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

Phase 3

Recruiting

• Conditions: Lipidemia; Coronary Artery Disease; Plaque, Atherosclerotic
• Interventions: Other: Placebo; Drug: obicetrapib 10 mg + ezetimibe 10 mg FDC daily

• Registration Number: NCT06305559
• Lead Sponsor: NewAmsterdam Pharma

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-28
• Study First Submitted QC: 2024-03-05
• Study First Posted: 2024-03-12
• Study Start: 2024-05-16
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-12
• Last Update Posted: 2024-11-14
• Primary Completion: 2026-12
• Study Completion: 2027-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• LDL >70md/dL
• Total coronary plaque > 75mm3
• BMI 18-40
• Max tolerated lipid modifying therapy
• eGFR greater/equal to 40

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Exclusion Criteria

• HbA1c >10

• Contraindications for CCTA
• History of coronary artery bypass graft
• Active liver disease

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo on top of baseline lipid modifying therapy
Obicetrapib/Ezetimibe	obicetrapib 10 mg + ezetimibe 10 mg FDC daily	obicetrapib 10 mg + ezetimibe 10 mg FDC daily

Primary Outcome Measures

Name	Time	Method
• 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.	18 months	Total plaque comparison measured by CCTA

Secondary Outcome Measures

Name	Time	Method
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.	18 Months	Total change in NCPV as measured by CCTA
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.	18 Months	Change in LDL-C levels measured by central lab
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	18 Months	Percent change in plaque volume in most diseased coronary arteries measured by CCTA
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.	18 Months	Absolute change in plaque volume in most diseased coronary arteries measured by CCTA
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.	18 Months	Changes in coronary arterial fat composition measured by CCTA

Trial Locations

Locations (1)

NGMR; 🇺🇸 Hialeah, Florida, United States