GLPwatch

A Study of Tirzepatide (LY3298176) in Healthy Participants

NCT03375463 · Completed

Last updated 2026-05-28

This clinical trial tested how tirzepatide, a medication, is absorbed and processed in the body of healthy participants.

Status Completed The study has finished.
Phase Phase 1 Checks safety and dosing in a small group.
Type Interventional (clinical trial)
Design Randomized, double-blind basic-science study
Participants 52 people
Who can join Ages 18–70 · all sexes Healthy volunteers accepted.
Timeline Started 2017-12 · est. completion 2018-12
Where 1 site · United States

What this study is testing ClinicalTrials.gov NCT03375463 ↗

Description as written by the study sponsor.

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.

Treatments tested

Main thing measuredPharmacokinetics (PK) Part A: Area Under the Concentration Versus Time Curve [AUC (0-∞)] of Tirzepatide
SponsorEli Lilly and Company
Conditions studiedHealthy
GLP-1 drugs tirzepatide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT03375463 ↗