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NCT07303777PHASE2Recruiting

Efficacy, Safety, and PopPK Profile of ABP-745 in Patients With Atherosclerosis

Atom Therapeutics Co., Ltd

Start Date

4/23/2026

Completion Date

4/1/2028

Summary

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.

Eligibility Criteria

Age Range: 18 years to 75 years

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.

Interventions

DRUG

ABP-745 Dose A

DRUG

Placebo

DRUG

ABP-745 Dose B

DRUG

ABP-745 Dose C

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Conditions

Atherosclerosis Cardiovascular DiseaseASCVDASCVD Management

Locations

Cardiovascular Research Foundation of Southern California

Beverly Hills, California 90210

United States

Cardiovascular Institute of San Diego INC

San Diego, California 91911

United States

The Lundquist Institute

Torrance, California 90502

United States

Washington University School of Medicine, St.louis

St Louis, Missouri 63130

United States

NovaTrails

Newcastle, New South Wales 2290

Australia

University of the Sunshine Coast Clinical Trials Unit - Morayfield

Morayfield, Queensland 4506

Australia

Core Research Group Pty Ltd

Brisbane,

Australia

UniSC Clinical Trials (Brisbane)

Brisbane,

Australia

Cognivus

Wahroonga,

Australia

Beijing Friendship Hospital, Capital Medical University

Beijing,

China

Peking Union Medical College Hospital

Beijing,

China

Peking University First Hospital

Beijing,

China

Xuanwu Hospital Capital Medical University

Beijing,

China

Dalian Second Hospital

Dalian,

China

Guangdong Province Hospital

Guangzhou,

China

Sir Run Run Shaw Hospital of Zhejiang University School of Medicine

Hangzhou,

China

The First Affiliated Hospital of Zhejiang University school of medicine

Hangzhou,

China

Zhejiang Provincial People's Hospital

Hangzhou,

China

Jinan Central Hospital

Jinan,

China

Jiangsu Province Hospital

Nanjing,

China

Nanjing Drum Tower Hospital

Nanjing,

China

Huashan Hospital Fudan University

Shanghai,

China

Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai,

China

Shanghai General Hospital

Shanghai,

China

The Zhongshan Hospital Affiliated to Fudan University

Shanghai,

China

The First Affiliated Hospital of Soochow University

Suzhou,

China

Tianjin General Hospital

Tianjin,

China

Renmin Hospital of Wuhan University

Wuhan,

China

Wuxi People's Hospital

Wuxi,

China

Shaanxi Provincial People's Hospital

Xi'an,

China

The First Affiliated Hospital of Xian Jiaotong University

Xi'an,

China

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an,

China

The Affiliated Hospital of Xuzhou Medical College

Xuzhou,

China