drugset / Trial / NCT02759107

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

NCT02759107

Phase 1 Completed 142 enrolled Eli Lilly and Company
RandomizedParallel-groupDouble-blindBasic science

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.

Timeline

Start
2016-05-11
Primary completion
2017-06-26
Completion
2017-06-26

Drugs

EvaluationDrugModalityDoseRoute
Comparator Dulaglutide Peptide 1.5 mg Subcutaneous
Subject Tirzepatide Peptide 0.25 mg Subcutaneous
Subject Tirzepatide Peptide 0.5 mg Subcutaneous
Subject Tirzepatide Peptide 1 mg Subcutaneous
Subject Tirzepatide Peptide 1.5 mg Subcutaneous
Subject Tirzepatide Peptide 2.5 mg Subcutaneous
Subject Tirzepatide Peptide 4.5 mg Subcutaneous
Subject Tirzepatide Peptide 5 mg Subcutaneous
Subject Tirzepatide Peptide 8 mg Subcutaneous
Subject Tirzepatide Peptide 10 mg Subcutaneous
Subject Tirzepatide Peptide 15 mg Subcutaneous