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

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Device: Single Dose Pen; Drug: Tirzepatide; Device: Multi-use Prefilled Pen

Study type: Interventional

Funder types: Industry

Identifiers

NCT05810597

18698

I8F-MC-GPIP (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 65 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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65 participants in 2 patient groups

Sequence 1: Tirzepatide by Single Dose Pen (SDP)/ Multi-use Prefilled Pen (MUPFP)

Experimental group

Description:

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.

Treatment:

Device: Multi-use Prefilled Pen

Drug: Tirzepatide

Device: Single Dose Pen

Sequence 2: Tirzepatide by MUPFP / SDP

Experimental group

Description:

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.

Treatment:

Device: Multi-use Prefilled Pen

Drug: Tirzepatide

Device: Single Dose Pen