Clinical trial NCT06305559: A CCTA Imaging Trial to Evaluate the Effect of Obicetrapib/Ezetimibe on Coronary Plaque
Official title: A Placebo-controlled, Double-blind, Randomized, Phase 3 Study to Evaluate the Effect of Obicetrapib/Ezetimibe Fixed Dose Combination Daily on Coronary Plaque Characteristics in Participants With Atherosclerotic Cardiovascular Disease on Coronary CT Angiography (REMBRANDT Trial)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Lipidemia
Coronary Artery Disease
Plaque, Atherosclerotic
Lead sponsor: NewAmsterdam Pharma
Sponsor class: INDUSTRY
First posted: 2024-03-12
Enrollment: 300
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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).


Eligibility criteria: 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

Primary outcomes:
measure: • 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.
timeFrame: 18 months
Secondary outcomes:
measure: 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.
timeFrame: 18 Months
measure: 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.
timeFrame: 18 Months
measure: 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
timeFrame: 18 Months
measure: 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.
timeFrame: 18 Months
measure: 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.
timeFrame: 18 Months
Other outcomes:
Locations:
city: Hialeah
country: United States
facility: NGMR
state: Florida
Study officials:
References: