MedDataX Logo

A Phase II Study to Evaluate the Efficacy, Safety, and PopPK Profile of ABP-745 in Patients With Atherosclerosis

NCT ID: NCT07303777

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-28

Study Completion Date

2028-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Atherosclerosis Cardiovascular Disease ASCVD ASCVD Management

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

ASCVD ABP-745

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Placebo group

Existing lipid-lowering maintenance medications unchanged.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

ABP-745 placebo - tablets (PO)

ABP-745 Dose A

Existing lipid-lowering maintenance medications unchanged.

Group Type EXPERIMENTAL

ABP-745 Dose A

Intervention Type DRUG

ABP-745 Dose A - tablets (PO)

ABP-745 Dose B

Existing lipid-lowering maintenance medications unchanged.

Group Type EXPERIMENTAL

ABP-745 Dose B

Intervention Type DRUG

ABP-745 Dose B - tablets (PO)

ABP-745 Dose C

Existing lipid-lowering maintenance medications unchanged.

Group Type EXPERIMENTAL

ABP-745 Dose C

Intervention Type DRUG

ABP-745 Dose C - tablets (PO)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ABP-745 Dose A

ABP-745 Dose A - tablets (PO)

Intervention Type DRUG

Placebo

ABP-745 placebo - tablets (PO)

Intervention Type DRUG

ABP-745 Dose B

ABP-745 Dose B - tablets (PO)

Intervention Type DRUG

ABP-745 Dose C

ABP-745 Dose C - tablets (PO)

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Atom Therapeutics Co., Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The Lundquist Institute

Torrance, California, United States

Site Status

Core Research Group Pty Ltd

Brisbane, , Australia

Site Status

Cognivus

Wahroonga, , Australia

Site Status

The Zhongshan Hospital Affiliated to Fudan University

Shanghai, , China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Australia China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

MaoE Sun

Role: CONTACT

Phone: 86+ 13914017855

Email: [email protected]

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ABP-745-202

Identifier Type: -

Identifier Source: org_study_id