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Efficacy, Safety, and PopPK Profile of ABP-745 in Patients With Atherosclerosis
Sponsor: Atom Therapeutics Co., Ltd
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2026-04
Completion Date
2028-04
Last Updated
2026-04-09
Healthy Volunteers
No
Interventions
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
Locations (33)
Cardiovascular Research Foundation of Southern California
Beverly Hills, California, United States
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 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