Back to search results

Selnoflast for Atherosclerosis and Heart Event Risk

This study is testing a drug called selnoflast to see if it can reduce inflammation in blood vessels for people with atherosclerosis (a condition where plaque builds up inside arteries). You might be able to join if you are between 18 and 80 years old, have confirmed atherosclerosis, and are already receiving standard care for your condition. The study will compare selnoflast to a placebo (an inactive substance) to see if selnoflast can lower a specific inflammation marker called mdsTBR in your blood vessels after 12 weeks. The main goal is to see if selnoflast is effective and safe for people at high risk for major adverse cardiac events (serious heart problems).

Study design
This interventional study plans to enroll 162 participants. It will compare selnoflast to a placebo.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured from baseline up to Week 12.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07448038

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

Recruiting
PHASE2Ages 18–80InterventionalTreatment
Genentech, Inc.
~162 participants
Updated 2026-07-31 on ClinicalTrials.gov
What's tested:SelnoflastPlacebo

At a glance

Recruiting sites
16 of 16 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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])
Measured over Baseline up to Week 12

Conditions

Atherosclerosis

Explore related trials

Atherosclerosis

Where it's being run

16 sites across 9 states
California4
Michigan3
Texas3
Florida1
Indiana1
New York1
Pennsylvania1
Washington1

Study leadership

  • Clinical Trials · STUDY_DIRECTOR · Genentech, Inc.

Who to contact

Reference Study ID Number: GC46102 https://forpatients.roche.com/
[email protected]
888-662-6728
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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 this trial measures

  • 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])Baseline up to Week 12

    hsCRP=high-sensitivity C-reactive protein.