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

A Bioequivalence Study to Compare the Pharmacokinetics of Tirzepatide Administered Subcutaneously by a Test Device (Test Formulation) Versus Reference Device (Reference Formulation) in Healthy Participants

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 Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Tirzepatide; Device: Single Dose Pen; Device: Multi-use Prefilled Pen

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • South Miami, Florida, United States, 33143
      • Qps-Mra, Llc
  • Texas
    • San Antonio, Texas, United States, 78209
      • ICON Early Phase Services
  • Utah
    • Salt Lake City, Utah, United States, 84124
      • ICON

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence 1: Tirzepatide by Single Dose Pen (SDP)/ Multi-use Prefilled Pen (MUPFP); Participants received a single dose of 5 milligrams (mg) tirzepatide administered subcutaneously (SC) via an SDP in Period 1 followed by a single dose of 5 mg tirzepatide administered SC via a MUPFP in Period 2. There was a washout period of at least 35 days between tirzepatide dose administrations.	Drug: Tirzepatide; Administered SC; Other Names: LY3298176; Device: Single Dose Pen; Used to administer tirzepatide SC; Device: Multi-use Prefilled Pen; Used to administer tirzepatide SC
Experimental: Sequence 2: Tirzepatide by MUPFP / SDP; Participants received a single dose of 5 mg tirzepatide administered SC via a MUPFP in Period 1 followed by a single dose of 5 mg tirzepatide administered SC via an SDP in Period 2. There was a washout period of at least 35 days between tirzepatide dose administrations.	Drug: Tirzepatide; Administered SC; Other Names: LY3298176; Device: Single Dose Pen; Used to administer tirzepatide SC; Device: Multi-use Prefilled Pen; Used to administer tirzepatide SC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Tirzepatide	PK: Cmax of Tirzepatide	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	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	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.

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2023
• Primary Completion (Actual): July 17, 2023
• Study Completion (Actual): July 17, 2023

Study Registration Dates

• First Submitted: March 31, 2023
• First Submitted That Met QC Criteria: March 31, 2023
• First Posted (Actual): April 12, 2023

Study Record Updates

• Last Update Posted (Actual): October 15, 2024
• Last Update Submitted That Met QC Criteria: July 17, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Incretins; Tirzepatide
• Other Study ID Numbers: 18698; I8F-MC-GPIP (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes