162 Participants NeededMy employer runs this trial

Selnoflast for Atherosclerosis

(RIVULET Trial)

Recruiting at 23 trial locations
RS
Fr
Overseen ByFastest response: use the inquiry form. No email attachments https://www.gene.com/contact-us/submit-medical-inquiry
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Genentech, Inc.
Must be taking: Standard-of-care therapy
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called selnoflast for individuals with atherosclerosis, a condition where fat clogs the arteries, leading to heart problems. Researchers aim to determine if selnoflast can reduce the risk of major heart events when added to standard treatments. Participants will take either selnoflast or a placebo (a sugar pill) twice daily for 12 weeks. Those diagnosed with atherosclerosis and currently managing it with medication might be suitable for this trial. As a Phase 2 trial, this research measures how well selnoflast works in an initial, smaller group, offering participants a chance to contribute to important advancements in heart health.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop your current medications, but it mentions that participants should be on stable treatment for atherosclerosis with standard-of-care medications. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that selnoflast is likely to be safe for humans?

Research has shown that selnoflast is generally safe for people. In earlier studies, it demonstrated a good safety record. For example, one study identified seventeen manageable side effects among participants. Most importantly, participants tolerated the drug well.

Another study found that selnoflast behaved predictably at different doses, indicating good safety.

Additionally, selnoflast has been tested for other conditions, such as ulcerative colitis, providing some existing safety information, though details may vary by condition. Overall, research so far suggests that selnoflast is well-tolerated with few side effects.12345

Why do researchers think this study treatment might be promising for atherosclerosis?

Unlike the standard cholesterol-lowering medications like statins, Selnoflast offers a new approach to treating atherosclerosis by targeting inflammation in the arterial walls. This novel mechanism of action sets it apart from current treatments, which primarily focus on reducing lipid levels in the blood. Researchers are particularly excited about Selnoflast's potential to address the root cause of plaque formation, possibly leading to more effective management of atherosclerosis. Additionally, its oral administration twice a day makes it a convenient option for patients.

What evidence suggests that selnoflast might be an effective treatment for atherosclerosis?

Research has shown that selnoflast might help treat atherosclerosis, a condition affecting the arteries. Studies have found that selnoflast can lower inflammation markers linked to heart disease, such as IL-6 and hsCRP. One study discovered that selnoflast reduced IL-18 levels by 30%, potentially decreasing artery inflammation. The drug targets inflammation, a major factor in atherosclerosis. These findings suggest that selnoflast could be promising for people with this condition. Participants in this trial will receive either selnoflast or a placebo to further evaluate its effectiveness.13467

Who Is on the Research Team?

CT

Clinical Trials

Principal Investigator

Genentech, Inc.

Are You a Good Fit for This Trial?

This trial is for adults with confirmed atherosclerosis who are at high risk for serious heart problems. Participants must already be on stable treatment for their condition and meet specific heart rhythm and imaging criteria.

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
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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

Trial Overview

The study compares the new drug Selnoflast to a placebo, both given alongside standard treatments, to see if Selnoflast can reduce blood vessel inflammation in people with atherosclerosis. Participants are randomly assigned to either group.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: SelnoflastExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Genentech, Inc.

Lead Sponsor

Trials
1,578
Recruited
569,000+
Ashley Magargee profile image

Ashley Magargee

Genentech, Inc.

Chief Executive Officer since 2024

MBA from Harvard University, BA from Princeton University

Levi Garraway profile image

Levi Garraway

Genentech, Inc.

Chief Medical Officer since 2021

MD, PhD

Citations

NCT07448038 | A Study to Evaluate the Efficacy, Safety, ...

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 ...

ISRCTN10520571: A study to assess the safety, ...

The purpose of this study and sub-study is to compare the effects, good or bad, of selnoflast versus medication that looks like a drug but has no active ...

A Study to Evaluate the Efficacy, Safety, Pharmacodynamics ...

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 ...

Selnoflast for Atherosclerosis (RIVULET 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 ...

A randomized, double‐blind phase 1b study evaluating ... - PMC

In our study, we used single‐cell RNA sequencing as an investigational tool for evaluating the effects of selnoflast on changes in cell ...

Abstract 4366197: Selnoflast reduces markers of systemic ...

Selnoflast demonstrated a favorable safety profile, consistent with prior studies. Seventeen adverse events (AEs) were reported: 11 AEs in 3 ...

Clinical Trial – Coronary Artery Disease – Safety, Pharma...

Access the clinical trial evaluating safety, pharmacokinetics, and pharmacodynamics of selnoflast in patients with coronary artery disease.