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

This study will test whether selnoflast can lower artery inflammation in people with atherosclerosis who are at high risk for major heart problems and are already on standard treatments.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 162 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Genentech, Inc. (Industry-sponsored)
• Locations: 6 sites (Beverly Hills, California and 5 other locations)
• Trial ID: NCT07448038 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults with confirmed atherosclerosis who are on stable standard-of-care therapy and have elevated arterial inflammation on 18F-FDG-PET (carotid TBR ≥ 1.8 or aorta TBR ≥ 2.0) and meet ECG safety criteria are ideal candidates.

Not a fit: People with advanced (Class III/IV) heart failure, uncontrolled arrhythmias or hypertension, suspected immunocompromise, recent major surgery, recent malignancy, or active hepatitis B are excluded and may not receive benefit from this intervention.

Why it matters

Potential benefit: If successful, selnoflast could reduce arterial inflammation and potentially lower the risk of major cardiovascular events in high-risk atherosclerosis patients.

How similar studies have performed: Other anti-inflammatory approaches for cardiovascular disease (for example, canakinumab and colchicine) have shown reductions in events, but selnoflast represents a newer agent being tested for similar goals.

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
* 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 this trial is running

Beverly Hills, California and 5 other locations

• Cardiovascular Research Foundation of Southern California — Beverly Hills, California, United States (Recruiting)
• Amnova Clinical Research — Irvine, California, United States (Recruiting)
• Alliance Clinical West Hills (Focus Clinical Research) — West Hills, California, United States (Recruiting)
• Asha Clinical Research-Munster,Llc — Hammond, Indiana, United States (Recruiting)
• Preferred Primary Care Physicians, Inc — Pittsburgh, Pennsylvania, United States (Recruiting)
• Eastside Research Associates, LLC dba Era Health Research — Redmond, Washington, United States (Recruiting)

Study contacts

• Study coordinator: Reference Study ID Number: GC46102 https://forpatients.roche.com/

Conditions Atherosclerosis