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

Healthy Clinical Trial

Official title:

A Study to Compare the Pharmacokinetics of Tirzepatide Administered Subcutaneously by an Autoinjector Versus Prefilled Syringe in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04004988
• Other study ID #: 17105
• Secondary ID: I8F-MC-GPGS
• Status: Completed
• Phase: Phase 1
• Start date: August 19, 2019
• Est. completion date: December 16, 2019

Study information

• Verified date: April 1, 2023
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: December 16, 2019
• Est. primary completion date: December 16, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Tirzepatide
Administered SC

Device:
• Prefilled syringe (PFS)
PFS used to administer tirzepatide
• Auto-injector (AI)
AI used to administer tirzepatide

Locations

Country	Name	City	State
Singapore	Lilly Nus Centre for Clin Pharmacology	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Singapore, 

Outcome

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