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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
200
ABP-745 Dose A - tablets (PO), low dose , QD
ABP-745 placebo - tablets (PO), non-active,QD
ABP-745 Dose B - tablets (PO), Midum dose, QD
Change from the baseline in percent atheroma volume (PAV)
Time frame: 52 weeks after treatment
Change from the baseline in percent atheroma volume (PAV)
Time frame: 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.
Time frame: up to 14 days post the last dose of study drug
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ABP-745 Dose C - tablets (PO), High dose, QD
Cardiovascular Research Foundation of Southern California
Beverly Hills, California, United States
Cardiovascular Institute of San Diego INC
San Diego, California, United States
The Lundquist Institute
Torrance, California, United States
Washington University School of Medicine, St.louis
St Louis, Missouri, United States
NovaTrails
Newcastle, New South Wales, Australia
University of the Sunshine Coast Clinical Trials Unit - Morayfield
Morayfield, Queensland, Australia
Core Research Group Pty Ltd
Brisbane, Australia
UniSC Clinical Trials (Brisbane)
Brisbane, Australia
Cognivus
Wahroonga, Australia
Beijing Friendship Hospital, Capital Medical University
Beijing, China
...and 23 more locations