MK0767 in Metabolic Syndrome-Dyslipidemia (0767-016)

Study Overview
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Brief Summary
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This is a clinical trial in patients with Metabolic Syndrome and Dyslipidemia to study the effects of MK0767 on triglycerides.

Official Title
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A Multicenter, Double-Blind, Randomized, Placebo and Active-Controlled, Parallel Study to Evaluate the Lipid Altering Efficacy and Safety of MK0767 in Patients With Metabolic Syndrome and Dyslipidemia

Conditions
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Metabolic X Syndrome Dyslipidemia

Intervention / Treatment
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* Drug: MK0767
* Drug: Comparator: fenofibrate
* Drug: Comparator: Placebo (unspecified)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with Metabolic Syndrome and Dyslipidemia age 21 to 65 Patients will be eligible for the study if their triglyceride levels are within protocol specified range and have at least 2 of the criteria for Metabolic Syndrome as defined by NCEP Exclusion Criteria: Patients with a history of diabetes mellitus, partial ileal bypass, intolerant to fibric acid derivatives, requiring continuous oral corticosteroids, taking anti-seizure medications, documented coronary heart disease, renal insufficiency, proteinuria, viral hepatitis, cholelithiasis or other gallbladder disease, pancreatitis, neoplastic disease Patient is on cyclical estrogen medications Patient has taken lipid-lowering agents including fibric acid derivatives, bile acid sequestrants, HMG CoA reductase inhibitors and nicotinic acid derivatives within 8 weeks or probucol within 1 year of prior to visit 2

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>MK0767; 2.5 mg/day | Drug: MK0767<br>* MK0767 2.5, 5, and 10 mg/day supplied as tablets<br>|
| Experimental: 2<br>MK0767; 5mg/day | Drug: MK0767<br>* MK0767 2.5, 5, and 10 mg/day supplied as tablets<br>|
| Experimental: 3<br>MK0767; 10 mg/day | Drug: MK0767<br>* MK0767 2.5, 5, and 10 mg/day supplied as tablets<br>|
| Active Comparator: 4<br>fenofibrate 200 mg | Drug: Comparator: fenofibrate<br>* fenofibrate 200 mg supplied as capsules<br>|
| Placebo Comparator: 5<br>Matching Placebo | Drug: Comparator: Placebo (unspecified)<br>* matching placebo will be supplied as tablets/capsules.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| a dose-response will be seen across the doses of MK0767 and placebo in lowering fasting triglyceride. |  | After 12 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MK0767 will be safe and well tolerated |  | throughout study and at 12 weeks |