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A Study of Dulaglutide in Healthy Participants

NCT03363906 ↗

Phase 1 Completed 27 enrolled Eli Lilly and Company
RandomizedCrossoverOpen-labelBasic science

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).

Timeline

Start
2017-12-07
Primary completion
2018-06-06
Completion
2018-06-06

Outcome

Missed primary endpoint

registry analysis (superiority test); Dulaglutide (Reference) vs Dulaglutide (Test); p = 0.473; Ratio Geometric Least Squares (LS) Mean 1.04 (90% CI 0.949 to 1.14); Mixed Models Analysis NCT03363906 ↗

registry analysis (superiority test); Dulaglutide (Reference) vs Dulaglutide (Test); p = 0.119; Mean Difference (Final Values) 1.14 (90% CI 0.993 to 1.30); ANOVA NCT03363906 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Dulaglutide Peptide 4.5 mg Subcutaneous

Indications

No indication recorded.