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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

RecruitingPhase 2

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

Who can join

Ages 18 and older · All sexes

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

About the study

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.

What is being tested

Sponsor: Genentech, Inc. · Participants: 162 · Started: Jun 5, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07448038

Locations in the U.S.

CaliforniaCardiovascular Research Foundation of Southern California, Beverly Hills
National Heart Institute, Beverly Hills
Amnova Clinical Research, Irvine
UCLA Health System - UCLA Cardiovascular Center, Los Angeles
NorthBay Clinical Research, Santa Rosa
Alliance Clinical West Hills (Focus Clinical Research), West Hills
ConnecticutYale University School of Medicine Yale-New Haven Hospital (YNHH) - Smilow Cancer Hospital, New Haven
FloridaInpatient Research Clinic (Las Palmas Medical Research Center), Miami Lakes
IndianaAsha Clinical Research-Munster,Llc, Hammond
MichiganProfound Research LLC at Cardiology and Vascular Associates - CAVA, Bloomfield Hills
Profound Research LLC at Millenium Cardiology, Farmington Hills
Ahmed Arif Medical Research Center (AA MRC LLC ), Flint
MinnesotaUniversity of Minnesota, Minneapolis
MissouriWashington University, School of Medicine, St Louis
NebraskaUniversity of Nebraska Medical Center, Omaha
New YorkDiGiovanna Inst for Med Ed&Res, North Massapequa
North CarolinaUNC Heart & Vascular, Chapel Hill
PennsylvaniaPreferred Primary Care Physicians, Inc, Pittsburgh
TennesseeVanderbilt University School of Medicine (VUSM) - Vanderbilt Translational and Clinical Cardiovascular Research Center (VTRACC), Nashville
TexasSouthwest Family Medicine Associates, Dallas
Cardiovascular Specialists of Willowbrook, Houston
East Texas Cardiology PA, Houston
UT Health San Antonio, San Antonio
WashingtonEastside Research Associates, LLC dba Era Health Research, Redmond

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.