Randomized Study of Obicetrapib as an Adjunct to Statin Therapy
NCT ID: NCT04753606
Last Updated: 2024-07-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
120 participants
INTERVENTIONAL
2021-02-18
2021-08-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
once-daily placebo
Obicetrapib
tablets
obicetrapib 5 mg
once-daily obicetrapib
Obicetrapib
tablets
obicetrapib 10 mg
once-daily obicetrapib
Obicetrapib
tablets
Interventions
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Obicetrapib
tablets
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Treated with a high-intensity statin therapy
Exclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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NewAmsterdam Pharma
INDUSTRY
Responsible Party
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Locations
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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
Countries
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References
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Nicholls SJ, Ditmarsch M, Kastelein JJ, Rigby SP, Kling D, Curcio DL, Alp NJ, Davidson MH. Lipid lowering effects of the CETP inhibitor obicetrapib in combination with high-intensity statins: a randomized phase 2 trial. Nat Med. 2022 Aug;28(8):1672-1678. doi: 10.1038/s41591-022-01936-7. Epub 2022 Aug 11.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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TA-8995-201
Identifier Type: -
Identifier Source: org_study_id
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