Selnoflast to reduce artery inflammation in people with atherosclerosis at high risk of heart events

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 interventional study compares selnoflast with placebo in people with atherosclerosis who remain at high risk for major adverse cardiovascular events despite standard-of-care therapy. Participants are assigned to receive selnoflast or placebo alongside their usual treatments and are monitored for safety, pharmacokinetics, pharmacodynamics, and effects on vascular inflammation. Inflammation is quantified using centrally read 18F-FDG-PET scans with target-to-background ratio (TBR) thresholds for carotid (≥1.8) or aorta (≥2.0) at baseline and follow-up to measure change. Key exclusions include advanced heart failure, uncontrolled arrhythmia or hypertension, immunocompromised states, recent major surgery, recent cancer, and active hepatitis B.

Why it matters

Who can join: the full rules

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

Where it's running

• 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

Study contacts

• Study coordinator: Reference Study ID Number: GC46102 https://forpatients.roche.com/
• Email: global-roche-genentech-trials@gene.com
• Phone: 888-662-6728

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.