A Study of Tirzepatide at Different Injection Sites in Participants With Different Body Sizes

Study Overview
=================
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 injected under the skin of the upper arm and thigh compared to the abdomen. The study will be conducted in healthy males and females with different body sizes. The tolerability of tirzepatide will be evaluated and information about any side effects experienced will be collected. For each participant, the study will last about 20 weeks, including screening.

Official Title
-----------------
Effect of Injection Site on the Relative Bioavailability of a Single Dose of Tirzepatide in Subjects With Low and High Body Mass Indices

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Tirzepatide


Participation Criteria
=================
Eligibility Criteria
-----------------
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 18.5 and 45.0 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 gastrointestinal (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
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

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 - Upper Arm<br>Participants received 5mg Tirzepatide by subcutaneous injection on upper arm. | Drug: Tirzepatide<br>* Tirzepatide administered SC<br>* Other names: LY3298176;|
| Experimental: Tirzepatide - Thigh<br>Participants received 5mg Tirzepatide by subcutaneous injection on thigh. | Drug: Tirzepatide<br>* Tirzepatide administered SC<br>* Other names: LY3298176;|
| Active Comparator: Tirzepatide - Abdomen<br>Participants received 5mg Tirzepatide by subcutaneous injection on abdomen. | Drug: Tirzepatide<br>* Tirzepatide administered SC<br>* Other names: LY3298176;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve of Tirzepatide From Time Zero to Infinity (AUC[0-∞]) | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve of Tirzepatide From Time Zero to Infinity (AUC[0-∞]) was evaluated. | Predose, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 336, 480 hours post dose | 
| PK: Maximum Concentration (Cmax) of Tirzepatide | PK: Maximum Concentration (Cmax) of Tirzepatide was evaluated. | Predose, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 336, 480 hours post dose |