A Study of Dulaglutide in Healthy Participants

Study Overview
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Brief Summary
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The purpose of this study is to evaluate a new formulation of dulaglutide (study drug) administered under the skin as one injection using a single dose pen compared to three injections using a pre filled syringe. This study will evaluate how much of the study drug enters the body and how long it takes the body to get rid of it. Information about any side effects that may occur will also be collected. The study will last about 84 days, including screening and will require overnight stays in the clinical research unit (CRU).

Official Title
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Relative Bioavailability of an Investigational Single Dose of Dulaglutide After Subcutaneous Administration by a Single Dose Pen Compared to a Prefilled Syringe in Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: Dulaglutide (Reference)
* Drug: Dulaglutide (Test)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Overtly healthy as determined by medical history and physical examination at time of screening Have a body mass index of greater than or equal to (≥) 23 kilograms per meter squared (kg/m²) inclusive Exclusion Criteria: Have known allergies to dulaglutide, glucagon-like peptide-1 (GLP-1) related compounds, or any components of the formulation Have family history of medullary thyroid cancer (MTC) or a genetic condition that predisposes to MTC Have a history or presence of pancreatitis (history of chronic pancreatitis or idiopathic acute pancreatitis) or gastrointestinal disorder (e.g., relevant esophageal reflux or gall bladder disease) or any gastrointestinal disease which impacts gastric emptying (e.g., gastric bypass surgery, pyloric stenosis, with the exception of appendectomy) or could be aggravated by GLP-1 analogs

Ages Eligible for Study
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Minimum Age: 18 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: Dulaglutide (Reference)<br>Dulaglutide 4.5 mg administered subcutaneously (SC) in 3 prefilled syringes (PFS) in one of two study periods | Drug: Dulaglutide (Reference)<br>* Administered SC<br>* Other names: LY2189265;|
| Experimental: Dulaglutide (Test)<br>Dulaglutide 4.5 mg administered SC in 1 single dose pen (SDP) in one of two study periods | Drug: Dulaglutide (Test)<br>* Administered SC<br>* Other names: LY2189265;|

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 From Zero to Infinity (AUC[0-∞]) of Dulaglutide | Pharmacokinetics was assessed in healthy participants to determine the area under the concentration time curve from 0 to infinity (AUC[0-∞]) of Dulaglutide. | Periods 1 and 2: Day 1 - 8 and Day 15: Predose, 24, 48, 72,96,120,144,168, and 336 hours post dose; Follow Up: Day 28 | 
| PK: Maximum Observed Drug Concentration (Cmax) of Dulaglutide | Pharmacokinetics was assessed in healthy participants to determine the maximum observed drug concentration (Cmax) of Dulaglutide. | Periods 1 and 2: Day 1 - 8 and Day 15: Predose, 24, 48, 72,96,120,144,168, and 336 hours post dose; Follow Up : Day 28 |