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 (RIVULET)

September 1, 2026 updated by: Genentech, Inc.

A Phase IIa, Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Efficacy, Safety, Pharmacodynamics, and Pharmacokinetics of Selnoflast in Reducing Vascular Inflammation in Patients With Atherosclerosis at Risk for Major Adverse Cardiac Events

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

162

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Fastest response: use the inquiry form. No email attachments https://www.gene.com/contact-us/submit-medical-inquiry

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8W 3K5
        • Recruiting
        • Cardio Health Clinical Trials
  • United States
    • California
      • Beverly Hills, California, United States, 90210
        • Recruiting
        • Cardiovascular Research Foundation of Southern California
      • Beverly Hills, California, United States, 90211
        • Recruiting
        • National Heart Institute
      • Irvine, California, United States, 92604
        • Recruiting
        • Amnova Clinical Research
      • Santa Rosa, California, United States, 95405
        • Recruiting
        • NorthBay Clinical Research
      • West Hills, California, United States, 91307
        • Recruiting
        • Alliance Clinical West Hills (Focus Clinical Research)
    • Connecticut
      • New Haven, Connecticut, United States, 06520-8040
        • Recruiting
        • Yale University School of Medicine Yale-New Haven Hospital (YNHH) - Smilow Cancer Hospital
    • Florida
      • Miami Lakes, Florida, United States, 33014
        • Recruiting
        • Inpatient Research Clinic (Las Palmas Medical Research Center)
    • Indiana
      • Hammond, Indiana, United States, 46324
        • Recruiting
        • Asha Clinical Research-Munster,Llc
    • Michigan
      • Bloomfield Hills, Michigan, United States, 48304
        • Recruiting
        • Profound Research LLC at Cardiology and Vascular Associates - CAVA
      • Farmington Hills, Michigan, United States, 48334
        • Recruiting
        • Profound Research LLC at Millenium Cardiology
      • Flint, Michigan, United States, 48504
        • Recruiting
        • Ahmed Arif Medical Research Center (AA MRC LLC )
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • University of Minnesota
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University, School of Medicine
    • Nebraska
      • Omaha, Nebraska, United States, 69198-4130
        • Recruiting
        • University of Nebraska Medical Center
    • New York
      • North Massapequa, New York, United States, 11758-1802
        • Recruiting
        • DiGiovanna Inst for Med Ed&Res
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-7075
        • Recruiting
        • UNC Heart & Vascular
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15243
        • Recruiting
        • Preferred Primary Care Physicians, Inc
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Vanderbilt University School of Medicine (VUSM) - Vanderbilt Translational and Clinical Cardiovascular Research Center (VTRACC)
    • Texas
      • Dallas, Texas, United States, 75235
        • Recruiting
        • Southwest Family Medicine Associates
      • Houston, Texas, United States, 77002
        • Recruiting
        • East Texas Cardiology PA
      • Houston, Texas, United States, 77070
        • Recruiting
        • Cardiovascular Specialists of Willowbrook
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • UT Health San Antonio
    • Washington
      • Redmond, Washington, United States, 98036
        • Recruiting
        • Eastside Research Associates, LLC dba Era Health Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Selnoflast
Participants will receive selnoflast, orally (PO), twice a day (BID) for 12 weeks.
Drug: Selnoflast
Selnoflast will be administered as per the schedule specified in the respective arm.
Other Names:
  • RO7486967
Placebo Comparator: Placebo
Participants will receive placebo, PO, BID for 12 weeks.
Drug: Placebo
Placebo will be administered as per the schedule specified in the respective arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
hsCRP=high-sensitivity C-reactive protein.
Baseline up to Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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
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
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
Baseline and Week 12
Plasma Concentration of Selnoflast at Specified Timepoints
Time Frame: Up to 12 weeks
Up to 12 weeks
Number of Participants With Adverse Events (AEs) and Severity of AEs Determined According to the NCI CTCAE v5.0 Grading Scale
Time Frame: Up to approximately 22 weeks
NCI CTCAE v5.0 = National Cancer Institute's Common Terminology Criteria for Adverse Events, Version 5.0.
Up to approximately 22 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genentech, Inc.

Investigators

  • Study Director: Clinical Trials, Genentech, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 5, 2026

Primary Completion (Estimated)

January 31, 2028

Study Completion (Estimated)

February 28, 2028

Study Registration Dates

First Submitted

February 25, 2026

First Submitted That Met QC Criteria

February 25, 2026

First Posted (Actual)

March 4, 2026

Study Record Updates

Last Update Posted (Actual)

September 3, 2026

Last Update Submitted That Met QC Criteria

September 1, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GC46102

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe