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A Single-Site, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Glucodynamic Effects of LY3192767 in Healthy Subjects (NCT03025009)

The main purpose of this study is to investigate the side effects related to LY3192767 when given as an injection under the skin to healthy participants. Blood tests will be done to check how much LY3192767 is absorbed into the bloodstream, how long it takes for the body to get rid of it, and how it affects blood sugar levels. The study has two parts: Part A and Part B. Each participant will enroll in one part. For each participant, Part A will last up to about 32 days after last dose and Part B will last up to about 49 days after last dose. Screening must be completed prior to study start.
  • Drug: LY3192767
    Administered SC.
    • Drug: Basal Insulin Peglispro
      Administered SC.
      • LY2605541
    • Drug: Insulin Glargine
      Administered SC.
      • Drug: Placebo
        Administered SC.
        Ages eligible for Study
        20 Years to 64 Years
        Genders eligible for Study
        All
        Accepts Healthy Volunteers
        Accepts Healthy Volunteers
        Inclusion Criteria:
        • Are overtly healthy males or females, as determined by medical history and physical examination
        • Have a body mass index (BMI) of >18.5 and <30.0 kilogram per square meter (kg/m²), inclusive
        Exclusion Criteria:
        • Are currently enrolled in a clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study
        • Have participated, within the last 30 days, in a clinical trial involving an investigational product. If the previous investigational product has a long half-life, 3 months or 5 half-lives (whichever is longer) should have passed
        • Have participated as a participant in a first-in-human study within 90 days of the initial dose of study drug
        • Have known allergies to insulin, heparin, or related drugs, or history of relevant allergic reactions of any origin
        • Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, chronic inflammatory disease, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data

        1 locations

        Germany (1)
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
          recruiting
          Neuss, Nordrhein-Westfalen, Germany, 41460
        Status:
        recruiting
        Type:
        Interventional
        Phase:
        Start:
        12 March, 2017
        Updated:
        19 March, 2017
        Participants:
        85
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