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

Phase 1

Completed

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.

Recruitment & 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 18.5 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

Arm && Interventions

Group	Intervention	Description
Tirzepatide - Upper Arm	Tirzepatide	Participants received 5mg Tirzepatide by subcutaneous injection on upper arm.
Tirzepatide - Thigh	Tirzepatide	Participants received 5mg Tirzepatide by subcutaneous injection on thigh.
Tirzepatide - Abdomen	Tirzepatide	Participants received 5mg Tirzepatide by subcutaneous injection on abdomen.

Primary Outcome Measures

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

Secondary Outcome Measures