A First-in-Human Study of LY3009385 in Healthy Participants
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Intervention: LY3009385; Placebo
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 40.0
Sex: All
Minimum age: 21 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The main purpose of this study is to determine the safety of LY3009385 in healthy
      participants. The study drug is given as a single dose, by injections under the skin. Side
      effects will be documented. This study is approximately 28 days not including screening.
      Screening is required within 28 days prior to the start of the study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are a healthy male or a female who cannot become pregnant

          -  Have a body mass index (BMI) of 18.5 to 32.0 kilograms per meter squared (kg/m^2) at
             screening

          -  Have blood pressure, pulse rate, as well as blood and urine laboratory test results
             acceptable for the study

          -  Have veins suitable for easy blood collection

          -  Are reliable and willing to be available for the whole study and be willing to follow
             study procedures

          -  Have given consent to participate in this study

        Exclusion Criteria:

          -  Are currently participating in or were in another new drug or device or in any medical
             research study in the last 30 days

          -  Currently have or used to have allergies or other health problems or laboratory test
             results that in the opinion of the doctor, could make it unsafe for the participant to
             participate, or interfere with understanding the results of this study

          -  Have received live vaccine(s) within 1 month of screening, or intend to during the
             study

          -  Have received treatment with biologic agents (such as monoclonal antibodies) within 3
             months or 5 half-lives (whichever is longer) prior to dosing

          -  Have a weakened immune system

          -  Have previously completed or withdrawn from this study

          -  Have illnesses or conditions that may increase risk when taking the study medication
             or interfere with the interpretation of data in this study

          -  Have electrocardiogram (ECG) readings that are not suitable for the study

          -  Are using or intend to use over-the-counter medications or prescription medications
             within 7 and 14 days (respectively) from the start of the first study dosing until end
             of the study

          -  Have a history of drug or alcohol abuse

          -  Are infected with hepatitis B

          -  Are infected with human immunodeficiency virus (HIV)

          -  Have donated 450 milliliters (mL) or more of blood in the last 3 months or made any
             blood donation within the last month

          -  Have a regular alcohol intake greater than 21 units per week (males) and 14 units per
             week (females) or are unwilling to abstain from alcohol 24 hours before dosing until
             the completion of each inpatient study period

          -  Smoke more than 10 cigarettes per day or are unable or unwilling to refrain from
             smoking while at the clinic

          -  Are unwilling or unable to follow dietary requirements/restrictions for the study and
             only consume only the meals provided during inpatient stays at the clinical research
             unit

          -  Are deemed unsuitable to participate by the study doctor for any other reasons