CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 52 enrolled
Drug / intervention
Tirzepatide +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03375463
NCT03375463Phase 1Completed

Pharmacokinetics, Safety, and Tolerability of a Solution Formulation of LY3298176 in Healthy Subjects

Eli Lilly and Company·interventional·Posted Dec 18, 2017·Updated Feb 5, 2024

In Brief

A Phase 1 clinical trial evaluating Tirzepatide and Placebo for Healthy. Completed, enrolled 52 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedDec 18, 2017
Enrollment StartDec 19, 2017
Primary CompletionDec 27, 2018
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 8.5 years ago

Interventions

Tirzepatidedrug

Administered SC

Tirzepatidedrug

Administered IV

Placebodrug

Administered SC

Tirzepatidedrug

Administered IV