A Study of Dulaglutide in Healthy Participants

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Dulaglutide (Reference); Drug: Dulaglutide (Test)

• Registration Number: NCT03363906
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-12-01
• Study First Submitted QC: 2017-12-01
• Study First Posted: 2017-12-06
• Study Start: 2017-12-07
• Primary Completion: 2018-06-06
• Study Completion: 2018-06-06
• Status Verified: 2018-07
• Results First Submitted: 2019-05-24
• Results First Submitted QC: 2019-07-26
• Last Update Submitted: 2019-07-26
• Results First Posted: 2019-07-29
• Last Update Posted: 2019-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Dulaglutide (Reference)	Dulaglutide (Reference)	Dulaglutide 4.5 mg administered subcutaneously (SC) in 3 prefilled syringes (PFS) in one of two study periods
Dulaglutide (Test)	Dulaglutide (Test)	Dulaglutide 4.5 mg administered SC in 1 single dose pen (SDP) in one of two study periods

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero 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	Pharmacokinetics was assessed in healthy participants to determine the area under the concentration time curve from 0 to infinity (AUC\[0-∞\]) of Dulaglutide.
PK: 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	Pharmacokinetics was assessed in healthy participants to determine the maximum observed drug concentration (Cmax) of Dulaglutide.

Trial Locations

Locations (1)

Covance Dallas; 🇺🇸 Dallas, Texas, United States