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

Atom Therapeutics Co., Ltd

Status and phase: Not yet enrolling; Phase 2

Conditions: ASCVD Management; Atherosclerosis Cardiovascular Disease; ASCVD

Treatments: Drug: ABP-745 Dose C; Drug: ABP-745 Dose A; Drug: ABP-745 Dose B; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07303777

ABP-745-202

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Unless otherwise specified, subjects must meet all of the following criteria at screening:

• 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.
• Able to understand and willing to sign an ICF and comply with study requirements.
• A woman or man of childbearing potential agreeing to use medically approved contraceptive methods from the screening until 3 months after the last study dose.

Exclusion criteria

Unless otherwise specified, subjects are excluded from the study if any of the following criteria is met:

• 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.
• Presence or suspicion of ongoing of any serious infection.
• Human immunodeficiency virus (HIV) infection.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 4 patient groups, including a placebo group

Placebo group

Placebo Comparator group

Description:

Existing lipid-lowering maintenance medications unchanged.

Treatment:

Drug: Placebo

ABP-745 Dose A

Experimental group

Description:

Existing lipid-lowering maintenance medications unchanged.

Treatment:

Drug: ABP-745 Dose A

ABP-745 Dose B

Experimental group

Description:

Existing lipid-lowering maintenance medications unchanged.

Treatment:

Drug: ABP-745 Dose B

ABP-745 Dose C

Experimental group

Description:

Existing lipid-lowering maintenance medications unchanged.

Treatment:

Drug: ABP-745 Dose C