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

Coronary Artery Disease Clinical Trial

— REMBRANDT  

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06305559
• Other study ID #: OBEZ-302
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: March 2024
• Est. completion date: March 2027

Study information

• Verified date: February 2024
• Source: NewAmsterdam Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: March 2027
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

Inclusion Criteria:

• LDL >70md/dL
• Total coronary plaque > 75mm3
• BMI 18-40
• Max tolerated lipid modifying therapy
• eGFR greater/equal to 40 Exclusion Criteria: - HbA1c >10
• Contraindications for CCTA
• History of coronary artery bypass graft
• Active liver disease

Related Conditions & MeSH terms

• Coronary Artery Disease
• Hyperlipidemias
• Lipidemia
• Plaque, Atherosclerotic

Intervention

Drug:
• obicetrapib 10 mg + ezetimibe 10 mg FDC daily
Active treatment

Other:
• Placebo
Baseline lipid modifying therapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
NewAmsterdam Pharma

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	• 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	18 months
Secondary	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	18 Months
Secondary	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	18 Months
Secondary	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	18 Months
Secondary	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	18 Months
Secondary	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	18 Months