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

NCT07448038 | Recruiting Phase 2 FDA Drug

• 1 other identifier: GC46102
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Atherosclerosis

Outcome Measures

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.

  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)

  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)

  Baseline and Week 12

• Change From Baseline in mdsTBR of Carotids at Week 12 in Participants With Baseline Elevated hsCRP (≥ 2 mg/L)

  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)

  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)

  Baseline and Week 12

Study Arms (2)

Selnoflast

EXPERIMENTAL

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

Drug: Selnoflast

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Selnoflast DRUG

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

Also known as: RO7486967

Selnoflast

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (6)

Cardiovascular Research Foundation of Southern California

Beverly Hills, California, 90210, United States

RECRUITING

Amnova Clinical Research

Irvine, California, 92604, United States

RECRUITING

Alliance Clinical West Hills (Focus Clinical Research)

West Hills, California, 91307, United States

RECRUITING

Asha Clinical Research-Munster,Llc

Hammond, Indiana, 46324, United States

RECRUITING

Preferred Primary Care Physicians, Inc

Pittsburgh, Pennsylvania, 15243, United States

RECRUITING

Eastside Research Associates, LLC dba Era Health Research

Redmond, Washington, 98036, United States

RECRUITING

MeSH Terms

Conditions

Atherosclerosis

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Clinical Trials

  Genentech, Inc.

  STUDY DIRECTOR

Central Study Contacts

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

CONTACT

888-662-6728; global-roche-genentech-trials@gene.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2026
• First Posted: March 4, 2026
• Study Start (Estimated): June 15, 2026
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): February 28, 2028
• Last Updated: May 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

US (6)