A Study to Evaluate MK1903 in Patients With Dyslipidemia (MK1903-004)
Condition: Dyslipidemia
MeSH terms: Dyslipidemias
Intervention: MK1903; Comparator: Placebo
Intervention description: 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.; 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.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 191.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        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