A Phase 2 interventional study of Selnoflast and Placebo in Atherosclerosis, sponsored by Genentech, Inc.. Recruiting at 25 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by Genentech, Inc. · Phase 2, Interventional, and Treatment
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.
Exclusion Criteria:
Participants will receive selnoflast, orally (PO), twice a day (BID) for 12 weeks.
Drug: Selnoflast
Participants will receive placebo, PO, BID for 12 weeks.
Drug: Placebo
Selnoflast will be administered as per the schedule specified in the respective arm.
Also known as: RO7486967
Placebo will be administered as per the schedule specified in the respective arm.
Change in mdsTBR (Most-diseased Segment TBR [Target-to-background Ratio]) of Index Vessel From Baseline to Week 12 in Participants With Baseline Elevated hsCRP (≥ 2 milligrams per liter [mg/L])
hsCRP=high-sensitivity C-reactive protein.
Time frame: Baseline up to Week 12
Change From Baseline in mdsTBR of Index Vessel at Week 12 in all Participants (hsCRP < 2 mg/L and ≥ 2mg/L)
Time frame: Baseline and Week 12
Change From Baseline in mdsTBR of Carotids at Week 12 in all Participants (hsCRP < 2 mg/L and ≥ 2 mg/L)
Time frame: Baseline and Week 12
Change From Baseline in mdsTBR of Carotids at Week 12 in Participants With Baseline Elevated hsCRP (≥ 2 mg/L)
Time frame: Baseline and Week 12
Change From Baseline in Active Segments TBR and the Whole Vessel TBR of the Index Vessel at Week 12 in all Participants (hsCRP < 2 mg/L and ≥ 2 mg/L)
Time frame: Baseline and Week 12
Change From Baseline in Active Segments TBR and the Whole Vessel TBR of the Index Vessel at Week 12 in Participants With Baseline Elevated hsCRP (≥ 2 mg/L)
Time frame: Baseline and Week 12
Number of Participants With Adverse Events (AEs) and Severity of AEs Determined According to the NCI CTCAE v5.0 Grading Scale
NCI CTCAE v5.0 = National Cancer Institute's Common Terminology Criteria for Adverse Events, Version 5.0.
Time frame: Up to approximately 22 weeks
Plasma Concentration of Selnoflast at Specified Timepoints
Time frame: Up to 12 weeks
Plan to share: Yes — For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
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Genentech, Inc.