@icm-mhi.org

Principal Investigator:

Julia Cadrin-Tourigny, MD PhD

University Institute of Cardiology and Pneumology of Quebec

Recruiting

Québec, Quebec, Canada, G1V 4G5

Contacts

Dr. Christian Steinberg

418-656-8711christian.steinberg@criucpq.ulaval.ca

Principal Investigator:

Christian Steinberg, MD

More Information

Sponsor

Hamilton Health Sciences Corporation

Last update posted

Mar 12, 2026

Last verified

Apr, 2025

Keywords

  • sudden cardiac death, ventricular cardiomyopathy, genetics, arrhythmia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hamilton Health Sciences Corporation on 2026-03-12.