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

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

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.

Study Overview

• Status: Completed
• Conditions: Dyslipidemia
• Intervention / Treatment: Drug: MK1903; Drug: Comparator: Placebo

• Study Type: Interventional
• Enrollment (Actual): 191
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; MK1903	Drug: MK1903; 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.
Placebo Comparator: 2; Placebo to MK1903	Drug: Comparator: Placebo; 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (Actual): September 1, 2009
• Study Completion (Actual): September 1, 2009

Study Registration Dates

• First Submitted: February 18, 2009
• First Submitted That Met QC Criteria: February 18, 2009
• First Posted (Estimate): February 19, 2009

Study Record Updates

• Last Update Posted (Estimate): December 21, 2015
• Last Update Submitted That Met QC Criteria: November 19, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias
• Other Study ID Numbers: 1903-004; 2009_542