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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Tirzepatide; Device: Single Dose Pen; Device: Multi-use Prefilled Pen

• Registration Number: NCT05810597
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-31
• Study First Submitted QC: 2023-03-31
• Study Start: 2023-04-03
• Study First Posted: 2023-04-12
• Primary Completion: 2023-07-17
• Study Completion: 2023-07-17
• Status Verified: 2024-07-01
• Results First Submitted: 2024-07-17
• Results First Submitted QC: 2024-07-17
• Last Update Submitted: 2024-07-17
• Results First Posted: 2024-10-11
• Last Update Posted: 2024-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence 1: Tirzepatide by Single Dose Pen (SDP)/ Multi-use Prefilled Pen (MUPFP)	Tirzepatide	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.
Sequence 1: Tirzepatide by Single Dose Pen (SDP)/ Multi-use Prefilled Pen (MUPFP)	Single Dose Pen	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.
Sequence 1: Tirzepatide by Single Dose Pen (SDP)/ Multi-use Prefilled Pen (MUPFP)	Multi-use Prefilled Pen	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.
Sequence 2: Tirzepatide by MUPFP / SDP	Tirzepatide	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.
Sequence 2: Tirzepatide by MUPFP / SDP	Single Dose Pen	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.
Sequence 2: Tirzepatide by MUPFP / SDP	Multi-use Prefilled Pen	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.

Primary Outcome Measures

Name	Time	Method
PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (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.	PK: AUC(0-∞) of Tirzepatide
Pharmacokinetics (PK): Maximum Concentration (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: Cmax of Tirzepatide
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	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: AUC(0-t) of Tirzepatide

Trial Locations

Locations (3)

ICON; 🇺🇸 Salt Lake City, Utah, United States

Qps-Mra, Llc; 🇺🇸 South Miami, Florida, United States

ICON Early Phase Services; 🇺🇸 San Antonio, Texas, United States