NCT07303777 · Atom Therapeutics Co., Ltd
Efficacy, Safety, and PopPK Profile of ABP-745 in Patients With Atherosclerosis
What this study is about
This is a conducted at multiple hospitals, randomly assigned, where neither patients nor doctors know which treatment is given, placebo parallel controlled study to evaluate the preliminary effectiveness, safety, and PopPK profile of ABP-745 in patients with ASCVD. effectiveness of ABP-745 in reducing atherosclerotic plaque compared with placebo will be evaluated in participants with ASCVD.
View original scientific description
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.
Interventions
DRUG
ABP-745 Dose A
ABP-745 Dose A - tablets (PO), low dose , QD
DRUG
Placebo
ABP-745 placebo - tablets (PO), non-active,QD
DRUG
ABP-745 Dose B
ABP-745 Dose B - tablets (PO), Midum dose, QD
DRUG
ABP-745 Dose C
ABP-745 Dose C - tablets (PO), High dose, QD
Primary outcome measures
Change from the baseline in percent atheroma volume (PAV)
Time frame: 52 weeks after treatment
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Beverly Hills, California
- San Diego, California
- Torrance, California
- St Louis, Missouri
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 28, 2026 · Source of record for eligibility and locations