Cardiovascular Outcome Study to Evaluate the Effect of Obicetrapib in Patients With Cardiovascular Disease

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Atherosclerotic Cardiovascular Disease

In brief

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.

Key facts

Study ID

NCT05202509

Run by

NewAmsterdam Pharma

People needed

9541

Starts

2022-02-07

Expected to finish

2026-11-01

Last updated by the study team

2024-06-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males \& females ≥ 18 years age.
• Established ASCVD including:
• Coronary artery disease
• Cerebrovascular disease
• Peripheral Artery disease
• On maximally tolerated lipid-modifying therapy
• Fasting LDL-C ≥ 55 mg/dL
• Fasting triglycerides < 400 mg/dL
• Estimated glomerular filtration rate ≥ 30 mL/min

You may not qualify if…

• New York Heart Association class III or IV heart failure or left ventricular ejection fraction < 30%
• Have been hospitalized for Heart Failure within 5 years prior to screening
• Had non-fatal MI, non-fatal stroke, non-elective coronary revascularization and/or hospitalization for unstable angina or chest pain within past 3 months prior to screening
• Uncontrolled hypertension
• Diagnosis of homozygous familial hypercholesterolemia (HoFH)
• Active liver disease
• HbA1c ≥10%
• Thyroid Stimulating Hormone (TSH) > 1.5 times upper limit normal
• Creatine kinase > 3 times upper limit normal
• History of malignancy with surgery in past 3 years
• History of alcohol or drug abuse within past 5 years
• Received treatment with investigational product or device within past 30 days excluding Coronavirus treatment or vaccine
• Known allergy to study drug
• Participated in previous obicetrapib trial
• Taking gemfibrozil within 30 days screening

Where it is running

• Ascension - Cardiology Specialists of Birmingham — Birmingham, Alabama, United States
• Central Alabama Research — Birmingham, Alabama, United States
• Cardiovascular Associates of the Southeast, LLC — Birmingham, Alabama, United States
• Eastern Shore Research Institute, LLC — Fairhope, Alabama, United States
• The Heart Center Research — Huntsville, Alabama, United States
• Mobile Heart Specialists — Mobile, Alabama, United States
• Syed Research Consultants — Muscle Shoals, Alabama, United States
• Syed Research Consultants — Sheffield, Alabama, United States
• Elite Clinical Studies — Phoenix, Arizona, United States
• Clinical Research Institute of Arizona, LLC — Sun City West, Arizona, United States
• Eclipse Clinical Research — Tucson, Arizona, United States
• NEA Baptist clinic — Jonesboro, Arkansas, United States
• Cardiology and Medicine Clinic — Little Rock, Arkansas, United States
• Advanced Research Center — Anaheim, California, United States
• Westside Medical Associates of Los Angeles — Beverly Hills, California, United States
• Hope Clinical Research LLC — Canoga Park, California, United States
• Titan Medical Research - Oceanside — Encinitas, California, United States
• Clinical Trials Research — Lincoln, California, United States
• Torrance Clinical Research Institute Inc. — Lomita, California, United States
• American Institute of Research — Los Angeles, California, United States
• Amicis Research Center-Northridge — Northridge, California, United States
• Amicis Research — Northridge, California, United States
• Valley Clinical Trials, Inc — Northridge, California, United States
• Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center — Torrance, California, United States
• Advanced Cardiovascular LLC — Alexander City, Alabama, United States

Full record on ClinicalTrials.gov

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