Study of Obicetrapib & Ezetimibe Fixed Dose Combination on Top of Maximum Tolerated Lipid-Modifying Therapies
NCT ID: NCT06005597
Last Updated: 2025-10-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
407 participants
INTERVENTIONAL
2024-03-01
2024-10-16
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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Combination Therapy
once-daily obicetrapib 10 mg and ezetimibe 10 mg fixed dose combination tablet, placebo tablet, placebo capsule
Combination Therapy
tablet; 10mg obicetrapib and 10mg ezetimibe fixed does combination
Obicetrapib Placebo
tablet; no active ingredient
Ezetimibe Placebo
capsule; no active ingredient
Monotherapy obicetrapib
once-daily obicetrapib 10 mg, placebo tablet, placebo capsule
Monotherapy obicetrapib
tablet; 10mg obicetrapib
Combination Therapy placebo
tablet; no active ingredient
Ezetimibe Placebo
capsule; no active ingredient
Monotherapy ezetimibe
once-daily ezetimibe 10 mg capsule, 2 placebo tablets
Monotherapy ezetimibe
capsule; 10mg ezetimibe
Combination Therapy placebo
tablet; no active ingredient
Obicetrapib Placebo
tablet; no active ingredient
Placebo
once-daily placebo tablets (2), placebo capsule
Combination Therapy placebo
tablet; no active ingredient
Obicetrapib Placebo
tablet; no active ingredient
Ezetimibe Placebo
capsule; no active ingredient
Interventions
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Combination Therapy
tablet; 10mg obicetrapib and 10mg ezetimibe fixed does combination
Monotherapy obicetrapib
tablet; 10mg obicetrapib
Monotherapy ezetimibe
capsule; 10mg ezetimibe
Combination Therapy placebo
tablet; no active ingredient
Obicetrapib Placebo
tablet; no active ingredient
Ezetimibe Placebo
capsule; no active ingredient
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
ALL
No
Sponsors
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NewAmsterdam Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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Marc Ditmarsch, MD
Role: STUDY_DIRECTOR
NewAmsterdam Pharma
Locations
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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
Lucas Research, Inc
Morehead City, North Carolina, United States
Wilmington Health Associates
Wilmington, North Carolina, United States
Metabolic and Atherosclerosis Research Center
Cincinnati, Ohio, United States
Summit Research Group, LLC
Stow, Ohio, United States
Capital Area Research
Camp Hill, Pennsylvania, United States
Monument Health Clinical Research, a department of Monument Health Rapid City Hospital, Inc
Rapid City, South Dakota, United States
Chattanooga Research & Medicine, PLLC
Chattanooga, Tennessee, United States
Cardiovascular Research of Knoxville
Powell, Tennessee, United States
PharmaTex Research, LLC
Amarillo, Texas, United States
Amarillo Heart Clinical Research Institute, Inc
Amarillo, Texas, United States
South Texas Clinical Research
Corpus Christi, Texas, United States
Diabetes and Thyroid Center of Fort Worth
Fort Worth, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Juno Research, LLC - Medical Center Office
Houston, Texas, United States
DM Clinical Research
Houston, Texas, United States
Wellness Clinical Research Associates
McKinney, Texas, United States
Northwest Houston Heart Center
Tomball, Texas, United States
Alpine Research Organization, Inc.
Clinton, Utah, United States
Spectrum Medical, Inc.
Danville, Virginia, United States
Hampton Roads Center for Clinical Research
Suffolk, Virginia, United States
Countries
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References
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Sarraju A, Brennan D, Hayden K, Stronczek A, Goldberg AC, Michos ED, McGuire DK, Mason D, Tercek G, Nicholls SJ, Kling D, Neild AL, Kastelein J, Davidson M, Ditmarsch M, Nissen SE. Fixed-dose combination of obicetrapib and ezetimibe for LDL cholesterol reduction (TANDEM): a phase 3, randomised, double-blind, placebo-controlled trial. Lancet. 2025 May 17;405(10491):1757-1768. doi: 10.1016/S0140-6736(25)00721-4. Epub 2025 May 7.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Study results paper
Other Identifiers
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OBEZ-301
Identifier Type: -
Identifier Source: org_study_id
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