A Study of Dulaglutide in Healthy Participants

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-07

Study Completion Date

2018-06-06

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).

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Dulaglutide (Reference)

Dulaglutide 4.5 mg administered subcutaneously (SC) in 3 prefilled syringes (PFS) in one of two study periods

Group Type EXPERIMENTAL

Dulaglutide (Reference)

Intervention Type DRUG

Administered SC

Dulaglutide (Test)

Dulaglutide 4.5 mg administered SC in 1 single dose pen (SDP) in one of two study periods

Group Type EXPERIMENTAL

Dulaglutide (Test)

Intervention Type DRUG

Administered SC

Interventions

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Dulaglutide (Reference)

Administered SC

Intervention Type DRUG

Dulaglutide (Test)

Administered SC

Intervention Type DRUG

Other Intervention Names

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LY2189265 LY2189265

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes