A Study of LY2605541 in Healthy Participants and in the Elderly
Condition: Healthy Volunteers
Intervention: LY2605541
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 52.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will include 2 groups (cohorts) of participants:

      In Cohort A, this study will look at the amount of LY2605541 that is present in the body
      after it is injected in 3 different locations in the body of the same participant. At least
      16 days will pass between each injection.

      In Cohort B, the study will look at how the body absorbs, distributes, and disposes of
      LY2605541 in participants aged 65 and over.

      Participants may enroll in only one cohort.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Cohort A: are overtly healthy male or female participants, as determined by medical
             history and physical examination, aged ≥18 to ≤55 years of age

          -  Cohort B: are male or female elderly (≥65 years of age) participants that are overtly
             healthy, or have stable, chronic medical conditions (including Type 2 Diabetes
             Mellitus [T2DM]) that, in the investigator's opinion, will not significantly alter the
             disposition of the drug, will not place the participant at increased risk by
             participating in the study, and will not interfere with interpretation of the data

          -  Male participants agree to use a reliable method of birth control during the study and
             for 3 months following the last dose of the investigational product

          -  Female participants are women of child-bearing potential who test negative for
             pregnancy at the time of screening based on a urine pregnancy test and agree to use a
             reliable method of birth control during the study and for 1 month following the last
             dose of the investigational product

          -  Female participants are post-menopausal women, or women not of child-bearing potential
             due to surgical sterilization (at least 3 months after surgical hysterectomy, or at
             least 3 months after bilateral oophorectomy or bilateral tubal ligation/occlusion with
             or without hysterectomy) confirmed by medical history, or menopause

          -  Have a body mass index (BMI) of 18.5 to 40 kilogram per meter square (kg/m^2),
             inclusive, at time of admission for Period 1

          -  Have given written informed consent approved by Lilly and the ethical review board
             (ERB) governing the site

        Exclusion Criteria:

          -  Are participants that intend to start a change in diet or lose weight during the
             study; participants will be expected to maintain their approximate current weight
             throughout the study

          -  Are excessive smokers (>10 cigarettes per day); participants who smoke ≤10 cigarettes
             per day must be able to stop smoking while residing at the clinical research unit
             (CRU)

        Healthy Participants - Cohort A

          -  Have Type 1 Diabetes Mellitus (T1DM), Type 2 Diabetes Mellitus (T2DM), or a fasting
             blood glucose (BG) >110 milligrams per deciliter (mg/dL) (6.1 millimoles per liter
             [mmol/L]) with a glycated hemoglobin (HbA1c) of >6.2%

          -  Intend to use over-the-counter medication within the 7 days or prescription medication
             within 14 days prior to dosing (apart from contraceptive medication, vitamin/mineral
             supplements, occasional paracetamol, thyroxine replacement therapy, and hormone
             replacement therapy). Antihypertensive and lipid lowering agents are permitted, but
             must have been administered at stable dose(s) for at least 1 month.

        Elderly Participants - Cohort B

          -  Have T1DM

          -  Are T2DM participants that require insulin treatment, or have a HbA1c of >10%

          -  Have started new chronic medication(s) or changed the dose of an existing chronic
             medication <1 month prior to dosing. Participants are permitted to continue ongoing
             chronic medications (for example antihypertensive agents, aspirin, non-steroidal
             anti-inflammatory drugs, lipid lowering agents, thyroxine, hormone replacement
             therapy, and/or oral anti-diabetic if participants have T2DM). Other stable chronic
             conditions may be permitted if deemed acceptable by the investigators and Lilly
             clinical pharmacologist or clinical research physician.