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NCT Number: 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

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.

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Key information

Conditions

Atherosclerosis Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cardio Health Clinical Trials, Hamilton, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Selnoflast

Drug

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

Other names: RO7486967

Placebo

Drug

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

Primary outcomes

  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])

    Time frame: Baseline up to Week 12

    hsCRP=high-sensitivity C-reactive protein.

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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.

  7. Plasma Concentration of Selnoflast at Specified Timepoints

    Time frame: Up to 12 weeks

Interested in participating?

Recruiting

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study title

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

Acronym: RIVULET

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 4, 2026
Registry last updated
Sep 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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