ClinicalTrials.gg
RecruitingNCT07448038RIVULETUpdated Nov 3, 2026

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 interventional study of Selnoflast and Placebo in Atherosclerosis, sponsored by Genentech, Inc.. Recruiting at 25 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.

Sponsored by Genentech, Inc. (part of Hoffmann-La Roche) · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Jun 2026; still recruiting 5 months later.
Updated Nov 3, 20262 sites added1 site removedGo to Updates ↓

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Phase
Phase 2
Study type
Interventional
Enrollment
162
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 468 studies in Atherosclerosis with a site in United States — 47 open to participants now, 75 under way, 17 of them phase 3. Atherosclerosis · United States.

Planned enrollment
141st of 328
162 · median 119
Started
2026
with 13 others
Phase 2
63 of 468
7 open now
Primary completion
2028-01
later than 40 of 70 live
Registered
458th of 468
by date

Among the 468 studies in Atherosclerosis with a site in United States, this one is the 141st largest by planned enrollment of the 328 interventional ones that give a count, is one of 14 that started in 2026, is one of 63 in phase 2, reaches primary completion later than 40 of the 70 other live ones, and was the 458th registered.

Atherosclerosis

1,518 studies on the registry are indexed under Atherosclerosis; 225 are open to participants now.

Browse Atherosclerosis studies →

Open to participants now

47 of the 468 studies in Atherosclerosis with a site in United States are open now. Recruiting first, the newest first:

41 more — sign in →

All 47 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 161 Atherosclerosis studies recruiting now, 84 (52%) set no upper age limit and 33 (20%) stop at 75 or younger; 16 take children under 18; 33 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 468 studies in Atherosclerosis with a site in United States, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Atherosclerosis

Browse trials for

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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
  • corrected through use of Fridericia's formula (QTcF) of ≤ 450 milliseconds (ms) in men and ≤ 470 ms in women by a single 12-lead (ECG) recording

Exclusion criteria

Exclusion Criteria:

  • Individuals with Class III and IV heart failure
  • Uncontrolled cardiac arrhythmia
  • Uncontrolled hypertension
  • Suspected or known state
  • Planned procedure or surgery during the study and any major surgery within 90 days prior to screening Visit 1
  • History of 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 (HBV) infection at screening
  • Positive virus (HCV) antibody test at screening
  • Positive (HIV) test at screening
  • Estimated \<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 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
Terms in these criteria, in plain language(9)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
162 participants (estimated)

Study arms

  • Experimental
    Selnoflast

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

    Drug: Selnoflast

  • Placebo comparator
    Placebo

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

    Drug: Placebo

Interventions

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

    Also known as: RO7486967

  • DrugPlacebo

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

06

What researchers measure

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])

    hsCRP=high-sensitivity C-reactive protein.

    Time frame: Baseline up to Week 12

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

    NCI CTCAE v5.0 = National Cancer Institute's Common Terminology Criteria for Adverse Events, Version 5.0.

