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CompletedPhase 1Results posted

A Study of Dulaglutide in Healthy Participants

Relative Bioavailability of an Investigational Single Dose of Dulaglutide After Subcutaneous Administration by a Single Dose Pen Compared to a Prefilled Syringe in Healthy Subjects

Asset

Dulaglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

Enrollment

27

actual

Study population

Healthy volunteers

Key I/E criterion

Healthy volunteers

Primary endpoints

AUC From Zero to Infinity (AUC[0-∞]) of DulaglutidePK: Maximum Observed Drug Concentration (Cmax) of Dulaglutide

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT03363906
Org study ID16878
Secondary IDH9X-MC-GBGMEli Lilly and Company

Timeline

Milestones

Study first posted2017-12-06actual
Study start2017-12-07actual
Primary completion2018-06-06actual
Study completion2018-06-06actual
Last update posted2019-07-29actual
Results first posted2019-07-29actual

Assets

Investigational agents

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersAccepted

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

Endpoints (4)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Safety / tolerability / PK

4 endpoints
Primary/registry result

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

AUC₀–∞

concentration, descriptive

Posted result

GroupValue (geometric_mean), nanogram.hour/milliliter (ng.h/mL)95% CI
Dulaglutide (Reference)37400
Dulaglutide (Test)40000
Ratio Geometric Least Squares (LS) Mean1.0490% CI0.9491.14p0.473Mixed Models Analysis
Primary/registry result

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

Cmax

concentration, descriptive

Posted result

GroupValue (geometric_mean), nanogram/milliliter (ng/mL)95% CI
Dulaglutide (Reference)213
Dulaglutide (Test)240
Mean Difference (Final Values)1.1490% CI0.9931.30p0.119ANOVA
Primary/protocol endpoint

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

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

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

Cmax

concentration, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.