A Study of Tirzepatide (LY3298176) in Healthy Participants and Participants With Type 2 Diabetes (T2DM)

Part of paid clinical trials in South Miami, Florida.

Sponsor
Eli Lilly and Company
Study ID
NCT02759107
Phase
PHASE1
Status
Completed

Conditions

  • Healthy
  • Type 2 Diabetes Mellitus (T2DM)

Eligibility Criteria

Sex
ALL
Age
21 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

Study Details

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.

Key Dates

Start date
May 11, 2016
Status verified
Apr 2023
Primary completion
Jun 26, 2017
Completion
Jun 26, 2017

Study Design

Enrollment
142 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Tirzepatide (Part A)
    Participants received escalating single doses of either 0.25 milligram (mg) or 0.5mg or 1mg, or 2.5mg or 5mg or 8mg Tirzepatide by subcutaneous injection.
  • Placebo Comparator: Placebo (Part A)
    Participants received single dose of placebo by subcutaneous injection.
  • Experimental: Tirzepatide (Part B)
    Participants received fixed doses of either 0.5mg or 1.5mg or 4.5mg Tirzepatide once weekly for four weeks or titrated doses of 5mg, 5mg, 8mg and 10mg Tirzepatide once weekly for four weeks by subcutaneous injection.
  • Placebo Comparator: Placebo (Part B)
    Participants received placebo once weekly for four weeks by subcutaneous injection.
  • Active Comparator: Dulaglutide (Part B)
    Participants received 1.5mg Dulaglutide once weekly for four weeks by subcutaneous injection.
  • Experimental: Tirzepatide (Part C)
    Participants received fixed doses of either 0.5mg or 5mg Tirzepatide once weekly for four weeks or titrated doses of 5mg,5mg,10mg,10mg or 5mg,5mg,10mg,15mg Tirzepatide once weekly for four weeks by subcutaneous injection
  • Placebo Comparator: Placebo (Part C)
    Participants received placebo once weekly for four weeks by subcutaneous injection.

Primary Outcome Measure

Number of Participants With One or More Serious Adverse Event(s) (SAEs) [ Time Frame: Baseline through Day 43 (Part A) and Day 57 (Part B and C) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Miami Research AssociatesSouth MiamiFlorida33143-

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By research site
Miami Research Associates· South Miami, FL

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