Study of Obicetrapib & Ezetimibe Fixed Dose Combination on Top of Maximum Tolerated Lipid-Modifying Therapies
Completed · Phase 3 · Has a placebo group
Conditions studied: Dyslipidemias, Hypercholesterolemia, Familial Hypercholesterolemia, ASCVD, High Cholesterol
In brief
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) or multiple ASCVD risk factors to evaluate the efficacy, safety and tolerability of obicetrapib 10mg and ezetimibe 10mg fixed dose combination as an adjunct to diet and maximally tolerated lipid-lowering therapy.
Key facts
- Study ID
- NCT06005597
- Run by
- NewAmsterdam Pharma
- People needed
- 407
- Starts
- 2024-03-01
- Expected to finish
- 2024-10-16
- Last updated by the study team
- 2025-10-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- East Valley Diabetes & Endocrinology — Gilbert, Arizona, United States
- Jacksonville Center for Clinical Research — Jacksonville, Florida, United States
- Progressive Medical Research — Port Orange, Florida, United States
- Centricity Research - Columbus — Columbus, Georgia, United States
- Center for Advanced Research and Education — Gainesville, Georgia, United States
- NSC Research — Johns Creek, Georgia, United States
- North Georgia Clinical Research — Woodstock, Georgia, United States
- Evanston Premier Healthcare Research LLC — Skokie, Illinois, United States
- Cardiovascular Research of Northwest Indiana, LLC — Munster, Indiana, United States
- Grace Research, LLC - Bossier City, LA — Bossier City, Louisiana, United States
- Horizon Research Group of Opelousas — Eunice, Louisiana, United States
- Maryland Cardiovascular Specialists — Baltimore, Maryland, United States
- TidalHealth Peninsula Regional, Inc. — Salisbury, Maryland, United States
- McClaren Bay Heart and Vascular — Bay City, Michigan, United States
- Northern Pines Health Center — Buckley, Michigan, United States
- Sparrow Clinical Research Institute — Lansing, Michigan, United States
- Oakland Medical Research Center — Troy, Michigan, United States
- CentraCare Heart & Vascular Center — Saint Cloud, Minnesota, United States
- North Mississippi Medical Center — Tupelo, Mississippi, United States
- St. Louis Heart and Vascular Cardiology — St Louis, Missouri, United States
- Washington University School of Medicine — St Louis, Missouri, United States
- Triad Internal Medicine — Asheboro, North Carolina, United States
- Cary Research Group, LLC — Cary, North Carolina, United States
- Novant Health Clinical Research, LLC — Charlotte, North Carolina, United States
- Novant Health Heart and Vascular Institute — Charlotte, North Carolina, United States
Full record on ClinicalTrials.gov
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