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Trial · Interventional

CompletedPhase 1Results postedRegistry data

A Study of Dulaglutide in Healthy Participants

NCTNCT03363906 (opens ClinicalTrials.gov in a new tab)Other id16878Other idH9X-MC-GBGM
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Overview

Status
Completed
Phase
Phase 1
Enrollment
27 participants (actual)
Sponsor
Eli Lilly and Company · Industry
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
7 Dec 2017
Primary completion
6 Jun 2018
Completion
6 Jun 2018
First posted
6 Dec 2017
Last update posted
29 Jul 2019
Conditions
Healthy

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201720182019
  1. Ph 1

    A Study of Dulaglutide in Healthy Participants

    NCT03363906

    7 Dec 2017 to 6 Jun 2018

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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).

Interventions

  • Dulaglutide (Reference)Drug
  • Dulaglutide (Test)Drug

Arms2

  • Experimental

    Dulaglutide (Reference)

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

  • Experimental

    Dulaglutide (Test)

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

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Dulaglutide

    Time frame · 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

    Registry description

    Pharmacokinetics was assessed in healthy participants to determine the area under the concentration time curve from 0 to infinity (AUC\[0-∞\]) of Dulaglutide.

  2. PK: Maximum Observed Drug Concentration (Cmax) of Dulaglutide

    Time frame · 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

    Registry description

    Pharmacokinetics was assessed in healthy participants to determine the maximum observed drug concentration (Cmax) of Dulaglutide.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeGeometric mean· 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 (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Dulaglutide

GroupValue (nanogram.hour/milliliter (ng.h/mL))Spread
Dulaglutide (Reference)3740038
Dulaglutide (Test)4000033
Primary outcomeGeometric mean· 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

GroupValue (nanogram/milliliter (ng/mL))Spread
Dulaglutide (Reference)21341
Dulaglutide (Test)24039

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Dulaglutide (Reference)Dulaglutide 4.5 mg administered SC in 3 prefilled syringes in one of two study periods0 / 240 / 2415 / 24
Dulaglutide (Test)Dulaglutide 4.5 mg administered SC in 1 single dose pen in one of two study periods0 / 230 / 2314 / 23

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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

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