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

Phase 3Active Not RecruitingNCT06305559

NewAmsterdam Pharma300 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

300

Conditions

Lipidemia Coronary Artery Disease Plaque, Atherosclerotic

Interventions

Eligibility

Sex: ALLMin age: 45 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

• To evaluate the effect of obicetrapib 10 mg + ezetimibe 10 mg fixed dose combination (FDC) daily on total non-calcified coronary atherosclerotic plaque volume (NCPV) at 18 months.

Total plaque comparison measured by CCTA

Time frame: 18 months

Secondary Outcomes

Absolute change from baseline to 18 months in total NCPV in all major epicardial coronary arteries, as measured by CCTA, in participants treated with obicetrapib 10 mg + ezetimibe 10 mg FDC therapy compared with placebo.

Total change in NCPV as measured by CCTA

Time frame: 18 Months

Percent change from baseline to 18 months in LDL-C in participants treated with obicetrapib 10 mg + ezetimibe 10 mg FDC therapy compared to placebo.

Change in LDL-C levels measured by central lab

Time frame: 18 Months

Percent change from baseline to 18 months in non-calcified coronary atherosclerotic plaque volume in the most diseased coronary segment (NCPVMD), as measured by CCTA, in participants treated with FDC therapy vs placebo

Percent change in plaque volume in most diseased coronary arteries measured by CCTA

Time frame: 18 Months

Absolute change from baseline to 18 months in NCPVMD, as measured by CCTA, in participants treated with obicetrapib 10 mg + ezetimibe 10 mg FDC therapy compared with placebo.

Absolute change in plaque volume in most diseased coronary arteries measured by CCTA

Time frame: 18 Months

Change in perivascular fat attenuation index (FAI), FAI score and its age- and gender specific centile in the principal epicardial coronary arteries as measured by CCTA in participants treated with FDC therapy compared with placebo.

Changes in coronary arterial fat composition measured by CCTA

Time frame: 18 Months

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes