A Study of Tirzepatide (LY3298176) in Healthy Participants and Participants With Type 2 Diabetes (T2DM)
Condition: Healthy; Type 2 Diabetes Mellitus (T2DM)
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Tirzepatide; Placebo; Dulaglutide
Intervention description: Administered SC; Administered SC; Administered SC
Intervention MeSH terms: Dulaglutide; Tirzepatide
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 142.0
Sex: All
Minimum age: 21 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The main purposes of this study are to determine:

        -  The safety of tirzepatide and any side effects that might be associated with it.

        -  How much tirzepatide gets into the bloodstream and how long it takes the body to get rid
           of it.

        -  How tirzepatide affects the levels of blood sugar.

      This study includes 3 parts (A, B and C). Part A involves a single dose of tirzepatide taken
      as a subcutaneous (SC) injection just under the skin and will be approximately 10 weeks in
      duration, including screening. Parts B and C involve 4 doses of tirzepatide taken once weekly
      (over 4 weeks) as a SC injection just under the skin and is approximately 12-14 weeks in
      duration, including screening. Each participant will enroll in only one part.

      This study is for research purposes only, and is not intended to treat any medical condition.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy participants (Parts A and B) and participants with T2DM diagnosed at least 1
             year before enrollment (Part C)

          -  Have a screening body mass index (BMI) of greater than 18.5 and less than or equal to
             40.0 kilograms per meter squared (kg/m²), inclusive

          -  Participants with T2DM (Part C only): have T2DM controlled with diet and exercise
             alone or are stable on a single oral antidiabetic medication (metformin for at least
             30 days or sulfonylureas). Participants receiving sulfonylureas may participate only
             if this treatment is stopped for at least 6 weeks before dosing with study drug

        Exclusion Criteria:

          -  Have known allergies to tirzepatide, glucagon-like peptide (GLP)-1 analogs, or related
             compounds

          -  Have an 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 history or presence of pancreatitis (history of chronic pancreatitis or
             idiopathic acute pancreatitis), elevation in serum amylase or lipase (greater than
             2-fold the upper limit of normal [ULN]) or gastrointestinal (GI) disorder (for
             example, relevant esophageal reflux or gall bladder disease) or any GI disease which
             impacts gastric emptying (for example, gastric bypass surgery, pyloric stenosis, with
             the exception of appendectomy) or could be aggravated by glucagon-like peptide-1
             (GLP-1) analogs or dipeptidyl peptidase (DPP)-IV inhibitors

        Participants with T2DM (Part C only)

          -  Have had more than 1 episode of severe hypoglycemia, as defined by the American
             Diabetes Association criteria, within 6 months before entry into the study or has a
             history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms

        All Study Participants (Parts B and C only)

          -  have known allergies to tirzepatide, GLP-1 analogs, or related compounds, or
             acetaminophen