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

April 23, 2026 updated by: Atom Therapeutics Co., Ltd

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 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
      • Brisbane, Australia
        • Not yet recruiting
        • Core Research Group Pty Ltd
        • Principal Investigator:
          • Colquhoun David, M.D.
      • Brisbane, Australia
        • Not yet recruiting
        • UniSC Clinical Trials (Brisbane)
        • Contact:
        • Principal Investigator:
          • Nsahai Sahai, M.D.
      • Wahroonga, Australia
        • Not yet recruiting
        • Cognivus
        • Principal Investigator:
          • Elizabeth Shaw, MBBS
    • New South Wales
      • Newcastle, New South Wales, Australia, 2290
    • Queensland
      • Morayfield, Queensland, Australia, 4506
        • Not yet recruiting
        • University of the Sunshine Coast Clinical Trials Unit - Morayfield
        • Contact:
          • Chris Moller, M.D.
        • Principal Investigator:
          • Chris Moller, M.D.
  • China
      • Beijing, China
        • Not yet recruiting
        • Beijing Friendship Hospital, Capital Medical University
        • Principal Investigator:
          • Ping Wang
      • Beijing, China
        • Not yet recruiting
        • Peking University First Hospital
        • Principal Investigator:
          • Yan Zhang
      • Beijing, China
        • Not yet recruiting
        • Peking Union Medical College Hospital
        • Principal Investigator:
          • Zhenyu Liu
      • Beijing, China
        • Not yet recruiting
        • Xuanwu Hospital Capital Medical University
        • Principal Investigator:
          • Chunlin Yin
      • Dalian, China
        • Not yet recruiting
        • Dalian Second Hospital
        • Principal Investigator:
          • Xin Zhao
      • Guangzhou, China
        • Not yet recruiting
        • Guangdong Province Hospital
        • Principal Investigator:
          • Jiyan Chen
      • Hangzhou, China
        • Not yet recruiting
        • Zhejiang Provincial People's Hospital
        • Principal Investigator:
          • Lihong Wang
      • Hangzhou, China
        • Not yet recruiting
        • The First Affiliated Hospital of Zhejiang University School of Medicine
        • Principal Investigator:
          • Xiaogang Guo
      • Hangzhou, China
        • Not yet recruiting
        • Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
        • Principal Investigator:
          • Guosheng Fu
      • Jinan, China
        • Not yet recruiting
        • Jinan Central Hospital
        • Principal Investigator:
          • guohai Su
      • Nanjing, China
        • Not yet recruiting
        • Jiangsu Province Hospital
        • Principal Investigator:
          • Chunjian Li
      • Nanjing, China
        • Not yet recruiting
        • Nanjing Drum Tower Hospital
        • Principal Investigator:
          • Biao Xu
      • Shanghai, China
        • Not yet recruiting
        • Shanghai General Hospital
        • Principal Investigator:
          • Shaowen Liu
      • Shanghai, China
        • Not yet recruiting
        • Huashan Hospital Fudan University
        • Principal Investigator:
          • Jian Li
      • Shanghai, China
        • Not yet recruiting
        • Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
        • Principal Investigator:
          • Jun Bu
      • Shanghai, China
        • Recruiting
        • The Zhongshan Hospital Affiliated to Fudan University
        • Principal Investigator:
          • Junbo Ge, M.D.
      • Suzhou, China
        • Not yet recruiting
        • The First Affiliated Hospital of Soochow University
        • Principal Investigator:
          • Tingbo Jiang
      • Tianjin, China
        • Not yet recruiting
        • Tianjin General Hospital
        • Principal Investigator:
          • Qing Yang
      • Wuhan, China
        • Not yet recruiting
        • Renmin Hospital of Wuhan University
        • Principal Investigator:
          • Xiaoyan Li
      • Wuxi, China
        • Not yet recruiting
        • Wuxi People's Hospital
        • Principal Investigator:
          • Ruxing Wang
      • Xi'an, China
        • Not yet recruiting
        • The Second Affiliated Hospital of Xi'an Jiaotong University
        • Principal Investigator:
          • Jie Deng
      • Xi'an, China
        • Not yet recruiting
        • The First Affiliated Hospital of Xian Jiaotong University
        • Principal Investigator:
          • Zuyi Yuan
      • Xi'an, China
        • Not yet recruiting
        • Shaanxi Provincial People's Hospital
        • Principal Investigator:
          • Junkui Wang
      • Xuzhou, China
        • Not yet recruiting
        • The Affiliated Hospital of Xuzhou Medical College
        • Principal Investigator:
          • Dengfeng Pan
  • United States
    • California
      • Beverly Hills, California, United States, 90210
        • Not yet recruiting
        • Cardiovascular Research Foundation of Southern California
        • Contact:
        • Principal Investigator:
          • Ronald P. Karlsberg
      • San Diego, California, United States, 91911
        • Not yet recruiting
        • Cardiovascular Institute of San Diego INC
        • Contact:
        • Principal Investigator:
          • Milind Parikh, M.D.
      • Torrance, California, United States, 90502
        • Not yet recruiting
        • The Lundquist Institute
        • Principal Investigator:
          • Matthew Budoff, M.D.
        • Contact:
    • Missouri
      • St Louis, Missouri, United States, 63130
        • Not yet recruiting
        • Washington University School of Medicine, St.louis
        • Contact:
        • Principal Investigator:
          • Farhan M. Katchi, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo group
Existing lipid-lowering maintenance medications unchanged.
Drug: Placebo
ABP-745 placebo - tablets (PO), non-active,QD
Experimental: ABP-745 Dose A
Existing lipid-lowering maintenance medications unchanged.
Drug: ABP-745 Dose A
ABP-745 Dose A - tablets (PO), low dose , QD
Experimental: ABP-745 Dose B
Existing lipid-lowering maintenance medications unchanged.
Drug: ABP-745 Dose B
ABP-745 Dose B - tablets (PO), Midum dose, QD
Experimental: ABP-745 Dose C
Existing lipid-lowering maintenance medications unchanged.
Drug: ABP-745 Dose C
ABP-745 Dose C - tablets (PO), High dose, QD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from the baseline in percent atheroma volume (PAV)
Time Frame: 52 weeks after treatment
52 weeks after treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from the baseline in percent atheroma volume (PAV)
Time Frame: 24 weeks after treatment
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.
Time Frame: up to 14 days post the last dose of study drug
up to 14 days post the last dose of study drug

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Atom Therapeutics Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 23, 2026

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

April 1, 2028

Study Registration Dates

First Submitted

December 23, 2025

First Submitted That Met QC Criteria

December 23, 2025

First Posted (Actual)

December 26, 2025

Study Record Updates

Last Update Posted (Actual)

April 28, 2026

Last Update Submitted That Met QC Criteria

April 23, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ABP-745-202

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no such demand at present.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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