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

ConditionsAtherosclerosis Cardiovascular DiseaseASCVDASCVD Management
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

200 Participants
are divided into 4 treatment groups
Group A: Placebo groupPlacebo comparator 1 intervention
Group B: ABP-745 Dose AExperimental treatment 1 intervention
Group C: ABP-745 Dose BExperimental treatment 1 intervention
Group D: ABP-745 Dose CExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change from the baseline in percent atheroma volume (PAV)

Time frame
52 weeks after treatment

Secondary outcomes

1

Change from the baseline in percent atheroma volume (PAV)

Time frame
24 weeks after treatment
2

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

Other outcomes

Sponsors and contacts

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Atom Therapeutics Co., Ltd

Lead sponsor

Source ClinicalTrials.gov
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