Recruiting
Phase 2

Selnoflast

Sponsor:

Genentech, Inc.

Code:

NCT07448038

Conditions

Atherosclerosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Selnoflast

Placebo

Study Details

Brief 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.

Conditions

Atherosclerosis

Study ID

NCT07448038

Start date

Jun 5, 2026

Status verified date

Sep, 2026

Completion date

Feb 28, 2028

Anticipated

Primary completion date

Jan 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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
  • Estimated glomerular filtration rate <50 mL/min/1.73 m² as calculated through use of the Chronic Kidney Disease Epidemiology Collaboration equation, at the time of 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

Study Design

Enrollment

162 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Selnoflast

Participants will receive selnoflast, orally (PO), twice a day (BID) for 12 weeks.

placebo comparator: Placebo

Participants will receive placebo, PO, BID for 12 weeks.

Interventions

Selnoflast

Selnoflast will be administered as per the schedule specified in the respective arm.

Placebo

Placebo will be administered as per the schedule specified in the respective arm.

Primary outcome measure

  • 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]) [ Time Frame: Baseline up to Week 12 ]

Central Contacts and Locations

Central contacts

Reference Study ID Number: GC46102 https://forpatients.roche.com/

888-662-6728global-roche-genentech-trials@gene.com

Locations

Cardiovascular Research Foundation of Southern California

Recruiting

Beverly Hills, California, United States, 90210

National Heart Institute

Recruiting

Beverly Hills, California, United States, 90211

Amnova Clinical Research

Recruiting

Irvine, California, United States, 92604

NorthBay Clinical Research

Recruiting

Santa Rosa, California, United States, 95405

Alliance Clinical West Hills (Focus Clinical Research)

Recruiting

West Hills, California, United States, 91307

Yale University School of Medicine Yale-New Haven Hospital (YNHH) - Smilow Cancer Hospital

Recruiting

New Haven, Connecticut, United States, 06520-8040

Inpatient Research Clinic (Las Palmas Medical Research Center)

Recruiting

Miami Lakes, Florida, United States, 33014

Asha Clinical Research-Munster,Llc

Recruiting

Hammond, Indiana, United States, 46324

Profound Research LLC at Cardiology and Vascular Associates - CAVA

Recruiting

Bloomfield Hills, Michigan, United States, 48304

Profound Research LLC at Millenium Cardiology

Recruiting

Farmington Hills, Michigan, United States, 48334

Ahmed Arif Medical Research Center (AA MRC LLC )

Recruiting

Flint, Michigan, United States, 48504

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55455

Washington University, School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

University of Nebraska Medical Center

Recruiting

Omaha, Nebraska, United States, 69198-4130

DiGiovanna Inst for Med Ed&Res

Recruiting

North Massapequa, New York, United States, 11758-1802

UNC Heart & Vascular

Recruiting

Chapel Hill, North Carolina, United States, 27599-7075

Preferred Primary Care Physicians, Inc

Recruiting

Pittsburgh, Pennsylvania, United States, 15243

Vanderbilt University School of Medicine (VUSM) - Vanderbilt Translational and Clinical Cardiovascular Research Center (VTRACC)

Recruiting

Nashville, Tennessee, United States, 37203

Southwest Family Medicine Associates

Recruiting

Dallas, Texas, United States, 75235

East Texas Cardiology PA

Recruiting

Houston, Texas, United States, 77002

Cardiovascular Specialists of Willowbrook

Recruiting

Houston, Texas, United States, 77070

UT Health San Antonio

Recruiting

San Antonio, Texas, United States, 78229

Eastside Research Associates, LLC dba Era Health Research

Recruiting

Redmond, Washington, United States, 98036

Cardio Health Clinical Trials

Recruiting

Hamilton, Ontario, Canada, L8W 3K5

More Information

Sponsor

Genentech, Inc.

Last update posted

Sep 3, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Genentech, Inc. on 2026-09-03.