A Phase IIa, Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Efficacy, Safety, Pharmacodynamics, and Pharmacokinetics of Selnoflast in Reducing Vascular Inflammation in Patients With Atherosclerosis at Risk for Major Adverse Cardiac Events

Genentech, Inc.

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

Age range: 18+ years
Sex: All
Healthy volunteers: No

Detailed criteria

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 h…

Interventions

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

Locations (25)

Cardiovascular Research Foundation of Southern California
Beverly Hills, California
National Heart Institute
Beverly Hills, California
Amnova Clinical Research
Irvine, California
UCLA Health System - UCLA Cardiovascular Center
Los Angeles, California
NorthBay Clinical Research
Santa Rosa, California
Alliance Clinical West Hills (Focus Clinical Research)
West Hills, California