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NCT Number: NCT07303777

Efficacy, Safety, and 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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

NovaTrails, Newcastle, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ABP-745 Dose A

Drug

ABP-745 Dose A - tablets (PO), low dose , QD

Placebo

Drug

ABP-745 placebo - tablets (PO), non-active,QD

ABP-745 Dose B

Drug

ABP-745 Dose B - tablets (PO), Midum dose, QD

ABP-745 Dose C

Drug

ABP-745 Dose C - tablets (PO), High dose, QD

Primary outcomes

  1. Change from the baseline in percent atheroma volume (PAV)

    Time frame: 52 weeks after treatment

Secondary outcomes

  1. Change from the baseline in percent atheroma volume (PAV)

    Time frame: 24 weeks after treatment

  2. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Qiang Shi

CONTACT

[email protected]

86+ 19117302212

Sponsors and collaborators

Lead sponsor

Atom Therapeutics Co., Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Dec 26, 2025
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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