Actively Recruiting
A Phase IIa Multicenter Randomized Double-blind Placebo-controlled Study of Selnoflast for Reducing Vascular Inflammation in Patients With Atherosclerosis at Risk for Major Cardiac Events
Led by Genentech, Inc. · Updated on 2026-05-11
162
Participants Needed
6
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of selnoflast compared with a placebo in adults with atherosclerosis who are at high risk for major adverse cardiovascular events (MACE) and are currently receiving standard-of-care therapy. This Phase IIa study aims to assess the efficacy, safety, pharmacodynamics, and pharmacokinetics of selnoflast in reducing vascular inflammation in this patient population. Participants are randomly assigned to receive either selnoflast or a placebo orally twice daily for 12 weeks. The study is double-blinded and placebo-controlled, meaning neither participants nor researchers know who receives the active drug or placebo. The trial is designed to measure changes in vascular inflammation using imaging scans and blood markers. During the study, participants will undergo assessments including PET scans to measure inflammation in blood vessels, blood tests to monitor drug levels and inflammatory markers, and safety evaluations for adverse events. The primary outcome focuses on changes in the target-to-background ratio (TBR) in blood vessels after 12 weeks. Participants are monitored for up to approximately 20 weeks for safety and treatment effects.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed evidence of atherosclerosis
- Left or right carotid TBR ≥ 1.8 or aorta TBR ≥ 2.0 on 18F-FDG-PET scan
- Stable treatment of atherosclerosis with standard-of-care medications or revascularization
- QTcF interval ≤ 450 ms in men and ≤ 470 ms in women by 12-lead ECG
You will not qualify if you...
- Class III or IV heart failure
- Uncontrolled cardiac arrhythmia
- Uncontrolled hypertension
- Known or suspected immunocompromised state
- Planned procedure or surgery during the study
- Major surgery within 90 days before screening
- History of malignancy within 5 years except certain treated cancers
- Positive hepatitis B, hepatitis C, or HIV test at screening
- Treatment with any live vaccine within 28 days before first dose until study end
- Treatment with non-live vaccines within 14 days before first dose until study end
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants receive Selnoflast or placebo orally twice a day for 12 weeks to reduce vascular inflammation.
Regular visits for treatment monitoring during the 12 weeks
Duration - Up to approximately 8 weeks after treatment
Participants are monitored for safety and pharmacokinetics up to approximately 20 weeks after starting treatment.
Visits as needed up to 20 weeks from treatment start
Trial Site Locations
Total: 6 locations
1
Cardiovascular Research Foundation of Southern California
Beverly Hills, California, United States, 90210
Actively Recruiting
2
Amnova Clinical Research
Irvine, California, United States, 92604
Actively Recruiting
3
Alliance Clinical West Hills (Focus Clinical Research)
West Hills, California, United States, 91307
Actively Recruiting
4
Asha Clinical Research-Munster,Llc
Hammond, Indiana, United States, 46324
Actively Recruiting
5
Preferred Primary Care Physicians, Inc
Pittsburgh, Pennsylvania, United States, 15243
Actively Recruiting
6
Eastside Research Associates, LLC dba Era Health Research
Redmond, Washington, United States, 98036
Actively Recruiting
Research Team
R
Reference Study ID Number: GC46102 https://forpatients.roche.com/
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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