NCT07448038From ClinicalTrials.govRecruiting

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

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

Atherosclerosis

At a glance

Phase: Phase 2
Study type: Interventional
Sponsor: Genentech, Inc.
Enrolment target: 162
Started: 5 June 2026
Main results due: 31 January 2028
Study sites: 25
Registry updated: 29 September 2026

Can you take part?

Aged 18 years and over.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility 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 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

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(25)

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

Showing 25 of 25 sites. 25 of the 25 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07448038. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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