Selnoflast for Atherosclerosis

(RIVULET Trial)

Recruiting at 4 trial locations

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

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Genentech, Inc.

Must be taking: Standard-of-care therapy

Must not be taking: Live vaccines, Non-live vaccines

Disqualifiers: Heart failure, Hypertension, Immunocompromised, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

162 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Clinical Trials

Principal Investigator

Genentech, Inc.

Are You a Good Fit for This Trial?

Inclusion Criteria

* 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

* 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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive selnoflast or placebo orally twice a day for 12 weeks

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Selnoflast

How Is the Trial Designed?

Group I: Selnoflast Experimental Treatment 1 Intervention

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

Group II: Placebo Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Genentech, Inc.

Lead Sponsor

Trials

1,578

Recruited

569,000+

Ashley Magargee

Genentech, Inc.

Chief Executive Officer since 2024

MBA from Harvard University, BA from Princeton University

Levi Garraway

Genentech, Inc.

Chief Medical Officer since 2021

MD, PhD