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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 23, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 23, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 23, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 26, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 28, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings