A Study of Dulaglutide in Healthy Participants

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

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).

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Dulaglutide (Reference); Drug: Dulaglutide (Test)

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75247
      • Covance Dallas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dulaglutide (Reference); Dulaglutide 4.5 mg administered subcutaneously (SC) in 3 prefilled syringes (PFS) in one of two study periods	Drug: Dulaglutide (Reference); Administered SC; Other Names: LY2189265
Experimental: Dulaglutide (Test); Dulaglutide 4.5 mg administered SC in 1 single dose pen (SDP) in one of two study periods	Drug: Dulaglutide (Test); Administered SC; Other Names: LY2189265

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2017
• Primary Completion (Actual): June 6, 2018
• Study Completion (Actual): June 6, 2018

Study Registration Dates

• First Submitted: December 1, 2017
• First Submitted That Met QC Criteria: December 1, 2017
• First Posted (Actual): December 6, 2017

Study Record Updates

• Last Update Posted (Actual): July 29, 2019
• Last Update Submitted That Met QC Criteria: July 26, 2019
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Immunologic Factors; Dulaglutide; Immunoglobulin Fc Fragments
• Other Study ID Numbers: 16878; H9X-MC-GBGM (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No