A Study to Evaluate MK1903 in Patients With Dyslipidemia (MK1903-004)

Study Overview
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Brief Summary
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This study will evaluate the lipid-modifying effect and tolerability of MK1903 when compared to placebo in patients with dyslipidemia who are not on a statin or other lipid-modifying therapy.

Official Title
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A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Lipid-Modifying Effect and Tolerability of MK1903 in Patients With Dyslipidemia

Conditions
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Dyslipidemia

Intervention / Treatment
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* Drug: MK1903
* Drug: Comparator: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant is not on a statin or other lipid-modifying therapy Low or moderate risk participant Male participants, and female participants not of reproductive potential Exclusion Criteria: Female participant of reproductive potential Participant is pregnant, breastfeeding, or expecting to conceive during the study Participant has history of cancer within 5 years of study (except certain types of skin and cervical cancer) Participant is a user of recreational or illicit drugs or has a recent history of drug and/or alcohol abuse Participant has donated or received blood within 8 weeks of study start or intends to give/receive blood during the study Participant consumes more than 3 alcoholic drinks per day or more than 14 alcoholic drinks per week Participant is currently experiencing menopausal hot flashes Participant currently engages in vigorous exercise or an aggressive diet regimen Participant is at high risk for heart conditions Participant has Type 1 or Type 2 diabetes mellitus Participant has poorly controlled cardiac arrhythmias Participant has a history of stroke or other hemorrhage Participant has poorly controlled high blood pressure Participant has a thyroid condition or other endocrine/metabolic disease that would affect serum lipids Participant has a disease of the kidney or liver Participant has an ulcer within 3 months of screening Participant is Human Immunodeficiency Virus (HIV) positive Participant is taking cyclical hormonal contraceptives or non-continuous hormone replacement therapy Participant is taking or has taken an Organic Anion Transporter (OAT1/3) inhibitor/substrate within 3 days of screening Participant has taken an anti-obesity medication within 3 months of screening Participant is taking coumarins Participant is taking Non-steroidal Anti-inflammatory Drugs (NSAIDs) (acetaminophen and Cyclooxygenase-2 (COX-2) inhibitors are allowed) Participant is taking more than 100 mg aspirin per day Participant is being treated with oral, intravenous, or injected corticosteroids or anabolic agents

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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>MK1903 | Drug: MK1903<br>* Three 50 mg capsules MK1903 by mouth every 8 hours for 4 weeks. All participants will receive placebo for a 2 week run-in period.<br>|
| Placebo Comparator: 2<br>Placebo to MK1903 | Drug: Comparator: Placebo<br>* Three 50 mg capsules placebo to MK1903 every 8 hours for 4 weeks. All participants will receive placebo for a 2 week run-in period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) (mg/dL) |  | Baseline and Week 4 | 
| Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) (mg/dL) |  | Baseline and Week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change From Baseline in Triglycerides (mg/dL) |  | Baseline and 4 Weeks |