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

Last updated: April 6, 2026
Sponsor: NewAmsterdam Pharma
Overall Status: Active - Not Recruiting

Phase

3

Condition

Coronary Artery Disease

Vascular Diseases

Cardiac Disease

Treatment

obicetrapib 10 mg + ezetimibe 10 mg FDC daily

Placebo

Clinical Study ID

NCT06305559
OBEZ-302
  • Ages > 45
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

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 coronaryarteries

  • BMI 18-40, inclusive

  • Max tolerated lipid modifying therapy

  • Estimated glomerular filtration rate ≥40 mL/min/1.73 m2

Exclusion

Exclusion Criteria:

  • HbA1c ≥10.0% (≥0.100 hemoglobin fraction) or a fasting glucose ≥270 mg/dL (≥15.0mmol/L) at Screening

  • Contraindications for CCTA

  • History of coronary artery bypass graft

  • Active liver disease

Study Design

Total Participants: 300
Treatment Group(s): 2
Primary Treatment: obicetrapib 10 mg + ezetimibe 10 mg FDC daily
Phase: 3
Study Start date:
May 16, 2024
Estimated Completion Date:
February 29, 2028

Connect with a study center

  • NGMR

    Hialeah, Florida 33016
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.