Efficacy, Safety, and PopPK Profile of ABP-745 in Patients With Atherosclerosis
Part of paid clinical trials in Beverly Hills, California.
- Sponsor
- Atom Therapeutics Co., Ltd
- Study ID
- NCT07303777
- Phase
- PHASE2
- Status
- Recruiting
Conditions
- ASCVD
- ASCVD Management
- Atherosclerosis Cardiovascular Disease
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- ABP-745 Dose A — DRUGABP-745 Dose A - tablets (PO), low dose , QD
- Placebo — DRUGABP-745 placebo - tablets (PO), non-active,QD
- ABP-745 Dose B — DRUGABP-745 Dose B - tablets (PO), Midum dose, QD
- ABP-745 Dose C — DRUGABP-745 Dose C - tablets (PO), High dose, QD
Study Details
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.
Key Dates
- Start date
- Apr 23, 2026
- Status verified
- Dec 2025
- Primary completion
- Jan 31, 2028
- Completion
- Apr 30, 2028
Study Design
- Enrollment
- 200 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Placebo Comparator: Placebo groupExisting lipid-lowering maintenance medications unchanged.
- Experimental: ABP-745 Dose AExisting lipid-lowering maintenance medications unchanged.
- Experimental: ABP-745 Dose BExisting lipid-lowering maintenance medications unchanged.
- Experimental: ABP-745 Dose CExisting lipid-lowering maintenance medications unchanged.
Primary Outcome Measure
Change from the baseline in percent atheroma volume (PAV) [ Time Frame: 52 weeks after treatment ]
Central Contacts
- Qiang Shi86+ 19117302212
Locations (4)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Cardiovascular Research Foundation of Southern California | Beverly Hills | California | 90210 | Ronald P. Karlsberg (PRINCIPAL_INVESTIGATOR) |
| Cardiovascular Institute of San Diego INC | San Diego | California | 91911 | Milind Parikh, M.D. (PRINCIPAL_INVESTIGATOR) |
| The Lundquist Institute | Torrance | California | 90502 | Matthew Budoff, M.D. (PRINCIPAL_INVESTIGATOR) |
| Washington University School of Medicine, St.louis | St Louis | Missouri | 63130 | Farhan M. Katchi, M.D. (PRINCIPAL_INVESTIGATOR) |
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