Phase 1
Completed N=27
A Study of Dulaglutide in Healthy Participants
Healthy
Source: ClinicalTrials.gov NCT03363906 ↗
Enrolled (actual)
27
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcomePrimary: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Dulaglutide — 37400; 40000 nanogram.hour/milliliter (ng.h/mL) — p=0.473
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Dulaglutide |
37400; 40000 | 0.473 |
| PRIMARY PK: Maximum Observed Drug Concentration (Cmax) of Dulaglutide |
213; 240 | 0.119 |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03363906). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.