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

NewAmsterdam Pharma

Status and phase: Enrolling; Phase 3

Conditions: Coronary Artery Disease; Lipidemia; Plaque, Atherosclerotic

Treatments: Drug: obicetrapib 10 mg + ezetimibe 10 mg FDC daily; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06305559

OBEZ-302

Details and patient eligibility

About

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).

Enrollment: 300 estimated patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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300 participants in 2 patient groups, including a placebo group

Obicetrapib/Ezetimibe

Experimental group

Description:

obicetrapib 10 mg + ezetimibe 10 mg FDC daily

Treatment:

Drug: obicetrapib 10 mg + ezetimibe 10 mg FDC daily

Placebo

Placebo Comparator group

Description:

Placebo on top of baseline lipid modifying therapy

Treatment:

Other: Placebo