Healthy
Conditions
Brief summary
The main purpose of this study is to look at the amount of the study drug, tirzepatide, that gets into the blood stream and how long it takes the body to get rid of it when given using two different devices. The study will also evaluate the safety and tolerability of tirzepatide and information about any side effects experienced will be collected. For each participant, the total duration of the study will be approximately 14 weeks, including screening.
Interventions
DRUGTirzepatide
Administered SC
DEVICESingle Dose Pen
Used to administer tirzepatide SC
DEVICEMulti-use Prefilled Pen
Used to administer tirzepatide 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 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy males or non-pregnant females as determined by medical history, physical examination, and other screening procedures * Body mass index (BMI) between 18.5 and 30.0 kilograms per meter squared (kg/m²), inclusive, at screening * Have blood pressure, pulse rate, blood and urine laboratory test results that are acceptable for the study * Are agreeable to receiving study treatment by injections under the skin * Are agreeable to following study contraception requirements
Exclusion criteria
* Have or used to have health problems that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study * Smoke more than the equivalent of 10 cigarettes per day * Is a known user of drugs of abuse
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of Tirzepatide | Predose, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 336, and 480 hours post Day 1 dose and on Day 36 of each study period. | PK: Cmax of Tirzepatide |
| PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Time t, Where t is the Last Time Point With a Measurable Concentration (AUC[0-t]) of Tirzepatide | Predose, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 336, and 480 hours post Day 1 dose and on Day 36 of each study period. | PK: AUC(0-t) of Tirzepatide |
| PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Tirzepatide | Predose, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 336, and 480 hours post Day 1 dose and on Day 36 of each study period. | PK: AUC(0-∞) of Tirzepatide |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sequence 1: Tirzepatide by SDP / MUPFP Participants received a single dose of 5 mg tirzepatide administered SC via an SDP in Period 1 followed by a single dose of 5 mg tirzepatide administered SC via a MUPFP in Period 2.
There was a washout period of at least 35 days between tirzepatide dose administrations. | 34 |
| Sequence 2: Tirzepatide by MUPFP / SDP Participants received a single dose of 5 mg tirzepatide administered SC via a MUPFP in Period 1 followed by a single dose of 5 mg tirzepatide administered SC via an SDP in Period 2.
There was a washout period of at least 35 days between tirzepatide dose administrations. | 31 |
| Total | 65 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 1 | Adverse Event | 2 | 0 |
| Period 1 | Physician Decision | 1 | 0 |
Baseline characteristics
| Characteristic | Sequence 1: Tirzepatide by SDP / MUPFP | Total | Sequence 2: Tirzepatide by MUPFP / SDP |
|---|---|---|---|
| Age, Continuous | 41.10 years STANDARD_DEVIATION 13.32 | 41.10 years STANDARD_DEVIATION 13.79 | 41.10 years STANDARD_DEVIATION 14.52 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 16 Participants | 33 Participants | 17 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 18 Participants | 32 Participants | 14 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 6 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 29 Participants | 58 Participants | 29 Participants |
| Region of Enrollment United States | 34 Participants | 65 Participants | 31 Participants |
| Sex: Female, Male Female | 18 Participants | 35 Participants | 17 Participants |
| Sex: Female, Male Male | 16 Participants | 30 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 65 | 0 / 62 |
| other Total, other adverse events | 38 / 65 | 28 / 62 |
| serious Total, serious adverse events | 0 / 65 | 0 / 62 |
Outcome results
Primary
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Tirzepatide
PK: Cmax of Tirzepatide
Time frame: Predose, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 336, and 480 hours post Day 1 dose and on Day 36 of each study period.
Population: All participants who received at least one dose of study drug and had evaluable PK data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Tirzepatide (SDP) | Pharmacokinetics (PK): Maximum Concentration (Cmax) of Tirzepatide | 647 nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 31 |
| Tirzepatide (MUPFP) | Pharmacokinetics (PK): Maximum Concentration (Cmax) of Tirzepatide | 524 nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 27 |
Primary
PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Tirzepatide
PK: AUC(0-∞) of Tirzepatide
Time frame: Predose, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 336, and 480 hours post Day 1 dose and on Day 36 of each study period.
Population: All participants who received at least one dose of study drug and had evaluable data for this outcome.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Tirzepatide (SDP) | PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Tirzepatide | 126000 ng*h/mL | Geometric Coefficient of Variation 22 |
| Tirzepatide (MUPFP) | PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Tirzepatide | 119000 ng*h/mL | Geometric Coefficient of Variation 22 |
Primary
PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Time t, Where t is the Last Time Point With a Measurable Concentration (AUC[0-t]) of Tirzepatide
PK: AUC(0-t) of Tirzepatide
Time frame: Predose, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 336, and 480 hours post Day 1 dose and on Day 36 of each study period.
Population: All participants who received at least one dose of study drug and had evaluable PK data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Tirzepatide (SDP) | PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Time t, Where t is the Last Time Point With a Measurable Concentration (AUC[0-t]) of Tirzepatide | 124000 nanogram *hour per milliliter (ng*h/mL) | Geometric Coefficient of Variation 23 |
| Tirzepatide (MUPFP) | PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Time t, Where t is the Last Time Point With a Measurable Concentration (AUC[0-t]) of Tirzepatide | 118000 nanogram *hour per milliliter (ng*h/mL) | Geometric Coefficient of Variation 22 |