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

Last updated: May 8, 2026
Sponsor: Genentech, Inc.
Overall Status: Active - Recruiting

Phase

2

Condition

Atherosclerosis

Treatment

Selnoflast

Placebo

Clinical Study ID

NCT07448038
GC46102
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 orrevascularization

  • QT interval corrected through use of Fridericia's formula (QTcF) of ≤ 450milliseconds (ms) in men and ≤ 470 ms in women by a single 12-lead electrocardiogram (ECG) recording

Exclusion

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 daysprior to screening Visit 1

  • History of malignancy within 5 years prior to screening, except for appropriatelytreated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or Stage Iuterine 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 druguntil the end of the study

  • Treatment with other non-live vaccines within 14 days prior to the first dose ofstudy drug until the end of the study

Study Design

Total Participants: 162
Treatment Group(s): 2
Primary Treatment: Selnoflast
Phase: 2
Study Start date:
June 15, 2026
Estimated Completion Date:
February 28, 2028

Connect with a study center

  • Cardiovascular Research Foundation of Southern California

    Beverly Hills, California 90210
    United States

    Active - Recruiting

  • Amnova Clinical Research

    Irvine, California 92604
    United States

    Active - Recruiting

  • Alliance Clinical West Hills (Focus Clinical Research)

    West Hills, California 91307
    United States

    Active - Recruiting

  • Asha Clinical Research-Munster,Llc

    Hammond, Indiana 46324
    United States

    Active - Recruiting

  • Preferred Primary Care Physicians, Inc

    Pittsburgh, Pennsylvania 15243
    United States

    Active - Recruiting

  • Eastside Research Associates, LLC dba Era Health Research

    Redmond, Washington 98036
    United States

    Active - Recruiting

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