NCT02759107

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

A Single- and Multiple-Ascending Dose Study in Healthy Subjects to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3298176 and Multiple Doses in Patients With Type 2 Diabetes Mellitus

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 142 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 21 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy
• Type 2 Diabetes Mellitus (T2DM)

Interventions

Type	Name	Description
DRUG	Tirzepatide	Administered SC
DRUG	Placebo	Administered SC
DRUG	Dulaglutide	Administered SC

Timeline

• Start date: 2016-05-11
• Primary completion: 2017-06-26
• Completion: 2017-06-26
• First posted: 2016-05-03
• Last updated: 2024-01-16
• Results posted: 2024-01-16

Locations

2 sites across 2 countries: United States, Singapore