NCT07303777

Efficacy, Safety, and PopPK Profile of ABP-745 in Patients With Atherosclerosis

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Atom Therapeutics Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atherosclerosis Cardiovascular Disease
• ASCVD
• ASCVD Management

Interventions

Type	Name	Description
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

Timeline

• Start date: 2026-04-01
• Primary completion: 2028-01-01
• Completion: 2028-04-01
• First posted: 2025-12-26
• Last updated: 2026-04-09

Locations

33 sites across 3 countries: United States, Australia, China

Regulatory

• FDA-regulated drug study