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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts 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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Selnoflast 		Participants will receive selnoflast, orally (PO), twice a day (BID) for 12 weeks.
  • Drug: Selnoflast
    Selnoflast will be administered as per the schedule specified in the respective arm.
    Other names:
    • RO7486967
Placebo Comparator
Placebo 		Participants will receive placebo, PO, BID for 12 weeks.
  • Drug: Placebo
    Placebo will be administered as per the schedule specified in the respective arm.

Recruiting Locations

Cardiovascular Research Foundation of Southern California
Beverly Hills, California 90210

National Heart Institute
Beverly Hills, California 90211

Amnova Clinical Research
Irvine, California 92604

NorthBay Clinical Research
Santa Rosa, California 95405

Alliance Clinical West Hills (Focus Clinical Research)
West Hills, California 91307

Yale University School of Medicine Yale-New Haven Hospital (YNHH) - Smilow Cancer Hospital
New Haven, Connecticut 06520-8040

Inpatient Research Clinic (Las Palmas Medical Research Center)
Miami Lakes, Florida 33014

Asha Clinical Research-Munster,Llc
Hammond, Indiana 46324

Profound Research LLC at Cardiology and Vascular Associates - CAVA
Bloomfield Hills, Michigan 48304

Profound Research LLC at Millenium Cardiology
Farmington Hills, Michigan 48334

Ahmed Arif Medical Research Center (AA MRC LLC )
Flint, Michigan 48504

University of Minnesota
Minneapolis, Minnesota 55455

Washington University, School of Medicine
St Louis, Missouri 63110

University of Nebraska Medical Center
Omaha, Nebraska 69198-4130

DiGiovanna Inst for Med Ed&Res
North Massapequa, New York 11758-1802

UNC Heart & Vascular
Chapel Hill, North Carolina 27599-7075

Preferred Primary Care Physicians, Inc
Pittsburgh, Pennsylvania 15243

Vanderbilt University School of Medicine (VUSM) - Vanderbilt Translational and Clinical Cardiovascular Research Center (VTRACC)
Nashville, Tennessee 37203

Southwest Family Medicine Associates
Dallas, Texas 75235

East Texas Cardiology PA
Houston, Texas 77002

Cardiovascular Specialists of Willowbrook
Houston, Texas 77070

UT Health San Antonio
San Antonio, Texas 78229

Eastside Research Associates, LLC dba Era Health Research
Redmond, Washington 98036

More Details

Status
Recruiting
Sponsor
Genentech, Inc.

Study Contact

Reference Study ID Number: GC46102 https://forpatients.roche.com/
888-662-6728
global-roche-genentech-trials@gene.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.