A Study to Evaluate the Efficacy, Safety, Pharmacodynamics (PD), and Pharmacokinetics (PK) of Sel… (NCT07448038) | Clinical Trial Compass
RecruitingPhase 2
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
United States162 participantsStarted 2026-04-30
Plain-language summary
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.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
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])
Timeframe: Baseline up to Week 12
Trial details
NCT IDNCT07448038
SponsorGenentech, Inc.
Sponsor typeINDUSTRY
Study typeINTERVENTIONAL
Primary completion2028-01-31
Contact for this trial
Reference Study ID Number: GC46102 https://forpatients.roche.com/