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

Part of paid clinical trials in Hialeah, Florida.

Sponsor
NewAmsterdam Pharma
Study ID
NCT06305559
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Coronary Artery Disease
  • Lipidemia
  • Plaque, Atherosclerotic

Eligibility Criteria

Sex
ALL
Age
45 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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).

Key Dates

Start date
May 16, 2024
Status verified
Apr 2026
Primary completion
Nov 30, 2027
Completion
Feb 29, 2028

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Obicetrapib/Ezetimibe
    obicetrapib 10 mg + ezetimibe 10 mg FDC daily
  • Placebo Comparator: Placebo
    Placebo on top of baseline lipid modifying therapy

Primary Outcome Measure

• 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 ]

Locations (1)

FacilityCityStateZIPSite coordinators
NGMRHialeahFlorida33016-

Find similar trials in Hialeah, FL

By research site
NGMR· Hialeah, FL

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