Active — Not RecruitingPhase 3

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

United States300 participantsStarted 2024-05-16

Plain-language 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).

Who can participate

Age range45 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

• 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

Trial details

NCT IDNCT06305559

SponsorNewAmsterdam Pharma

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-11

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