Trial · Interventional

CompletedPhase 1Results postedRegistry data

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

NCTNCT05810597Other id18698Other idI8F-MC-GPIP

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Overview

Status: Completed
Phase: Phase 1
Enrollment: 65 participants (actual)
Sponsor: Eli Lilly and Company · Industry
Design: Randomized · Open label (no masking)
Countries: 1 country
United States
Start: 3 Apr 2023
Primary completion: 17 Jul 2023
Completion: 17 Jul 2023
First posted: 12 Apr 2023
Last update posted: 15 Oct 2024
Conditions: Healthy

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20232024

Ph 1
A Research Study Looking at Similarity Between Tirzepatide Versions for Different Injection Devices
NCT05810597
3 Apr 2023 to 17 Jul 2023

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

TirzepatideDrug
Single Dose PenDevice
Multi-use Prefilled PenDevice

Arms2

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.
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.

Primary outcomes3

Outcomes the sponsor listed as primary.

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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeGeometric mean· 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.

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

Group	Value (nanograms per milliliter (ng/mL))	Spread
Tirzepatide (SDP)	647	31
Tirzepatide (MUPFP)	524	27

Primary outcomeGeometric mean· 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

Group	Value (nanogram hour per milliliter (ngh/mL))	Spread
Tirzepatide (SDP)	124000	23
Tirzepatide (MUPFP)	118000	22

Primary outcomeGeometric mean· 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

Group	Value (ng*h/mL)	Spread
Tirzepatide (SDP)	126000	22
Tirzepatide (MUPFP)	119000	22

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Tirzepatide (SDP)Participants received 5 mg tirzepatide SC via an SDP.	0 / 65	0 / 65	38 / 65
Tirzepatide (MUPFP)Participants received 5 mg tirzepatide SC via a MUPFP.	0 / 62	0 / 62	28 / 62

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 70 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

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

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