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MK0653, ezetimibe

Phase 3

Coronary Disease | Small molecule | Cardiovascular |Organon & Co.|Last Updated: Aug 15, 2024

Target and mechanism

ModalitySmall molecule

Also known as MK-0653, ezetimibe

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment616

FDA Designations

No designations recorded

Clinical trial landscape

MK0653, ezetimibe · 16 trials · 8 indications

Phase 3 16
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
NCT00328523TWICE (Ezetimibe Together With Any Statin Cholesterol Enhancement)(0653-060)Hypercholesterolaemia
COMPLETED1,496 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
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
TWICE (Ezetimibe Together With Any Statin Cholesterol Enhancement)(0653-060)
HypercholesterolaemiaUnlock 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

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
Percent of patients attaining the ldl cholesterol target goal based on the lipids result at the end of the study (3 months).
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 evaluate the effect on the reduction in low density lipoprotein cholesterol (LDL-C) after the initial 6-week treatment period.
LDL-C measurement (target goal = <100 mg/dL)
27 Weeks
Percent change in fasting LDL-C from baseline to the average of the Week 6/Week 12 measurements
6 & 12 Weeks
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.
Treatment with ezetimibe 10 mg/day will be well tolerated and no difference in tolerance will be shown between the 3 treatment groups.
Safety and tolerability.
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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 -
MK-0653, ezetimibeDRUG -
Duration of Treatment: 3 monthsDRUG -
Comparator: ezetimibe, placeboDRUG -
Comparator: fenofibrate monotherapyDRUG -
Comparator: statinsDRUG -
MK0653, ezetimibe / Duration of Treatment: 28 weeksDRUG -
Comparator: atorvastatin / Duration of Treatment: 28 weeksDRUG -
MK0653, ezetimibe / Duration of Treatment: 27 WeeksDRUG -
MK0733, simvastatin / Duration of Treatment: 27 WeeksDRUG -
Comparator: simvastatin / Duration of Treatment: 27 WeeksDRUG -
MK0653, ezetimibe / Duration of Treatment: 30 WeeksDRUG -
Comparator : ezetimibe (+) simvastatin / Duration of Treatment: 30 WeeksDRUG -
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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 MK0653, ezetimibe?

MK0653, ezetimibe is a small molecule drug developed by Organon & Co. (ticker OGN) that is in Phase 3 clinical development. It has been studied across cardiovascular and metabolic conditions, including coronary disease, type 2 diabetes mellitus, hypercholesterolemia, hypercholesterolaemia, and inborn errors of lipid metabolism.

What is MK0653, ezetimibe used for?

MK0653, ezetimibe has been studied for coronary disease, type 2 diabetes mellitus, hypercholesterolemia, hypercholesterolaemia, and inborn errors of lipid metabolism. Trials have evaluated it both as a single agent and in combination with simvastatin, including in patients at risk for heart disease and in patients with type 2 diabetes.

Who makes MK0653, ezetimibe?

MK0653, ezetimibe is developed by Organon & Co., which trades under the ticker OGN. Organon is the sponsor associated with the clinical trial program for this asset, which includes ten completed studies enrolling a total of 6,977 participants.

What phase is MK0653, ezetimibe in?

MK0653, ezetimibe is in Phase 3 development. All ten of its listed clinical trials are Phase 3 studies, and all ten are completed, with no active trials currently listed. The program has enrolled 6,977 participants in total.

What clinical trials is MK0653, ezetimibe in?

Completed Phase 3 trials include NCT00551876, which compared simvastatin alone with simvastatin plus ezetimibe in type 2 diabetic patients, and NCT00551447, which compared ezetimibe plus simvastatin with simvastatin alone in patients at risk for heart disease. Other studies include NCT00457275 and NCT00395473 in hypercholesterolemia.

Is MK0653 the same as ezetimibe?

Yes, MK0653 and ezetimibe refer to the same drug. MK0653 is the compound designation used in the trial registry entries, while ezetimibe is the drug name. Registry listings also append duration-of-treatment labels such as 4 weeks, 6 weeks, 27 weeks, 28 weeks, and 30 weeks to distinguish individual studies.