NCT07303777
Recruiting
Phase 2
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
Atom Therapeutics Co., Ltd37 sites in 3 countries200 target enrollmentStarted: April 23, 2026Last updated:
Overview
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Atom Therapeutics Co., Ltd
- Enrollment
- 200
- Locations
- 37
- Primary Endpoint
- Change from the baseline in percent atheroma volume (PAV)
Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Placebo group
Placebo Comparator
Existing lipid-lowering maintenance medications unchanged.
Intervention: Placebo (Drug)
ABP-745 Dose A
Experimental
Existing lipid-lowering maintenance medications unchanged.
Intervention: ABP-745 Dose A (Drug)
ABP-745 Dose B
Experimental
Existing lipid-lowering maintenance medications unchanged.
Intervention: ABP-745 Dose B (Drug)
ABP-745 Dose C
Experimental
Existing lipid-lowering maintenance medications unchanged.
Intervention: ABP-745 Dose C (Drug)
Outcomes
Primary Outcomes
Change from the baseline in percent atheroma volume (PAV)
Time Frame: 52 weeks after treatment
Secondary Outcomes
- Change from the baseline in percent atheroma volume (PAV)(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.(up to 14 days post the last dose of study drug)
Investigators
Study Sites (37)
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