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

Lead sponsor

Eli Lilly and Company

Asset

Dulaglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

Actual enrollment

Study population

Healthy volunteers

Eligibility highlights

•Healthy volunteers

Primary endpoints

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

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. 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

Dulaglutide

Who this study enrolls

Healthy volunteers

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

Group	Geometric mean · nanogram.hour/milliliter (ng.h/mL)	95% CI
Dulaglutide (Reference)	37400	-
Dulaglutide (Test)	40000	-

Ratio geometric least squares (ls) mean1.0490% CI0.949 - 1.14p0.473Mixed 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

Group	Geometric mean · nanogram/milliliter (ng/mL)	95% CI
Dulaglutide (Reference)	213	-
Dulaglutide (Test)	240	-

Mean difference (final values)1.1490% CI0.993 - 1.30p0.119ANOVA

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 6, 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 6, 2026 snapshot.