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Recruiting Phase 2

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

NCT07303777 · tracked via the Priya Life Science USA tracker
Sponsor
Atom Therapeutics Co., Ltd
Phase
Phase 2
Started
2026-04-23
Last updated
2026-04-28

Condition(s) studied

Atherosclerosis Cardiovascular DiseaseASCVDASCVD Management

Investigational drug(s) / intervention(s)

ABP-745 Dose APlaceboABP-745 Dose BABP-745 Dose C

ABP-745 Dose A: ABP-745 Dose A - tablets (PO), low dose , QD

Placebo: ABP-745 placebo - tablets (PO), non-active,QD

ABP-745 Dose B: ABP-745 Dose B - tablets (PO), Midum dose, QD

ABP-745 Dose C: ABP-745 Dose C - tablets (PO), High dose, QD

Study 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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Change from the baseline in percent atheroma volume (PAV) — 52 weeks after treatment

Trial sites (33)

FacilityCityRegionStatus
Cardiovascular Research Foundation of Southern California Beverly Hills California Not Yet Recruiting
Cardiovascular Institute of San Diego INC San Diego California Not Yet Recruiting
The Lundquist Institute Torrance California Not Yet Recruiting
Washington University School of Medicine, St.louis St Louis Missouri Not Yet Recruiting
NovaTrails Newcastle New South Wales Not Yet Recruiting
University of the Sunshine Coast Clinical Trials Unit - Morayfield Morayfield Queensland 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
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07303777 on ClinicalTrials.gov ↗ ← All trials in the USA