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

Part of paid clinical trials in Beverly Hills, California.

Sponsor
Genentech, Inc.
Study ID
NCT07448038
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Atherosclerosis

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jun 15, 2026
Status verified
Jun 2026
Primary completion
Jan 31, 2028
Completion
Feb 28, 2028

Study Design

Enrollment
162 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Selnoflast
    Participants will receive selnoflast, orally (PO), twice a day (BID) for 12 weeks.
  • Placebo Comparator: Placebo
    Participants will receive placebo, PO, BID for 12 weeks.

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 ]

Central Contacts

  • Reference Study ID Number: GC46102 https://forpatients.roche.com/
    888-662-6728
    [email protected]
  • Fastest response: use the inquiry form. No email attachments https://www.gene.com/contact-us/submit-medical-inquiry

Locations (11)

FacilityCityStateZIPSite coordinators
Cardiovascular Research Foundation of Southern CaliforniaBeverly HillsCalifornia90210-
Amnova Clinical ResearchIrvineCalifornia92604-
Alliance Clinical West Hills (Focus Clinical Research)West HillsCalifornia91307-
Inpatient Research Clinic (Las Palmas Medical Research Center)Miami LakesFlorida33014-
Asha Clinical Research-Munster,LlcHammondIndiana46324-
Profound Research LLC at Cardiology and Vascular Associates - CAVABloomfield HillsMichigan48304-
Ahmed Arif Medical Research Center (AA MRC LLC )FlintMichigan48504-
DiGiovanna Inst for Med Ed&ResNorth MassapequaNew York11758-1802-
Preferred Primary Care Physicians, IncPittsburghPennsylvania15243-
East Texas Cardiology PAHoustonTexas77002-
Eastside Research Associates, LLC dba Era Health ResearchRedmondWashington98036-

Find similar trials in Beverly Hills, CA

By research site
Cardiovascular Research Foundation of Southern California· Beverly Hills, CAAmnova Clinical Research· Irvine, CAAlliance Clinical West Hills (Focus Clinical Research)· West Hills, CAInpatient Research Clinic (Las Palmas Medical Research Center)· Miami Lakes, FLAsha Clinical Research-Munster,Llc· Hammond, INProfound Research LLC at Cardiology and Vascular Associates - CAVA· Bloomfield Hills, MI

Related Studies