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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Atherosclerosis Cardiovascular Disease, ASCVD, ASCVD Management

In brief

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.

Key facts

Study ID

NCT07303777

Run by

Atom Therapeutics Co., Ltd

People needed

200

Starts

2026-04-23

Expected to finish

2028-04-01

Last updated by the study team

2026-04-28

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• The Zhongshan Hospital Affiliated to Fudan University — Shanghai, China (enrolling)
• Cardiovascular Institute of San Diego INC — San Diego, California, United States
• The Lundquist Institute — Torrance, California, United States
• Washington University School of Medicine, St.louis — St Louis, Missouri, United States
• NovaTrails — Newcastle, New South Wales, Australia
• University of the Sunshine Coast Clinical Trials Unit - Morayfield — Morayfield, Queensland, 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 First Affiliated Hospital of Soochow University — Suzhou, China

Full record on ClinicalTrials.gov

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