A CCTA Imaging Trial to Evaluate the Effect of Obicetrapib/Ezetimibe on Coronary Plaque

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-16

Study Completion Date

2027-03-31

Brief Summary

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This placebo-controlled, double-blind, randomized, Phase 3 study is being conducted in adult participants with high-risk atherosclerotic cardiovascular disease (ASCVD) who are not adequately controlled by their maximally tolerated lipid-modifying therapy, to assess the impact of the obicetrapib 10 mg + ezetimibe 10 mg FDC daily on coronary plaque and inflammation characteristics, evaluated using cardiovascular computed tomography angiography (CCTA).

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Detailed Description

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Conditions

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Lipidemia Coronary Artery Disease Plaque, Atherosclerotic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Double blind set-up; post randomization LDL values are not provided to sites (alert triggers are programmed for urgent follow-up)

Study Groups

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Obicetrapib/Ezetimibe

obicetrapib 10 mg + ezetimibe 10 mg FDC daily

Group Type EXPERIMENTAL

obicetrapib 10 mg + ezetimibe 10 mg FDC daily

Intervention Type DRUG

Active treatment

Placebo

Placebo on top of baseline lipid modifying therapy

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Baseline lipid modifying therapy

Interventions

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obicetrapib 10 mg + ezetimibe 10 mg FDC daily

Active treatment

Intervention Type DRUG

Placebo

Baseline lipid modifying therapy

Intervention Type OTHER

Other Intervention Names

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FDC

Eligibility Criteria

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Inclusion Criteria

* Fasting serum LDL-C ≥70 mg/dL (≥1.81 mmol/L)
* Evaluable non-calcified plaque of at least 75 mm3 in the major epicardial coronary arteries
* BMI 18-40, inclusive
* Max tolerated lipid modifying therapy
* Estimated glomerular filtration rate ≥40 mL/min/1.73 m2

Exclusion Criteria

* HbA1c ≥10.0% (≥0.100 hemoglobin fraction) or a fasting glucose ≥270 mg/dL (≥15.0 mmol/L) at Screening
* Contraindications for CCTA
* History of coronary artery bypass graft
* Active liver disease

Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No