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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Atherosclerosis

In brief

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.

Key facts

Study ID

NCT07448038

Run by

Genentech, Inc.

People needed

162

Starts

2026-06-05

Expected to finish

2028-02-28

Last updated by the study team

2026-07-31

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Cardiovascular Research Foundation of Southern California — Beverly Hills, California, United States (enrolling)
• National Heart Institute — Beverly Hills, California, United States (enrolling)
• Amnova Clinical Research — Irvine, California, United States (enrolling)
• Alliance Clinical West Hills (Focus Clinical Research) — West Hills, California, United States (enrolling)
• Inpatient Research Clinic (Las Palmas Medical Research Center) — Miami Lakes, Florida, United States (enrolling)
• Asha Clinical Research-Munster,Llc — Hammond, Indiana, United States (enrolling)
• Profound Research LLC at Cardiology and Vascular Associates - CAVA — Bloomfield Hills, Michigan, United States (enrolling)
• Profound Research LLC at Millenium Cardiology — Farmington Hills, Michigan, United States (enrolling)
• Ahmed Arif Medical Research Center (AA MRC LLC ) — Flint, Michigan, United States (enrolling)
• DiGiovanna Inst for Med Ed&Res — North Massapequa, New York, United States (enrolling)
• Preferred Primary Care Physicians, Inc — Pittsburgh, Pennsylvania, United States (enrolling)
• Southwest Family Medicine Associates — Dallas, Texas, United States (enrolling)
• East Texas Cardiology PA — Houston, Texas, United States (enrolling)
• Cardiovascular Specialists of Willowbrook — Houston, Texas, United States (enrolling)
• Eastside Research Associates, LLC dba Era Health Research — Redmond, Washington, United States (enrolling)
• Cardio Health Clinical Trials — Hamilton, Ontario, Canada (enrolling)

Full record on ClinicalTrials.gov

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