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

Study Overview
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Brief Summary
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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.

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

Conditions
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Healthy

Intervention / Treatment
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* Drug: Tirzepatide
* Device: Prefilled syringe (PFS)
* Device: Auto-injector (AI)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tirzepatide Test<br>Participants received single dose of 5 milligram (mg) Tirzepatide by subcutaneous injection (SC) via an autoinjector (AI) in one of two study periods. | Drug: Tirzepatide<br>* Administered SC<br>* Other names: LY3298176;Device: Auto-injector (AI)<br>* AI used to administer tirzepatide<br>|
| Experimental: Tirzepatide Reference<br>Participants received single dose of 5mg Tirzepatide by subcutaneous injection (SC) via a prefilled syringe (PFS) in one of two study periods. | Drug: Tirzepatide<br>* Administered SC<br>* Other names: LY3298176;Device: Prefilled syringe (PFS)<br>* PFS used to administer tirzepatide<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 |