Study to Evaluate the Effect of Obicetrapib in Combination With Ezetimibe as an Adjunct to HIS Therapy
Completed · Phase 2 · Has a placebo group
Conditions studied: Dyslipidemias, High Cholesterol, Hypercholesterolemia
In brief
This study will be a placebo-controlled, double-blind, randomized, phase 2 study to evaluate the efficacy, safety, and tolerability of obicetrapib 10 mg, both in combination with ezetimibe 10 mg and as monotherapy, as an adjunct to high-intensity statin therapy.
Key facts
- Study ID
- NCT05266586
- Run by
- NewAmsterdam Pharma
- People needed
- 119
- Starts
- 2022-03-09
- Expected to finish
- 2022-09-08
- Last updated by the study team
- 2024-07-03
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- LDL-C > 70 mg/dL and Triglycerides < 400 mg/dL,
- Treated with a high-intensity statin therapy
You may not qualify if…
- BMI >= 40 kg/m2
- Significant cardiovascular disease
- HbA1c >= 10%
- Uncontrolled hypertension
- Active muscle disease
- estimated glomerular filtration rate < 60 mL/min
- Hepatic dysfunction
- History of participation in any clinical trial evaluating obicetrapib
- Anemia
- History of malignancy
- Alcohol abuse
- Treatment with investigational product
- Treatment with PCSK9
- Clinically significant condition
- Known CETP inhibitor allergy
Where it is running
- Velocity Clinical Research - Westlake d.b.a National Research Institute — Los Angeles, California, United States
- Valley Clinical Trials, Inc. — Northridge, California, United States
- Ocala Cardiovascular Research — Ocala, Florida, United States
- A & R Research Group, LLC — Pembroke Pines, Florida, United States
- Progressive Medical Research — Port Orange, Florida, United States
- Meridian Clinical Research - Savannah, GA — Savannah, Georgia, United States
- Velocity Clinical Research — Meridian, Idaho, United States
- Biofortis, Inc — Addison, Illinois, United States
- Northwest Heart Clinical Research, LLC — Arlington Heights, Illinois, United States
- Midwest Institute for Clinical Research — Indianapolis, Indiana, United States
- Research Integrity LLC — Owensboro, Kentucky, United States
- Oakland Medical Research Center — Troy, Michigan, United States
- Mercury Street Medical — Butte, Montana, United States
- Meridian Clinical Research- Springdale, OH — Cincinnati, Ohio, United States
- Aventiv Research, Inc. — Columbus, Ohio, United States
- Summit Research Group, LLC — Munroe Falls, Ohio, United States
Full record on ClinicalTrials.gov
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