Last updated on November 2016

A 12-Week Phase 2 Study of Gemcabene in Hypercholesterolemia Patients on Stable Moderate and High-Intensity Statins

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Hypercholesteremia
  • Age: Between 18 - 100 Years
  • Gender: Male or Female
  • Other:
    Provision of written and signed informed consent (by subject or legal guardian) prior
    to any study-specific procedures;
    Male or female (neither pregnant or lactating) ≥ 18 years of age at the time of
    Currently on a stable, low-fat, low-cholesterol diet in combination with allowed
    tatin doses as described in Table 1, with or without ezetemibe 10 mg QD for at least
    12 weeks prior to the Screening Visit;
    Fasting LDL-C value ≥ 100 mg/dL (2.59 mmol/L) at the Screening Visit;
    Physical examination, including vital signs, that is within normal limits or
    clinically acceptable to the Investigator;
    Weight ≥ 50 kg; with a body mass index (BMI) ≤ 45 kg/m2
    Subjects with Type 2 diabetes who take anti-hyperglycemic agents must be on a stable
    regimen for at least 3 months, with no planned changes in medications for the study

You may not be eligible for this study if the following are true:

  • Abnormal liver function test at the Pre-Screening or Screening Visit (AST or ALT) >
    2x ULN (upper limit of normal), total bilirubin > 1.5x ULN, or alkaline phosphate >
    2x ULN based on appropriate age and gender normal values. Subjects with bilirubin >
    5x ULN and a history of Gilbert's syndrome may be included; relfexive direct
    bilirubin testing will be used to confirm Gilbert's syndrome;
    Moderate (Grade B) or severe (Grade C) chronic hepatic impairment according to the
    Child-Pugh classification;
    Active liver disease (e.g. cirrhosis, alcoholic liver disease, hepatitis B, hepatitis
    C, automimmune hepatitis, liver failure, liver cancer), history of liver transplant,
    known diagnosis of HIV or AIDS;
    Triglyceride value ≥ 500 mg/dL at the Pre-Screening Visit or the Screening Visit;
    Moderate to severe renal insufficiency define as an estimated GFR < 60mL/min/1.73m
    (calculated using the Chronic Kidney Disease Epidemiology Collaboration equation) at
    the Pre-Screening Visit or Screening Visit;
    Abnormal urinalysis (proteinuria greater than trace or any male or non-menstruating
    female with greater than trace hematuria) confirmed by reflexive urine
    protein:creatinine ration testing;
    Uncontrolled thyroid disease; hyperthyroidism or hypothyroidism as defined by thyroid
    timulating hormone (TSH) below the lower limit of normal or > 1.5x ULN,
    respectively, based on results from the Pre-Screening Visit or the Screening Visit.
    If controlled, treatment should be stable for at least 3 months prior to Screening;
    Type 1 diabetes mellitus or uncontrolled type 2 diabetes mellitus (hemoglobin A1c
    value > 8.5% based on results from the Pre-Screening or Screening Visit, or taking a
    thiazolidinedione (i.e. pioglitazone or rosiglitazone);
    New York Heart Association Class III or IV heart failure;
    Myocardial infarction, severe or unstable angina pectoris, coronary angioplasty,
    coronary artery bypass graft, or other major cardiovascular events resulting in
    hospitalization within 3 months of the Screening Visit. Subjects with adequately
    treated stable angina, per Investigator assessment, may be included;
    Uncontrolled cardiac arrhythmia or prolonged QT on the Screening Visit or Day 1 prior
    to dosing ECG (QTcF > 450 msec for men and > 470 msec for women) or known family
    history of prolonged QT or unexplained sudden cardiac death;
    Uncontrolled hypertension, defined as sitting systolic blood pressure > 180 mmHg or
    diastolic blood pressure > 110 mmHg, and confirmed by repeat measurement;
    Currently receiving cancer treatments or, in the Investigator's opinion, at risk of
    relapse for recent cancer;
    Inadequate wash-out of a PCSK9 inhibitor (8 weeks prior to the Screening Visit), a
    fibrate lipid-regulating agent (6 weeks prior to the Screening Visit), niacins (4
    weeks prior to the Screening Visit), or other lipid-regulating therapies such as bile
    acid sequestrants (4 weeks prior to the Screening Visit);
    Hypersensitivity to or a history of significant adverse reactions to any fibrate
    lipid-regulating agent;
    Use of any excluded medications or supplements (e.g. potent cytochrome P450 [CYP] 3A4
    inhibitors as described in Appendix D;
    History of drug or alcohol abuse within the past year or inabilty to comply with
    protocol requirements, including subjects restrictions (see Section 5.6.3);
    Previously treated with gemcabene (CI-1027), participation in another clinical study
    of an investigational agent or device concurrently or within 1 month prior the
    Screening Visit, or use of an investigational agent within 1 month or 5 half-lives
    (if known), whichever is longer, prior to the Screening Visit;
    Any other finding which, in the opinion of the Investigator, would compromise the
    ubject's safety or participation in the study.

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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