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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Tirzepatide; Device: Auto-injector (AI); Device: Prefilled syringe (PFS)

• Registration Number: NCT04004988
• Lead Sponsor: Eli Lilly and Company

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-06-28
• Study First Submitted QC: 2019-06-28
• Study First Posted: 2019-07-02
• Study Start: 2019-08-19
• Primary Completion: 2019-12-16
• Study Completion: 2019-12-16
• Results First Submitted: 2022-06-09
• Status Verified: 2023-04-01
• Results First Submitted QC: 2023-04-17
• Last Update Submitted: 2023-04-17
• Results First Posted: 2023-04-18
• Last Update Posted: 2023-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Tirzepatide Test	Auto-injector (AI)	Participants received single dose of 5 milligram (mg) Tirzepatide by subcutaneous injection (SC) via an autoinjector (AI) in one of two study periods.
Tirzepatide Reference	Prefilled syringe (PFS)	Participants received single dose of 5mg Tirzepatide by subcutaneous injection (SC) via a prefilled syringe (PFS) in one of two study periods.
Tirzepatide Test	Tirzepatide	Participants received single dose of 5 milligram (mg) Tirzepatide by subcutaneous injection (SC) via an autoinjector (AI) in one of two study periods.
Tirzepatide Reference	Tirzepatide	Participants received single dose of 5mg Tirzepatide by subcutaneous injection (SC) via a prefilled syringe (PFS) in one of two study periods.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Lilly Nus Centre for Clin Pharmacology; 🇸🇬 Singapore, Singapore