A Study of Dulaglutide in Healthy Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Dulaglutide (Reference); Drug: Dulaglutide (Test)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03363906

16878

H9X-MC-GBGM (Other Identifier)

Details and patient eligibility

About

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).

Enrollment: 27 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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27 participants in 2 patient groups

Dulaglutide (Reference)

Experimental group

Description:

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

Treatment:

Drug: Dulaglutide (Reference)

Dulaglutide (Test)

Experimental group

Description:

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

Treatment:

Drug: Dulaglutide (Test)