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

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Tirzepatide

Study type: Interventional

Funder types: Industry

Identifiers

NCT04050670

I8F-MC-GPHI (Other Identifier)

17224

Details and patient eligibility

About

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.

Enrollment: 54 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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54 participants in 3 patient groups

Tirzepatide - Upper Arm

Experimental group

Description:

Participants received 5mg Tirzepatide by subcutaneous injection on upper arm.

Treatment:

Drug: Tirzepatide

Tirzepatide - Thigh

Experimental group

Description:

Participants received 5mg Tirzepatide by subcutaneous injection on thigh.

Treatment:

Drug: Tirzepatide

Tirzepatide - Abdomen

Active Comparator group

Description:

Participants received 5mg Tirzepatide by subcutaneous injection on abdomen.

Treatment:

Drug: Tirzepatide