Randomized Study of Obicetrapib as an Adjunct to Statin 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 dose-finding study to evaluate the efficacy, safety, and tolerability of obicetrapib as an adjunct to high-intensity statin therapy.
Key facts
- Study ID
- NCT04753606
- Run by
- NewAmsterdam Pharma
- People needed
- 120
- Starts
- 2021-02-18
- Expected to finish
- 2021-08-30
- Last updated by the study team
- 2024-07-12
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 TG < 400 mg/dL,
- Treated with a high-intensity statin therapy
You may not qualify if…
- BMI > 40 kg/m
- Significant cardiovascular disease
- HbA1c > 10%
- Uncontrolled hypertension
- Active muscle disease
- GFR < 60 ml/min
- Hepatic dysfunction
- Anemia
- History of malignancy
- Alcohol abuse
- Treatment with investigational product
- Treatment with PCSK9
- Clinically significant condition
- Known CETP inhibitor allergy
Where it is running
- Pinnacle Research Group — Anniston, Alabama, United States
- National Research Institute - Huntington Park — Huntington Park, California, United States
- National Research Institute - Wilshire — Los Angeles, California, United States
- Clinical Trials Research — Sacramento, California, United States
- Jacksonville Center for Clinical Research — Jacksonville, Florida, United States
- Ocala Cardiovascular Research — Ocala, Florida, United States
- Progressive Medical Research — Port Orange, Florida, United States
- IACT Health — Columbus, Georgia, United States
- Evanston Premier Healthcare Research LLC — Evanston, Illinois, United States
- Midwest Institute for Clinical Research — Indianapolis, Indiana, United States
- Oakland Medical Research Center — Troy, Michigan, United States
- Diabetes and Endocrinology Consultants, P.C. — Morehead City, North Carolina, United States
- Lillestol Research, LLC — Fargo, North Dakota, United States
- Metabolic and Atherosclerosis Research Center — Cincinnati, Ohio, United States
- Summit Research Group, LLC — Munroe Falls, Ohio, United States
- Monument Health Clinical Research — Rapid City, South Dakota, United States
- Health Concepts — Rapid City, South Dakota, United States
- Juno Research, LL — Houston, Texas, United States
- Manassas Clinical Research Center — Manassas, Virginia, United States
Full record on ClinicalTrials.gov
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