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

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Device: Prefilled syringe (PFS); Device: Auto-injector (AI); Drug: Tirzepatide

Study type: Interventional

Funder types: Industry

Identifiers

NCT04004988

I8F-MC-GPGS (Other Identifier)

17105 (Other Identifier)

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 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.

Enrollment: 47 patients

Sex: All

Ages: 21 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 18.0 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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47 participants in 2 patient groups

Tirzepatide Test

Experimental group

Description:

Participants received single dose of 5 milligram (mg) Tirzepatide by subcutaneous injection (SC) via an autoinjector (AI) in one of two study periods.

Treatment:

Drug: Tirzepatide

Device: Auto-injector (AI)

Tirzepatide Reference

Experimental group

Description:

Participants received single dose of 5mg Tirzepatide by subcutaneous injection (SC) via a prefilled syringe (PFS) in one of two study periods.

Treatment:

Drug: Tirzepatide

Device: Prefilled syringe (PFS)