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 — 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

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 group
    Existing lipid-lowering maintenance medications unchanged.
  • Experimental: ABP-745 Dose A
    Existing lipid-lowering maintenance medications unchanged.
  • Experimental: ABP-745 Dose B
    Existing lipid-lowering maintenance medications unchanged.
  • Experimental: ABP-745 Dose C
    Existing 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

Locations (4)

FacilityCityStateZIPSite coordinators
Cardiovascular Research Foundation of Southern CaliforniaBeverly HillsCalifornia90210
Ronald P. Karlsberg
(310) 278-3400
Ronald P. Karlsberg (PRINCIPAL_INVESTIGATOR)
Cardiovascular Institute of San Diego INCSan DiegoCalifornia91911
Milind M. Parikh, M.D.
619-616-2100
Milind Parikh, M.D. (PRINCIPAL_INVESTIGATOR)
The Lundquist InstituteTorranceCalifornia90502
Matthew Budoff, M.D.
(424) 201-3000
Matthew Budoff, M.D. (PRINCIPAL_INVESTIGATOR)
Washington University School of Medicine, St.louisSt LouisMissouri63130
Farhan M. Katchi, M.D.
314-362-1291
Farhan M. Katchi, M.D. (PRINCIPAL_INVESTIGATOR)

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