ABP-745 to reduce atherosclerotic plaque in people with ASCVD

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

This trial will test whether ABP-745 reduces atherosclerotic plaque over 52 weeks in adults (18–75) with ASCVD who are already taking oral lipid-lowering therapy.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Atom Therapeutics Co., Ltd (Industry-sponsored)
• Locations: 33 sites (Beverly Hills, California and 32 other locations)
• Trial ID: NCT07303777 on ClinicalTrials.gov

What this trial studies

This is a multicenter, randomized, double-blind, placebo-controlled Phase 2 trial comparing three dose levels of ABP-745 against placebo in adults with atherosclerotic cardiovascular disease. Participants will remain on their routine oral lipid-lowering therapy and be randomized to one of four arms (three ABP-745 doses or placebo). The study will collect safety data, population pharmacokinetics (PopPK), and imaging-based measures of atherosclerotic plaque, with the primary efficacy measurement at 52 weeks of treatment. Clinical visits and assessments will track adverse events and plaque changes over the treatment period.

Who should consider this trial

Good fit: Adults aged 18–75 with documented coronary atherosclerosis who weigh at least 40 kg, are on oral lipid-lowering therapy, and can comply with study procedures (including agreed contraception if applicable) are the intended candidates.

Not a fit: People with a recent stroke (within 6 months), uncontrolled arrhythmia, recent major surgery, active or recent cancer, those outside the specified age/weight ranges, or not on oral lipid-lowering therapy are unlikely to be eligible or to receive benefit.

Why it matters

Potential benefit: If successful, ABP-745 could reduce plaque burden and potentially lower future cardiovascular risk beyond standard lipid-lowering therapy.

How similar studies have performed: Some other lipid- and plaque-targeting therapies (for example PCSK9 inhibitors) have reduced plaque or cardiovascular events, but ABP-745 appears to be a novel agent with limited prior human efficacy data.

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.

Where this trial is running

Beverly Hills, California and 32 other locations

• Cardiovascular Research Foundation of Southern California — Beverly Hills, California, United States (Not_yet_recruiting)
• Cardiovascular Institute of San Diego INC — San Diego, California, United States (Not_yet_recruiting)
• The Lundquist Institute — Torrance, California, United States (Not_yet_recruiting)
• Washington University School of Medicine, St.louis — St Louis, Missouri, United States (Not_yet_recruiting)
• NovaTrails — Newcastle, New South Wales, Australia (Not_yet_recruiting)
• University of the Sunshine Coast Clinical Trials Unit - Morayfield — Morayfield, Queensland, Australia (Not_yet_recruiting)
• Core Research Group Pty Ltd — Brisbane, Australia (Not_yet_recruiting)
• UniSC Clinical Trials (Brisbane) — Brisbane, Australia (Not_yet_recruiting)
• Cognivus — Wahroonga, Australia (Not_yet_recruiting)
• Beijing Friendship Hospital, Capital Medical University — Beijing, China (Not_yet_recruiting)
• Peking Union Medical College Hospital — Beijing, China (Not_yet_recruiting)
• Peking University First Hospital — Beijing, China (Not_yet_recruiting)
• Xuanwu Hospital Capital Medical University — Beijing, China (Not_yet_recruiting)
• Dalian Second Hospital — Dalian, China (Not_yet_recruiting)
• Guangdong Province Hospital — Guangzhou, China (Not_yet_recruiting)
• Sir Run Run Shaw Hospital of Zhejiang University School of Medicine — Hangzhou, China (Not_yet_recruiting)
• The First Affiliated Hospital of Zhejiang University school of medicine — Hangzhou, China (Not_yet_recruiting)
• Zhejiang Provincial People's Hospital — Hangzhou, China (Not_yet_recruiting)
• Jinan Central Hospital — Jinan, China (Not_yet_recruiting)
• Jiangsu Province Hospital — Nanjing, China (Not_yet_recruiting)
• Nanjing Drum Tower Hospital — Nanjing, China (Not_yet_recruiting)
• Huashan Hospital Fudan University — Shanghai, China (Not_yet_recruiting)
• Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine — Shanghai, China (Not_yet_recruiting)
• Shanghai General Hospital — Shanghai, China (Not_yet_recruiting)
• The Zhongshan Hospital Affiliated to Fudan University — Shanghai, China (Recruiting)
• The First Affiliated Hospital of Soochow University — Suzhou, China (Not_yet_recruiting)
• Tianjin General Hospital — Tianjin, China (Not_yet_recruiting)
• Renmin Hospital of Wuhan University — Wuhan, China (Not_yet_recruiting)
• Wuxi People's Hospital — Wuxi, China (Not_yet_recruiting)
• Shaanxi Provincial People's Hospital — Xi'an, China (Not_yet_recruiting)
• The First Affiliated Hospital of Xian Jiaotong University — Xi'an, China (Not_yet_recruiting)
• The Second Affiliated Hospital of Xi'an Jiaotong University — Xi'an, China (Not_yet_recruiting)
• The Affiliated Hospital of Xuzhou Medical College — Xuzhou, China (Not_yet_recruiting)

Study contacts

• Study coordinator: Qiang Shi

Conditions Atherosclerosis Cardiovascular Disease; ASCVD; ASCVD Management; ABP-745