    Time frame: Up to approximately 22 weeks

  7. Plasma Concentration of Selnoflast at Specified Timepoints

    Time frame: Up to 12 weeks

07

Study locations

25 of 25 sites recruiting
  • Cardiovascular Research Foundation of Southern California
    Beverly Hills, California 90210, United States
    Recruiting
  • National Heart Institute
    Beverly Hills, California 90211, United States
    Recruiting
  • Amnova Clinical Research
    Irvine, California 92604, United States
    Recruiting
  • UCLA Health System - UCLA Cardiovascular Center
    Los Angeles, California 90095, United States
    Recruiting
  • NorthBay Clinical Research
    Santa Rosa, California 95405, United States
    Recruiting
  • Alliance Clinical West Hills (Focus Clinical Research)
    West Hills, California 91307, United States
    Recruiting
  • Yale University School of Medicine Yale-New Haven Hospital (YNHH) - Smilow Cancer Hospital
    New Haven, Connecticut 06520-8040, United States
    Recruiting
  • Inpatient Research Clinic (Las Palmas Medical Research Center)
    Miami Lakes, Florida 33014, United States
    Recruiting
  • Asha Clinical Research-Munster,Llc
    Hammond, Indiana 46324, United States
    Recruiting
  • Profound Research LLC at Cardiology and Vascular Associates - CAVA
    Bloomfield Hills, Michigan 48304, United States
    Recruiting
  • Profound Research LLC at Millenium Cardiology
    Farmington Hills, Michigan 48334, United States
    Recruiting
  • Ahmed Arif Medical Research Center (AA MRC LLC )
    Flint, Michigan 48504, United States
    Recruiting
  • University of Minnesota
    Minneapolis, Minnesota 55455, United States
    Recruiting
  • Washington University, School of Medicine
    St Louis, Missouri 63110, United States
    Recruiting
  • University of Nebraska Medical Center
    Omaha, Nebraska 69198-4130, United States
    Recruiting
  • DiGiovanna Inst for Med Ed&Res
    North Massapequa, New York 11758-1802, United States
    Recruiting
  • UNC Heart & Vascular
    Chapel Hill, North Carolina 27599, United States
    Recruiting
  • Preferred Primary Care Physicians, Inc
    Pittsburgh, Pennsylvania 15243, United States
    Recruiting
  • Vanderbilt University School of Medicine (VUSM) - Vanderbilt Translational and Clinical Cardiovascular Research Center (VTRACC)
    Nashville, Tennessee 37203, United States
    Recruiting
  • Southwest Family Medicine Associates
    Dallas, Texas 75235, United States
    Recruiting
  • East Texas Cardiology PA
    Houston, Texas 77002, United States
    Recruiting
  • Cardiovascular Specialists of Willowbrook
    Houston, Texas 77070, United States
    Recruiting
  • UT Health San Antonio
    San Antonio, Texas 78229, United States
    Recruiting
  • Eastside Research Associates, LLC dba Era Health Research
    Lynnwood, Washington 98036, United States
    Recruiting
  • Cardio Health Clinical Trials
    Hamilton, Ontario L8W 3K5, Canada
    Recruiting
08

References and documents

Individual participant data

Plan to share: 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

09

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2026 (actual). Primary completion is estimated for Jan 2028, 19 months after the start.

Of 46 phase 2 interventional studies under Atherosclerosis, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 59. This study's planned 19 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 25, 2026
First posted
Mar 4, 2026
StartActual
Jun 5, 2026
Primary completionEst.
Jan 31, 2028
CompletionEst.
Feb 28, 2028
Last update
Nov 3, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
2 sites added, 1 site removed
Show 2 added (2 United States)
  • UCLA Health System - UCLA Cardiovascular Center · Los Angeles, United States
  • Eastside Research Associates, LLC dba Era Health Research · Lynnwood, United States
Show 1 removed
  • Eastside Research Associates, LLC dba Era Health Research · Redmond, United States
across 2 updates, Sep 29, 2026 – Nov 3, 2026
Show all 2 updates
  1. Nov 3, 2026
    1 site added, 1 site removed
    Show site
    • Eastside Research Associates, LLC dba Era Health Research · Lynnwood, United States
    Show 1 removed
    • Eastside Research Associates, LLC dba Era Health Research · Redmond, United States
    + 1 other change: verification date
  2. Sep 29, 2026
    1 site added
    Show site
    • UCLA Health System - UCLA Cardiovascular Center · Los Angeles, United States

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07448038
Lead sponsor
Genentech, Inc.
Responsible party
Sponsor
First posted
Mar 4, 2026
Start date
Jun 5, 2026
Primary completion
Jan 31, 2028 (estimated)
Completion
Feb 28, 2028 (estimated)
Last update
Nov 3, 2026

Study contacts

Reference Study ID Number: GC46102 https://forpatients.roche.com/
Contact
global-roche-genentech-trials@gene.com
888-662-6728
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.

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Discussion

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Studies of the drug tested here: Selnoflast

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