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Clinical Trials in Canada / NCT07448038
Recruiting Phase 2

A Study to Evaluate the Efficacy, Safety, Pharmacodynamics (PD), and Pharmacokinetics (PK) of Selnoflast in Reducing Vascular Inflammation in Participants With Atherosclerosis at Risk for Major Adverse Cardiac Events

NCT07448038 · tracked via the Priya Life Science Canada tracker
Phase
Phase 2
Started
2026-06-05
Last updated
2026-09-03

Condition(s) studied

Atherosclerosis

Investigational drug(s) / intervention(s)

SelnoflastPlacebo

Selnoflast: Selnoflast will be administered as per the schedule specified in the respective arm.

Placebo: Placebo will be administered as per the schedule specified in the respective arm.

Study summary

The main purpose of the study is to evaluate the efficacy of selnoflast compared with placebo in participants with atherosclerosis, at high-risk for major adverse cardiovascular event (MACE), who are currently on standard-of-care (SOC) therapy.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Confirmed evidence of atherosclerosis * Left or right carotid TBR ≥ 1.8 or aorta TBR ≥ 2.0 on centrally-assessed 18F-fluorodeoxyglucose-Positron Emission Tomography (18F-FDG-PET) scan * Stable treatment of atherosclerosis through the use of SOC medications or revascularization * QT interval corrected through use of Fridericia's formula (QTcF) of ≤ 450 milliseconds (ms) in men and ≤ 470 ms in women by a single 12-lead electrocardiogram (ECG) recording Exclusion Criteria: * Individuals with Class III and IV heart failure * Uncontrolled cardiac arrhythmia * Uncontrolled hypertension * Suspected or known immunocompromised state * Planned procedure or surgery during the study and any major surgery within 90 days prior to screening Visit 1 * History of malignancy within 5 years prior to screening, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or Stage I uterine cancer * Positive test results for hepatitis B (HBV) infection at screening * Positive hepatitis C virus (HCV) antibody test at screening * Positive human immunodeficiency virus (HIV) test at screening * Estimated glomerular filtration rate \<50 mL/min/1.73 m² as calculated through use of the Chronic Kidney Disease Epidemiology Collaboration equation, at the time of screening. * Treatment with any live vaccine within 28 days prior to the first dose of study drug until the end of the study * Treatment with other non-live vaccines within 14 days prior to the first dose of study drug until the end of the study

Primary outcome measure(s)

Trial sites (24)

FacilityCityRegionStatus
Cardiovascular Research Foundation of Southern California Beverly Hills California Recruiting
National Heart Institute Beverly Hills California Recruiting
Amnova Clinical Research Irvine California Recruiting
NorthBay Clinical Research Santa Rosa California Recruiting
Alliance Clinical West Hills (Focus Clinical Research) West Hills California Recruiting
Yale University School of Medicine Yale-New Haven Hospital (YNHH) - Smilow Cancer Hospital New Haven Connecticut Recruiting
Inpatient Research Clinic (Las Palmas Medical Research Center) Miami Lakes Florida Recruiting
Asha Clinical Research-Munster,Llc Hammond Indiana Recruiting
Profound Research LLC at Cardiology and Vascular Associates - CAVA Bloomfield Hills Michigan Recruiting
Profound Research LLC at Millenium Cardiology Farmington Hills Michigan Recruiting
Ahmed Arif Medical Research Center (AA MRC LLC ) Flint Michigan Recruiting
University of Minnesota Minneapolis Minnesota Recruiting
Washington University, School of Medicine St Louis Missouri Recruiting
University of Nebraska Medical Center Omaha Nebraska Recruiting
DiGiovanna Inst for Med Ed&Res North Massapequa New York Recruiting
UNC Heart & Vascular Chapel Hill North Carolina Recruiting
Preferred Primary Care Physicians, Inc Pittsburgh Pennsylvania Recruiting
Vanderbilt University School of Medicine (VUSM) - Vanderbilt Translational and Clinical Cardiovascular Research Center (VTRACC) Nashville Tennessee Recruiting
Southwest Family Medicine Associates Dallas Texas Recruiting
East Texas Cardiology PA Houston Texas Recruiting
Cardiovascular Specialists of Willowbrook Houston Texas Recruiting
UT Health San Antonio San Antonio Texas Recruiting
Eastside Research Associates, LLC dba Era Health Research Redmond Washington Recruiting
Cardio Health Clinical Trials Hamilton Ontario Recruiting

More Genentech, Inc. trials in Canada

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07448038 on ClinicalTrials.gov ↗ ← All trials in Canada