Efficacy, Safety, and PopPK Profile of ABP-745 in Patients With Atherosclerosis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAtom Therapeutics Co., Ltd
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- ABP-745 Dose A
- Placebo
- ABP-745 Dose B
- ABP-745 Dose C
Treatment groups
200 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov