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Efficacy, Safety, and PopPK Profile of ABP-745 in Patients With Atherosclerosis
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Study to Evaluate the Efficacy, Safety, and Population Pharmacokinetics (PopPK) Profile of ABP-745 in Patients With Atherosclerosis
Who can join
Ages 18 to 75 · All sexes
Full eligibility criteria
Inclusion Criteria: Unless otherwise specified, subjects must meet all of the following criteria at screening: * Diagnosed with coronary at herosclerosis, and coronary angiography. * Male or female at 18-75 years of age (inclusive). * Weight ≥40 kg. * Currently using any oral lipid-lowering therapy. * Able to understand and willing to sign an ICF and comply with study requirements. * A woman or man of childbearing potential agreeing to use medically approved contraceptive methods from the screening until 3 months after the last study dose. Exclusion Criteria: Unless otherwise specified, subjects are excluded from the study if any of the following criteria is met: * History of stroke within the past 6 months. * Uncontrolled arrhythmia within 3 months prior to screening. * Evidence of any active or suspected cancer within 3 years prior to the screening. * Having undergone any major surgery within 3 months prior to the screening or planning to undergo any major surgery during the study. * Presence or suspicion of ongoing of any serious infection. * Human immunodeficiency virus (HIV) infection.
About the study
This is a multicenter, randomized, double-blind, placebo parallel controlled study to evaluate the preliminary efficacy, safety, and PopPK profile of ABP-745 in patients with ASCVD. Efficacy of ABP-745 in reducing atherosclerotic plaque compared with placebo will be evaluated in participants with ASCVD. The primary efficacy measurement will be assessed at 52W of treatment.
What is being tested
- ABP-745 Dose A (drug)
- Placebo (drug)
- ABP-745 Dose B (drug)
- ABP-745 Dose C (drug)
Sponsor: Atom Therapeutics Co., Ltd · Participants: 200 · Started: Apr 23, 2026
Contact the study team
- Qiang Shi · Phone: 86+ 19117302212
Official record on ClinicalTrials.gov — NCT07303777
Locations in the U.S.
| California | Cardiovascular Research Foundation of Southern California, Beverly Hills (Not yet recruiting) Cardiovascular Institute of San Diego INC, San Diego (Not yet recruiting) The Lundquist Institute, Torrance (Not yet recruiting) |
| Missouri | Washington University School of Medicine, St.louis, St Louis (Not yet recruiting) |
From ClinicalTrials.gov, data retrieved Oct 1, 2026. Each study sets its own eligibility; the study team decides who can join.