A Research Study Looking at Similarity Between Tirzepatide Versions for Different Injection Devices

Eli Lilly and Company65 enrolled

Overview

The main purpose of this study is to look at the amount of the study drug, tirzepatide, that gets into the blood stream and how long it takes the body to get rid of it when given using two different devices. The study will also evaluate the safety and tolerability of tirzepatide and information about any side effects experienced will be collected. For each participant, the total duration of the study will be approximately 14 weeks, including screening.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

TirzepatideDRUG

Administered SC

Single Dose PenDEVICE

Used to administer tirzepatide SC

Multi-use Prefilled PenDEVICE

Used to administer tirzepatide SC

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy males or non-pregnant females as determined by medical history, physical examination, and other screening procedures * Body mass index (BMI) between 18.5 and 30.0 kilograms per meter squared (kg/m²), inclusive, at screening * Have blood pressure, pulse rate, blood and urine laboratory test results that are acceptable for the study * Are agreeable to receiving study treatment by injections under the skin * Are agreeable to following study contraception requirements Exclusion Criteria: * Have or used to have health problems that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study * Smoke more than the equivalent of 10 cigarettes per day * Is a known user of drugs of abuse

Locations (3)

Qps-Mra, Llc

South Miami, Florida, United States

ICON Early Phase Services

San Antonio, Texas, United States

ICON

Salt Lake City, Utah, United States

Outcomes

Primary Outcomes

Pharmacokinetics (PK): Maximum Concentration (Cmax) of Tirzepatide

PK: Cmax of Tirzepatide

Time frame: Predose, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 336, and 480 hours post Day 1 dose and on Day 36 of each study period.

PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Time t, Where t is the Last Time Point With a Measurable Concentration (AUC[0-t]) of Tirzepatide

PK: AUC(0-t) of Tirzepatide

Time frame: Predose, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 336, and 480 hours post Day 1 dose and on Day 36 of each study period.

PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Tirzepatide

PK: AUC(0-∞) of Tirzepatide

Time frame: Predose, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 336, and 480 hours post Day 1 dose and on Day 36 of each study period.

Data from ClinicalTrials.gov

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