Status:
COMPLETED
Study of Obicetrapib & Ezetimibe Fixed Dose Combination on Top of Maximum Tolerated Lipid-Modifying Therapies
Lead Sponsor:
NewAmsterdam Pharma
Conditions:
Dyslipidemias
Hypercholesterolemia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The study is a placebo-controlled, double-blind, randomized, phase 3 study in participants with heterozygous familial hypercholesterolemia (HeFH) and/or atherosclerotic cardiovascular disease (ASCVD) ...
Detailed Description
This study will be a placebo-controlled, double-blind, randomized, phase 3 study in participants with heterozygous familial hypercholesterolemia (HeFH) and/or atherosclerotic cardiovascular disease (A...
Eligibility Criteria
Inclusion
- Have underlying HeFH and/or a history of ASCVD or multiple ASCVD risk factors
- On maximally tolerated lipid-modifying therapy as an adjunct to a diet and lifestyle modifications
- LDL-C ≥ 70 mg/dL
- Triglycerides \< 500
- Estimated glomerular filtration rate ≥ 15 mL/min/1.73 m2
Exclusion
- History of New York Heart Association (NYHA) class III or IV heart failure of left ventricular ejection fraction \<30%
- Hospitalized for heart failure within the last 5 years
- Myocardial infarction, stroke, non-elective coronary revascularization or hospitalization for unstable angina or chest pain in the last 3 months
- Uncontrolled severe hypertension
- Diagnosis of homozygous FH
- Liver disease
- HbA1c ≥ 10.0% or fasting glucose ≥ 270 mg/dL
- Thyroid-stimulating hormone \>1.5 x upper limit of normal (ULN)
- History of malignancy
- Creatinine kinase (CK) \>3 X ULN
- Alcohol abuse
- Treatment with investigational product
- Treatment with gemfibrozil or ezetimibe
- Previous participation in a trial evaluating obicetrapib
- Known allergy to study drugs, placebo or excipients in study drugs of placebo
- Other condition that would interfere with the conduct of the study
Key Trial Info
Start Date :
March 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 16 2024
Estimated Enrollment :
407 Patients enrolled
Trial Details
Trial ID
NCT06005597
Start Date
March 1 2024
End Date
October 16 2024
Last Update
October 8 2025
Active Locations (45)
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1
East Valley Diabetes & Endocrinology
Gilbert, Arizona, United States, 85297
2
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States, 32216
3
Progressive Medical Research
Port Orange, Florida, United States, 32127
4
Centricity Research - Columbus
Columbus, Georgia, United States, 31904