Cardiovascular Outcome Study to Evaluate the Effect of Obicetrapib in Patients With Cardiovascular Disease
NCT05202509 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 9541
Last updated 2024-06-04
Summary
This study will be a placebo-controlled, double-blind, randomized, phase 3 study in participants with Atherosclerotic Cardiovascular Disease (ASCVD) who are not adequately controlled despite maximally tolerated lipid-lowering therapy.
Conditions
Interventions
- DRUG
-
Obicetrapib
10mg obicetrapib tablet
- DRUG
-
Placebo tablet to resemble obicetrapib
Sponsors & Collaborators
- collaborator OTHER
-
NewAmsterdam Pharma
lead INDUSTRY
Principal Investigators
-
Marc Ditmarsch, MD · NewAmsterdam Pharma
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-02-07
- Primary Completion
- 2026-11-30
- Completion
- 2026-11-30
- FDA Drug
- Yes
Countries
- United States
- Australia
- Bulgaria
- Canada
- China
- Croatia
- Czechia
- Denmark
- Finland
- Georgia
- Germany
- Hungary
- Israel
- Italy
- Japan
- Jordan
- Latvia
- Netherlands
- Poland
- Slovakia
- South Africa
- Spain
- United Kingdom
Study Locations
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