AtherosclerosisPhase 2RIVULETNCT07448038
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
A Phase 2 study testing Selnoflast in people with Atherosclerosis, run by Genentech, Inc. at 25 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atherosclerosis
- What is being tested?
- Selnoflast
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 162 participants
- Where
- 25 sitesin 2 countries
- Study dates
- 5 Jun 2026to 28 Feb 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
25 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Reference Study ID Number: GC46102 https://forpatients.roche.com/ contact
Fastest response: use the inquiry form. No email attachments https://www.gene.com/contact-us/submit-medical-inquiry contact
25 sites in 2 countries
United States24 sites, 24 recruiting
- Recruiting
Cardiovascular Research Foundation of Southern California
Beverly Hills, California, 90210
- Recruiting
National Heart Institute
Beverly Hills, California, 90211
- Recruiting
Profound Research LLC at Cardiology and Vascular Associates - CAVA
Bloomfield Hills, Michigan, 48304
- Recruiting
UNC Heart & Vascular
Chapel Hill, North Carolina, 27514
- Recruiting
Southwest Family Medicine Associates
Dallas, Texas, 75235
- Recruiting
Profound Research LLC at Millenium Cardiology
Farmington Hills, Michigan, 48334
- Recruiting
Ahmed Arif Medical Research Center (AA MRC LLC )
Flint, Michigan, 48504
- Recruiting
Asha Clinical Research-Munster,Llc
Hammond, Indiana, 46324
- Recruiting
East Texas Cardiology PA
Houston, Texas, 77002
- Recruiting
Cardiovascular Specialists of Willowbrook
Houston, Texas, 77070
- Recruiting
Amnova Clinical Research
Irvine, California, 92604
- Recruiting
UCLA Health System - UCLA Cardiovascular Center
Los Angeles, California, 90095
- Recruiting
Inpatient Research Clinic (Las Palmas Medical Research Center)
Miami Lakes, Florida, 33014
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55455
- Recruiting
Vanderbilt University School of Medicine (VUSM) - Vanderbilt Translational and Clinical Cardiovascular Research Center (VTRACC)
Nashville, Tennessee, 37203
- Recruiting
Yale University School of Medicine Yale-New Haven Hospital (YNHH) - Smilow Cancer Hospital
New Haven, Connecticut, 06520-8040
- Recruiting
DiGiovanna Inst for Med Ed&Res
North Massapequa, New York, 11758-1802
- Recruiting
University of Nebraska Medical Center
Omaha, Nebraska, 69198-4130
- Recruiting
Preferred Primary Care Physicians, Inc
Pittsburgh, Pennsylvania, 15243
- Recruiting
Eastside Research Associates, LLC dba Era Health Research
Redmond, Washington, 98036
- Recruiting
UT Health San Antonio
San Antonio, Texas, 78229
- Recruiting
NorthBay Clinical Research
Santa Rosa, California, 95405
- Recruiting
Washington University, School of Medicine
St Louis, Missouri, 63110
- Recruiting
Alliance Clinical West Hills (Focus Clinical Research)
West Hills, California, 91307
Canada1 site, 1 recruiting
- Recruiting
Cardio Health Clinical Trials
Hamilton, Ontario, L8W 3K5
About this study
Official 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
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.
- Conditions
- Atherosclerosis
- Being tested
- Selnoflast, Placebo
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SelnoflastDrug
Also called RO7486967
Selnoflast will be administered as per the schedule specified in the respective arm.
PlaceboDrug
Placebo will be administered as per the schedule specified in the respective arm.
| Study group | Role | What they receive |
|---|---|---|
| Selnoflast | Experimental | Participants will receive selnoflast, orally (PO), twice a day (BID) for 12 weeks. Receives: Drug: Selnoflast |
| Placebo | Placebo comparator | Participants will receive placebo, PO, BID for 12 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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])
hsCRP=high-sensitivity C-reactive protein.
Measured: Baseline up to Week 12
Secondary outcomes (7)
Change From Baseline in mdsTBR of Index Vessel at Week 12 in all Participants (hsCRP < 2 mg/L and ≥ 2mg/L)
Measured: 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)
Measured: Baseline and Week 12
Change From Baseline in mdsTBR of Carotids at Week 12 in Participants With Baseline Elevated hsCRP (≥ 2 mg/L)
Measured: 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)
Measured: 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)
Measured: Baseline and Week 12
Number of Participants With Adverse Events (AEs) and Severity of AEs Determined According to the NCI CTCAE v5.0 Grading Scale
NCI CTCAE v5.0 = National Cancer Institute's Common Terminology Criteria for Adverse Events, Version 5.0.
Measured: Up to approximately 22 weeks
Plasma Concentration of Selnoflast at Specified Timepoints
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study start5 Jun 2026
- Primary completion31 Jan 2028 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07448038
- Sponsor's protocol ID
- GC46102
- Acronym
- RIVULET
- Status last verified
- Sep 2026
- First submitted
- 25 Feb 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07448038
- Acronym / sponsor ID
- RIVULET / GC46102
- Conditions
- Atherosclerosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 162 participants (estimated)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Jun 2026 (actual)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 28 Feb 2028 (estimated)
- First posted
- 4 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Selnoflast | Experimental | Drug: SelnoflastParticipants will receive selnoflast, orally (PO), twice a day (BID) for 12 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive placebo, PO, BID for 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SelnoflastAlso: RO7486967Selnoflast will be administered as per the schedule specified in the respective arm. | Drug | Selnoflast |
| PlaceboPlacebo will be administered as per the schedule specified in the respective arm. | Drug | Placebo |
Primary outcome
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.
7 secondary outcomes
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
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
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
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
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
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
Plasma Concentration of Selnoflast at Specified Timepoints
Time frame: Up to 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Reference Study ID Number: GC46102 https://forpatients.roche.com/ contact
Fastest response: use the inquiry form. No email attachments https://www.gene.com/contact-us/submit-medical-inquiry contact
Clinical Trials study director
Genentech, Inc.
25 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Selnoflast in people with Atherosclerosis, run by Genentech, Inc. at 25 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Reference Study ID Number: GC46102 https://forpatients.roche.com/ (888-662-6728, global-roche-genentech-trials@gene.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.