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NCT Number: NCT06305559

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

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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This study is active but is not currently recruiting participants.

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Key information

Conditions

Lipidemia Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Dyslipidemias Heart Diseases Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Myocardial Ischemia Nutritional and Metabolic Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Plaque, Atherosclerotic Vascular Diseases

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

NGMR

Hialeah, Florida, 33016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

obicetrapib 10 mg + ezetimibe 10 mg FDC daily

Drug

Active treatment

Other names: FDC

Placebo

Other

Baseline lipid modifying therapy

Primary outcomes

  1. • 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.

    Time frame: 18 months

    Total plaque comparison measured by CCTA

Secondary outcomes

  1. 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.

    Time frame: 18 Months

    Total change in NCPV as measured by CCTA

  2. 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.

    Time frame: 18 Months

    Change in LDL-C levels measured by central lab

  3. 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

    Time frame: 18 Months

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

  4. 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.

    Time frame: 18 Months

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

  5. 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.

    Time frame: 18 Months

    Changes in coronary arterial fat composition measured by CCTA

Sponsors and collaborators

Lead sponsor

NewAmsterdam Pharma

Industry

Registry information

Official study 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)

Acronym: REMBRANDT

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Mar 12, 2024
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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