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MK0653, ezetimibe

Phase 3

Hypercholesterolemia | Small molecule | Metabolic |Organon & Co.|Last Updated: Aug 15, 2024

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials9
Total Enrollment6,322

FDA Designations

No designations recorded

Clinical trial landscape

MK0653, ezetimibe · 12 trials · 5 indications

Phase 3 12
NCT00457275Observational Study to Evaluate LDL-C Lowering Effect of Ezetimibe (0653-070)Hypercholesterolemia
COMPLETED440 Analytics
NCT00395473Ezetimibe Added to Statin Therapy (EASY) Study (0653-087)(COMPLETED)Hypercholesterolemia
COMPLETED141 Analytics
NCT00092898An Investigational Drug Study to Lower Non-Cholesterol Sterol Levels Associated With Sitosterolemia (0653-062)(COMPLETED)Lipid Metabolism, Inborn Errors
COMPLETED30 Analytics
NCT00092612Co-administration Study in Patients With Elevated Cholesterol and Coronary Heart Disease (0653-802)(COMPLETED)Hypercholesterolemia
COMPLETED372 Analytics
NCT00092638An Investigational Drug Study in Patients With Elevated Cholesterol and Coronary Heart Disease (0653-804)(COMPLETED)Hypercholesterolemia
COMPLETED450 Analytics
NCT00092573Study of Ezetimibe and Fenofibrate in Patients With Mixed Hyperlipidemia (0653-036)(COMPLETED)Hypercholesterolemia
COMPLETED576 Analytics
NCT00092625Co-administration Study in Patients With Elevated Cholesterol and Coronary Heart Disease (0653-803)Hypercholesterolemia
COMPLETED442 Analytics
NCT00092599Investigational Drug Study in Patients With Elevated Cholesterol and Coronary Heart Disease (0653-801)Hypercholesterolemia
COMPLETED410 Analytics
NCT00092560Two Investigational Drugs in Patients With Mixed Hyperlipidemia (0653-036)Hypercholesterolemia
COMPLETED587 Analytics
NCT00092586Study of an Approved Drug With a Statin (a Medication That Lowers Cholesterol Levels) as Compared to Statin Therapy Alone in Patients With High Cholesterol (0653-040)Hypercholesterolemia
COMPLETED2,904 Analytics
PHASE3COMPLETED
Observational Study to Evaluate LDL-C Lowering Effect of Ezetimibe (0653-070)
HypercholesterolemiaUnlock trial analytics
PHASE3COMPLETED
Ezetimibe Added to Statin Therapy (EASY) Study (0653-087)(COMPLETED)
HypercholesterolemiaUnlock trial analytics
PHASE3COMPLETED
An Investigational Drug Study to Lower Non-Cholesterol Sterol Levels Associated With Sitosterolemia (0653-062)(COMPLETED)
Lipid Metabolism, Inborn ErrorsUnlock trial analytics
PHASE3COMPLETED
Co-administration Study in Patients With Elevated Cholesterol and Coronary Heart Disease (0653-802)(COMPLETED)
HypercholesterolemiaUnlock trial analytics
PHASE3COMPLETED
An Investigational Drug Study in Patients With Elevated Cholesterol and Coronary Heart Disease (0653-804)(COMPLETED)
HypercholesterolemiaUnlock trial analytics
PHASE3COMPLETED
Study of Ezetimibe and Fenofibrate in Patients With Mixed Hyperlipidemia (0653-036)(COMPLETED)
HypercholesterolemiaUnlock trial analytics
PHASE3COMPLETED
Co-administration Study in Patients With Elevated Cholesterol and Coronary Heart Disease (0653-803)
HypercholesterolemiaUnlock trial analytics
PHASE3COMPLETED
Investigational Drug Study in Patients With Elevated Cholesterol and Coronary Heart Disease (0653-801)
HypercholesterolemiaUnlock trial analytics
PHASE3COMPLETED
Two Investigational Drugs in Patients With Mixed Hyperlipidemia (0653-036)
HypercholesterolemiaUnlock trial analytics
PHASE3COMPLETED
Study of an Approved Drug With a Statin (a Medication That Lowers Cholesterol Levels) as Compared to Statin Therapy Alone in Patients With High Cholesterol (0653-040)
HypercholesterolemiaUnlock trial analytics

Study Endpoints

Primary Endpoints

Approval
Percent (%) reduction in plasma low-density lipoprotein cholesterol (ldl-c) concentration after 6 weeks of treatment
Sitosterol concentrations after 26 weeks.
After 26 weeks
Percentage of patients reaching their target LDL-C goal of </= 2.60 mmol/L, after 6 weeks of treatment
Percentage of patients reaching their target LDL-C goal of </= 2.60 mmol/L, after 6 weeks of treatment.
Tolerability
Percentage of patients reaching LDL goal of <2.60 mmol/L after 6 weeks of treatment
Plasma LDL-C vs. fenofibrate for 12 weeks.
Percent change in LDL-C
To assess the percent change relative to baseline in plasma sitosterol concentration after long-term treatment with MK0653 10 mg/day.
Plasma sitosterol levels after 52 weeks.

Secondary Endpoints

Campesterol concentrations; Achilles tendon thickness; safety and tolerability.
Safety and tolerability.
Plasma LDL-C, HDL-C and triglycerides after 12 weeks.
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Interventions

NameTypeDescription
MK0653, ezetimibe / Duration of Treatment: 4 WeeksDRUG -
MK0653, ezetimibe / Duration of Treatment: 6 WeeksDRUG -
MK0653, ezetimibeDRUG -
Comparator: placeboDRUG -
Comparator: ezetimibe, placeboDRUG -
Comparator: fenofibrate monotherapyDRUG -
Comparator: statinsDRUG -
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Eligibility Criteria

Age Range18 Years to 80 Years
SexALL
Healthy VolunteersYes

Inclusion Criteria: * Men or women \>18 and \<80 years of age * Patients receiving statin therapy for a minimum period of 6 weeks prior to visit 1 * Female patients receiving hormone therapy (including hormone replacement therapy, any estrogen antagonist/agonist, or oral contraceptives) if maintain...

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Frequently asked questions about MK0653, ezetimibe

What is MK-0653 used for?

MK-0653, also known as ezetimibe, is used for hypercholesterolemia, including conditions like mixed hyperlipidemia and elevated cholesterol with coronary heart disease. It is being developed for lipid metabolism disorders and is in Phase 3 clinical trials.

What does MK-0653 target?

MK-0653 targets cholesterol absorption in the intestine. It is a small molecule that inhibits the absorption of cholesterol from the diet, thereby lowering blood cholesterol levels. This mechanism is relevant for treating hypercholesterolemia and related lipid disorders.

Who makes MK-0653?

MK-0653 is being developed by Organon & Co., a pharmaceutical company listed on the New York Stock Exchange under the ticker symbol OGN. The company is conducting Phase 3 clinical trials for this drug.

What phase is MK-0653 in?

MK-0653 is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. All nine clinical trials for MK-0653 have been completed, with no active trials currently ongoing.

What clinical trials is MK-0653 in?

MK-0653 has been studied in several Phase 3 clinical trials, including NCT00092560, NCT00092573, NCT00092599, and NCT00092612. These trials enrolled patients with hypercholesterolemia, hypertriglyceridemia, and coronary heart disease, with a total enrollment of over 6,000 participants.

Is MK-0653 the same as ezetimibe?

Yes, MK-0653 is also known as ezetimibe. This alternative name is used in clinical trial titles and medical literature. Ezetimibe is the generic name for this cholesterol-lowering medication.