ABP-745 to reduce atherosclerotic plaque in people with ASCVD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, randomized, double-blind, placebo-controlled Phase 2 trial comparing three dose levels of ABP-745 against placebo in adults with atherosclerotic cardiovascular disease. Participants will remain on their routine oral lipid-lowering therapy and be randomized to one of four arms (three ABP-745 doses or placebo). The study will collect safety data, population pharmacokinetics (PopPK), and imaging-based measures of atherosclerotic plaque, with the primary efficacy measurement at 52 weeks of treatment. Clinical visits and assessments will track adverse events and plaque changes over the treatment period.

Why it matters

Who can join: the full rules

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.

Where it's running

• The Zhongshan Hospital Affiliated to Fudan University
  Shanghai, China Recruiting
• Cardiovascular Research Foundation of Southern California
  Beverly Hills, California, United States Not yet recruiting
• Cardiovascular Institute of San Diego INC
  San Diego, California, United States Not yet recruiting
• The Lundquist Institute
  Torrance, California, United States Not yet recruiting
• Washington University School of Medicine, St.louis
  St Louis, Missouri, United States Not yet recruiting
• NovaTrails
  Newcastle, New South Wales, Australia Not yet recruiting

Study contacts

• Study coordinator: Qiang Shi
• Email: qiang.shi@atombp.com
• Phone: 86+ 19117302212

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Blocking IL-1β to reduce artery inflammation in people with coronary artery disease, including those with TET2 clonal hematopoiesis

  This trial will see if canakinumab, a drug that blocks IL‑1β, reduces artery inflammation in adults with prior heart attack or coronary stents, some of whom have TET2 clonal hematopoiesis.

  Recruiting Phase 2 Massachusetts General Hospital · Boston, Massachusetts · NCT06691217

• Understanding heart artery disease using biomarkers and imaging in Oxford

  Researchers in Oxford are testing how biomarkers and advanced imaging can help explain why some heart artery plaques are unstable and how this affects heart damage after a heart attack.

  Recruiting University of Oxford · Oxford · NCT07772570

• Isometric resistance exercise for atherosclerosis in hypertension

  This study tests whether isometric resistance exercise, like wall squats, can improve markers of atherosclerosis in adults with high blood pressure.

  Recruiting Chinese University of Hong Kong · Shatin · NCT07665034

• Optimizing non-statin cholesterol medicines for people with ASCVD

  This project tests whether coordinated pharmacist support and changes to non-statin cholesterol medicines help people with ASCVD reach their LDL cholesterol goals.

  Recruiting University of Texas at Austin · Austin, Texas · NCT07464574

• How moderate wine drinking affects healthy aging through post-meal extracellular vesicles

  This test will see if a single serving of red or white wine changes circulating extracellular vesicles in healthy adults aged 35–65.

  Recruiting University of Seville · Seville, Sevilla · NCT07361887

• Mouth bacteria and carotid artery plaque vulnerability

  This project will see if mouth bacteria are linked to vulnerable carotid plaques in adults having carotid endarterectomy at Semmelweis University.

  Recruiting Semmelweis University Heart and Vascular Center · Budapest · NCT07296965

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.