Healthy
Conditions
Brief 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).
Interventions
DRUGDulaglutide (Reference)
Administered SC
DRUGDulaglutide (Test)
Administered SC
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Dulaglutide | 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 was assessed in healthy participants to determine the area under the concentration time curve from 0 to infinity (AUC\[0-∞\]) of Dulaglutide. |
| PK: Maximum Observed Drug Concentration (Cmax) of Dulaglutide | 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 was assessed in healthy participants to determine the maximum observed drug concentration (Cmax) of Dulaglutide. |
Countries
United States
Participant flow
Pre-assignment details
Participants were randomly assigned into different treatment sequences. Participants in Treatment Sequence A will receive Treatment 1 then Treatment 2. Participants in Treatment Sequence B will receive Treatment 2 then Treatment 1.
Participants by arm
| Arm | Count |
|---|---|
| Dulaglutide Test and Reference Dulaglutide 4.5 mg administered SC in 3 prefilled syringes and 1 single dose pen in one of two study periods. | 27 |
| Total | 27 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 1 (Reference or Test) | Adverse Event | 1 | 2 |
| Period 2 (Test or Reference) | Adverse Event | 2 | 0 |
| Period 2 (Test or Reference) | Lost to Follow-up | 1 | 0 |
| Period 2 (Test or Reference) | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Dulaglutide Test and Reference |
|---|---|
| Age, Continuous | 41.7 years STANDARD_DEVIATION 10.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 23 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 22 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 5 Participants |
| Region of Enrollment United States | 27 Participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 23 |
| other Total, other adverse events | 15 / 24 | 14 / 23 |
| serious Total, serious adverse events | 0 / 24 | 0 / 23 |
Outcome results
Primary
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Dulaglutide
Pharmacokinetics was assessed in healthy participants to determine the area under the concentration time curve from 0 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
Population: All randomized participants who received at least one dose of study drug and had evaluable PK data in the PFS or SDP arms.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Dulaglutide (Reference) | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Dulaglutide | 37400 nanogram.hour/milliliter (ng.h/mL) | Geometric Coefficient of Variation 38 |
| Dulaglutide (Test) | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Dulaglutide | 40000 nanogram.hour/milliliter (ng.h/mL) | Geometric Coefficient of Variation 33 |
p-value: 0.47390% CI: [0.949, 1.14]Mixed Models Analysis
Primary
PK: Maximum Observed Drug Concentration (Cmax) of Dulaglutide
Pharmacokinetics was assessed in healthy participants to determine the 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
Population: All randomized participants who received at least one dose of study drug and had evaluable PK data in the PFS or SDP arms.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Dulaglutide (Reference) | PK: Maximum Observed Drug Concentration (Cmax) of Dulaglutide | 213 nanogram/milliliter (ng/mL) | Geometric Coefficient of Variation 41 |
| Dulaglutide (Test) | PK: Maximum Observed Drug Concentration (Cmax) of Dulaglutide | 240 nanogram/milliliter (ng/mL) | Geometric Coefficient of Variation 39 |
p-value: 0.11990% CI: [0.993, 1.3]ANOVA