Actively Recruiting
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Study to Evaluate the Efficacy, Safety, and Population Pharmacokinetics Profile of ABP-745 in Patients With Atherosclerosis
Led by Atom Therapeutics Co., Ltd · Updated on 2026-04-28
200
Participants Needed
33
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the preliminary efficacy, safety, and population pharmacokinetics (PopPK) of ABP-745 in adults aged 18 to 75 years who have atherosclerotic cardiovascular disease (ASCVD). This randomized, double-blind, placebo-controlled Phase II study aims to compare the ability of ABP-745 to reduce atherosclerotic plaque against a placebo. The primary measurement of efficacy will be the change in percent atheroma volume (PAV) after 52 weeks of treatment. Participants will be randomly assigned to one of four groups: placebo or one of three different doses of ABP-745 tablets taken orally once daily. Throughout the study, existing lipid-lowering maintenance medications will remain unchanged. The study includes a 52-week treatment period, after which the primary outcome will be assessed. Safety and tolerability will also be monitored up to 14 days after the last dose. During the study, participants will continue their current oral lipid-lowering therapy and attend regular visits for assessments including physical exams, vital signs, laboratory tests, and ECGs. Researchers will measure changes in atherosclerotic plaque volume and monitor for adverse events. The total duration of participation includes the 52-week treatment period plus safety follow-up, with detailed monitoring to evaluate the impact and safety of ABP-745 in this population.
CONDITIONS
Brief Title
Efficacy, Safety, and PopPK Profile of ABP-745 in Patients With Atherosclerosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with coronary atherosclerosis confirmed by coronary angiography
- Male or female aged 18 to 75 years inclusive
- Weight of 40 kg or more
- Currently using any oral lipid-lowering therapy
- Able to understand and willing to sign informed consent and comply with study requirements
- Women or men of childbearing potential agreeing to use approved contraceptive methods from screening until 3 months after last study dose
You will not qualify if you...
- 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 screening
- Major surgery within 3 months prior to screening or planned major surgery during the study
- Presence or suspicion of any serious ongoing infection
- Human immunodeficiency virus (HIV) infection
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 52 weeks
Participants receive daily tablets of ABP-745 or placebo while continuing their existing lipid-lowering medications.
Weekly visits for up to 52 weeks
Duration - Up to 14 days post the last dose of study drug
Participants are monitored for safety and any adverse events after completing the treatment.
1 to 2 visits depending on safety assessments
Trial Site Locations
Total: 33 locations
1
Cardiovascular Research Foundation of Southern California
Beverly Hills, California, United States, 90210
Not Yet Recruiting
2
Cardiovascular Institute of San Diego INC
San Diego, California, United States, 91911
Not Yet Recruiting
3
The Lundquist Institute
Torrance, California, United States, 90502
Not Yet Recruiting
4
Washington University School of Medicine, St.louis
St Louis, Missouri, United States, 63130
Not Yet Recruiting
5
NovaTrails
Newcastle, New South Wales, Australia, 2290
Not Yet Recruiting
6
University of the Sunshine Coast Clinical Trials Unit - Morayfield
Morayfield, Queensland, Australia, 4506
Not Yet Recruiting
7
Core Research Group Pty Ltd
Brisbane, Australia
Not Yet Recruiting
8
UniSC Clinical Trials (Brisbane)
Brisbane, Australia
Not Yet Recruiting
9
Cognivus
Wahroonga, Australia
Not Yet Recruiting
10
Beijing Friendship Hospital, Capital Medical University
Beijing, China
Not Yet Recruiting
11
Peking Union Medical College Hospital
Beijing, China
Not Yet Recruiting
12
Peking University First Hospital
Beijing, China
Not Yet Recruiting
13
Xuanwu Hospital Capital Medical University
Beijing, China
Not Yet Recruiting
14
Dalian Second Hospital
Dalian, China
Not Yet Recruiting
15
Guangdong Province Hospital
Guangzhou, China
Not Yet Recruiting
16
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
Hangzhou, China
Not Yet Recruiting
17
The First Affiliated Hospital of Zhejiang University school of medicine
Hangzhou, China
Not Yet Recruiting
18
Zhejiang Provincial People's Hospital
Hangzhou, China
Not Yet Recruiting
19
Jinan Central Hospital
Jinan, China
Not Yet Recruiting
20
Jiangsu Province Hospital
Nanjing, China
Not Yet Recruiting
21
Nanjing Drum Tower Hospital
Nanjing, China
Not Yet Recruiting
22
Huashan Hospital Fudan University
Shanghai, China
Not Yet Recruiting
23
Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, China
Not Yet Recruiting
24
Shanghai General Hospital
Shanghai, China
Not Yet Recruiting
25
The Zhongshan Hospital Affiliated to Fudan University
Shanghai, China
Actively Recruiting
26
The First Affiliated Hospital of Soochow University
Suzhou, China
Not Yet Recruiting
27
Tianjin General Hospital
Tianjin, China
Not Yet Recruiting
28
Renmin Hospital of Wuhan University
Wuhan, China
Not Yet Recruiting
29
Wuxi People's Hospital
Wuxi, China
Not Yet Recruiting
30
Shaanxi Provincial People's Hospital
Xi'an, China
Not Yet Recruiting
31
The First Affiliated Hospital of Xian Jiaotong University
Xi'an, China
Not Yet Recruiting
32
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, China
Not Yet Recruiting
33
The Affiliated Hospital of Xuzhou Medical College
Xuzhou, China
Not Yet Recruiting
Research Team
Q
Qiang Shi
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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