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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorGenentech, Inc.

About this trial

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

Qualifiers

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

Disqualifiers

Individuals with Class III and IV heart failure

Uncontrolled cardiac arrhythmia

Uncontrolled hypertension

Suspected or known immunocompromised state

Trial design

Treatments tested in this trial

  • Selnoflast
  • Placebo

Treatment groups

162 Participants
are divided into 2 treatment groups

Locations

15
California
Cardiovascular Research Foundation of Southern California90210, Beverly Hills United States
National Heart Institute90211, Beverly Hills United States
Amnova Clinical Research92604, Irvine United States
Alliance Clinical West Hills (Focus Clinical Research)91307, West Hills United States

Sponsors and collaborators

Genentech, Inc.

Lead sponsor