A Study of Tirzepatide (LY3298176) in Healthy Participants
Condition: Healthy
Intervention: Tirzepatide; Tirzepatide; Placebo; Tirzepatide
Intervention description: Administered SC; Administered IV; Administered SC; Administered IV
Intervention MeSH terms: Tirzepatide
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking description: Part A, B and D are not blinded. Part C is blinded to Participant and Investigator
Enrollment: 52.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study has four parts. Each participant will enroll in one part.

      Part A: The purpose of Part A is to compare study drug tirzepatide solution formulation to a
      powder formulation mixed with water and given subcutaneously (SC) (just under the skin). Part
      A will measure how much of the study drug gets into the blood stream and how long it takes
      the body to get rid of it.

      Part B: The purpose of Part B is to evaluate the safety and tolerability of tirzepatide
      intravenous (IV) formulation when administered into a vein.

      Part C: The purpose of Part C is to evaluate the safety and tolerability of tirzepatide
      following multiple SC weekly doses of a solution.

      Part D: The purpose of Part D is to evaluate the safety and tolerability of tirzepatide
      following single IV bolus dose of lyophilized formulation.

      This study will last approximately 70 days for each part (Part A, Part B or Part D) and 92
      days for Part C. This does not include screening. Screening is required within 28 days prior
      to the start of the study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Overtly healthy males or females, as determined by medical history and physical
             examination

          -  Male participants: agree to use an effective method of contraception for the duration
             of the study and for 3 months following the last dose of investigational product

          -  Female participants: not of childbearing potential due to surgical sterilization
             (hysterectomy or bilateral oophorectomy or tubal ligation) or menopause. Women with an
             intact uterus are deemed postmenopausal if they are greater than or equal to (≥)45
             years old and have not taken hormones or oral contraceptives within the last year and
             had cessation of menses for at least 1 year. Or, have had at least 6 months of
             amenorrhea with follicle-stimulating hormone levels consistent with a postmenopausal
             state

          -  Have a body mass index of 18.5 to 32.0 kilograms per meter squared (kg/m²) inclusive

        Exclusion Criteria:

          -  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

          -  Received treatment with a drug that has not received regulatory approval for any
             indication within 30 days of screening

          -  Have a history of heart block, or a pulse rate (PR) interval greater than (>)200
             milliseconds (msec), or any abnormality in the 12-lead electrocardiogram (ECG) at
             screening that, in the opinion of the investigator, increases the risks associated
             with participating in the study

          -  Have a significant history of or current cardiovascular (myocardial infarction,
             congestive heart failure, cerebrovascular accident, venous thromboembolism, etc.),
             respiratory, hepatic, renal, gastrointestinal (GI), endocrine, hematological
             (including history of thrombocytopenia), or neurological disorders capable of
             significantly altering the absorption, metabolism, or elimination of drugs, or of
             constituting a risk when taking the study medication, or interfering with the
             interpretation of data