A Study of Tirzepatide Administered by Two Different Devices in Healthy Participants

NCTNCT04004988Other id17105Other idI8F-MC-GPGS

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 1
Enrollment: 47 participants (actual)
Sponsor: Eli Lilly and Company · Industry
Design: Randomized · Open label (no masking)
Countries: 1 country
Singapore
Start: 19 Aug 2019
Primary completion: 16 Dec 2019
Completion: 16 Dec 2019
First posted: 2 Jul 2019
Last update posted: 18 Apr 2023
Conditions: Healthy

Timeline

1 trial · 1 completed · 1 with posted results

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

20192020

Ph 1
A Study of Tirzepatide Administered by Two Different Devices in Healthy Participants
NCT04004988
19 Aug 2019 to 16 Dec 2019

Registry summary

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

The purpose of this study is to compare the amount of tirzepatide that gets into the blood stream and how long it takes the body to get rid of it, when given as a solution formulation via an autoinjector versus a conventional prefilled syringe. The tolerability of tirzepatide will also be evaluated and information about any adverse effects experienced will be collected. Screening is required within 28 days prior to the start of the study. For each participant, the total duration of the clinical trial will be about 14 weeks, including screening.

Interventions

TirzepatideDrug
Prefilled syringe (PFS)Device
Auto-injector (AI)Device

Arms2

Experimental
Tirzepatide Test
Participants received single dose of 5 milligram (mg) Tirzepatide by subcutaneous injection (SC) via an autoinjector (AI) in one of two study periods.
Experimental
Tirzepatide Reference
Participants received single dose of 5mg Tirzepatide by subcutaneous injection (SC) via a prefilled syringe (PFS) in one of two study periods.

Primary outcomes2

Outcomes the sponsor listed as primary.

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide From Time Zero to Infinity (AUC0toinf)
Time frame · Predose, 8hours(h), 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 168h, 336h , 480h, 864h postdose
Registry description
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide from Time Zero to Infinity (AUC0toinf) was reported.
PK: Maximum Observed Plasma Concentration (Cmax) of Tirzepatide
Time frame · Predose, 8hours(h), 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 168h, 336h , 480h, 864h postdose
Registry description
PK: Maximum Observed Plasma Concentration (Cmax) of Tirzepatide was reported

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, 8hours(h), 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 168h, 336h , 480h, 864h postdose

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide From Time Zero to Infinity (AUC0toinf)

Group	Value (Nanogramhour per milliliter (ngh/mL))	Spread
5 mg Tirzepatide AI	101000	18
5 mg Tirzepatide PFS	104000	18

Primary outcomeGeometric mean· Predose, 8hours(h), 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 168h, 336h , 480h, 864h postdose

PK: Maximum Observed Plasma Concentration (Cmax) of Tirzepatide

Group	Value (Nanogram per Milliliter (ng/mL))	Spread
5 mg Tirzepatide AI	530	25
5 mg Tirzepatide PFS	556	22

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
5 mg Tirzepatide AIParticipants received single dose of 5 mg tirzepatide by SC injection administered through autoinjector.	0 / 42	0 / 42	40 / 42
5 mg Tirzepatide PFSParticipants received single dose of 5 mg tirzepatide by SC injection administered through prefilled syringe.	0 / 44	1 / 44	42 / 44

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 21 Years up to 70 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Healthy males or females of nonchildbearing potential as determined by medical history, physical examination, and other screening procedures * Are between the body mass index (BMI) of 18.0 and 32.0 kilograms per meter squared (kg/m²), inclusive, at screening * Are agreeable to receiving study treatment by injections under the skin Exclusion Criteria: * Have known allergies to tirzepatide or related compounds * Have a personal or family history of medullary thyroid carcinoma or have multiple endocrine neoplasia syndrome type 2 * Have a history or presence of pancreatitis (history of chronic pancreatitis or idiopathic acute pancreatitis), elevation in serum amylase or lipase or GI disorder (eg, relevant esophageal reflux or gall bladder disease) or any GI disease which impacts gastric emptying (eg, gastric bypass surgery, pyloric stenosis, with the exception of appendectomy) or could be aggravated by glucagon-like peptide-1 (GLP-1) analogs or dipeptidyl peptidase IV (DPP-IV) inhibitors * Have a prior history of malignant disease(s) in the past 5 years prior to screening * Smoke more than the equivalent of 10 cigarettes per day * Is a known user of drugs of abuse

PepBank is a research reference. Talk to a doctor before you use any peptide.