Efficacy, Safety, and PopPK Profile of ABP-745 in Patients With Atherosclerosis
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
1 other identifier
interventional
200
3 countries
33
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2026
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 23, 2025
CompletedFirst Posted
Study publicly available on registry
December 26, 2025
CompletedStudy Start
First participant enrolled
April 23, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2028
April 28, 2026
December 1, 2025
1.7 years
December 23, 2025
April 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from the baseline in percent atheroma volume (PAV)
52 weeks after treatment
Secondary Outcomes (2)
Change from the baseline in percent atheroma volume (PAV)
24 weeks after treatment
Incidence of treatment-emergent adverse events (Safety and Tolerability) TEAEs and SAEs, and clinically significant changes in physical examination, vital signs, safety laboratory tests, and 12-lead ECG.
up to 14 days post the last dose of study drug
Study Arms (4)
Placebo group
PLACEBO COMPARATORExisting lipid-lowering maintenance medications unchanged.
ABP-745 Dose A
EXPERIMENTALExisting lipid-lowering maintenance medications unchanged.
ABP-745 Dose B
EXPERIMENTALExisting lipid-lowering maintenance medications unchanged.
ABP-745 Dose C
EXPERIMENTALExisting lipid-lowering maintenance medications unchanged.
Interventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (33)
Cardiovascular Research Foundation of Southern California
Beverly Hills, California, 90210, United States
Cardiovascular Institute of San Diego INC
San Diego, California, 91911, United States
The Lundquist Institute
Torrance, California, 90502, United States
Washington University School of Medicine, St.louis
St Louis, Missouri, 63130, United States
NovaTrails
Newcastle, New South Wales, 2290, Australia
University of the Sunshine Coast Clinical Trials Unit - Morayfield
Morayfield, Queensland, 4506, 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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 23, 2025
First Posted
December 26, 2025
Study Start
April 23, 2026
Primary Completion (Estimated)
January 1, 2028
Study Completion (Estimated)
April 1, 2028
Last Updated
April 28, 2026
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share
There is no such demand at present.