NCT07448038 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
| NCT ID | NCT07448038 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Genentech, Inc. |
| Condition | Atherosclerosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 162 participants |
| Start Date | 2026-06-15 |
| Primary Completion | 2028-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 162 participants in total. It began in 2026-06-15 with a primary completion date of 2028-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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 * 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 Exclusion Criteria: * 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
Contact & Investigator
Reference Study ID Number: GC46102 https://forpatients.roche.com/
✉ global-roche-genentech-trials@gene.com📞 888-662-6728
Clinical Trials
STUDY DIRECTOR
Genentech, Inc.
Frequently Asked Questions
Who can join the NCT07448038 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Atherosclerosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07448038 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07448038 currently recruiting?
Yes, NCT07448038 is actively recruiting participants. Contact the research team at global-roche-genentech-trials@gene.com for enrollment information.
Where is the NCT07448038 trial being conducted?
This trial is being conducted at Beverly Hills, United States, Irvine, United States, West Hills, United States, Hammond, United States and 2 additional locations.
Who is sponsoring the NCT07448038 clinical trial?
NCT07448038 is sponsored by Genentech, Inc.. The principal investigator is Clinical Trials at Genentech, Inc.. The trial plans to enroll 162 participants.