Back to Trials
NCT07448038PHASE2Recruiting

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

Genentech, Inc.

Start Date

6/5/2026

Completion Date

2/28/2028

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 Criteria

Age Range: 18 years to 80 years

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 * 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

Interventions

DRUG

Selnoflast

DRUG

Placebo

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Atherosclerosis

Locations

Cardiovascular Research Foundation of Southern California

Beverly Hills, California 90210

United States

National Heart Institute

Beverly Hills, California 90211

United States

Amnova Clinical Research

Irvine, California 92604

United States

Alliance Clinical West Hills (Focus Clinical Research)

West Hills, California 91307

United States

Inpatient Research Clinic (Las Palmas Medical Research Center)

Miami Lakes, Florida 33014

United States

Asha Clinical Research-Munster,Llc

Hammond, Indiana 46324

United States

Profound Research LLC at Cardiology and Vascular Associates - CAVA

Bloomfield Hills, Michigan 48304

United States

Profound Research LLC at Millenium Cardiology

Farmington Hills, Michigan 48334

United States

Ahmed Arif Medical Research Center (AA MRC LLC )

Flint, Michigan 48504

United States

DiGiovanna Inst for Med Ed&Res

North Massapequa, New York 11758-1802

United States

Preferred Primary Care Physicians, Inc

Pittsburgh, Pennsylvania 15243

United States

Southwest Family Medicine Associates

Dallas, Texas 75235

United States

East Texas Cardiology PA

Houston, Texas 77002

United States

Cardiovascular Specialists of Willowbrook

Houston, Texas 77070

United States

Eastside Research Associates, LLC dba Era Health Research

Redmond, Washington 98036

United States

Cardio Health Clinical Trials

Hamilton, Ontario L8W 3K5

Canada