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
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Primary outcome measure(s)
- Change in mdsTBR (Most-diseased Segment TBR [Target-to-background Ratio]) of Index Vessel From Baseline to Week 12 in Participants With Baseline Elevated hsCRP (≥ 2 milligrams per liter [mg/L]) — Baseline up to Week 12
hsCRP=high-sensitivity C-reactive protein.
Trial sites (25)
| Facility | City | Region | Status |
|---|---|---|---|
| Cardiovascular Research Foundation of Southern California | Beverly Hills | California | Recruiting |
| National Heart Institute | Beverly Hills | California | Recruiting |
| Amnova Clinical Research | Irvine | California | Recruiting |
| UCLA Health System - UCLA Cardiovascular Center | Los Angeles | 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 | Lynnwood | Washington | Recruiting |
| Cardio Health Clinical Trials | Hamilton | Ontario | Recruiting |
More Genentech, Inc. trials in the USA
Other trials for the same condition
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 the USA