Actively Recruiting
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
Led by Genentech, Inc. · Updated on 2026-05-11
162
Participants Needed
6
Research Sites
89 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 61.8 or aorta TBR 62.0 on centrally-assessed 18F-FDG-PET scan
- Stable treatment of atherosclerosis through use of standard-of-care medications or revascularization
- QTcF interval 450 ms in men and 470 ms in women by single 12-lead ECG
You will not qualify if you...
- Individuals with Class III and IV heart failure
- Uncontrolled cardiac arrhythmia
- Uncontrolled hypertension
- Suspected or known immunocompromised state
- Planned procedure or surgery during study or major surgery within 90 days prior to screening
- History of malignancy within 5 years prior to screening except treated carcinoma in situ of cervix, non-melanoma skin carcinoma, or Stage I uterine cancer
- Positive hepatitis B test at screening
- Positive hepatitis C virus antibody test at screening
- Positive HIV test at screening
- Treatment with any live vaccine within 28 days prior to first study drug dose until study end
- Treatment with other non-live vaccines within 14 days prior to first study drug dose until study end
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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/
CONTACT
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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