Status:
ACTIVE_NOT_RECRUITING
Cardiovascular Outcome Study to Evaluate the Effect of Obicetrapib in Patients With Cardiovascular Disease
Lead Sponsor:
NewAmsterdam Pharma
Collaborating Sponsors:
Monash University
Conditions:
Atherosclerotic Cardiovascular Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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...
Detailed Description
This study will be a placebo-controlled, double-blind, randomized, phase 3 study to evaluate the effect of 10mg Obicetrapib in participants with Atherosclerotic Cardiovascular Disease (ASCVD) who are ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
February 7 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2026
Estimated Enrollment :
9541 Patients enrolled
Trial Details
Trial ID
NCT05202509
Start Date
February 7 2022
End Date
November 1 2026
Last Update
June 4 2024
Active Locations (591)
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1
Advanced Cardiovascular LLC
Alexander City, Alabama, United States, 35010
2
Ascension - Cardiology Specialists of Birmingham
Birmingham, Alabama, United States, 35205
3
Central Alabama Research
Birmingham, Alabama, United States, 35209
4
Cardiovascular Associates of the Southeast, LLC
Birmingham, Alabama, United States, 35243