Healthy
Conditions
Brief summary
The purpose of this study is to compare the amount of tirzepatide that gets into the blood stream and how long it takes the body to get rid of it, when given as a solution formulation via an autoinjector versus a conventional prefilled syringe. The tolerability of tirzepatide will also be evaluated and information about any adverse effects experienced will be collected. Screening is required within 28 days prior to the start of the study. For each participant, the total duration of the clinical trial will be about 14 weeks, including screening.
Interventions
DRUGTirzepatide
Administered SC
DEVICEPrefilled syringe (PFS)
PFS used to administer tirzepatide
DEVICEAuto-injector (AI)
AI used to administer tirzepatide
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy males or females of nonchildbearing potential as determined by medical history, physical examination, and other screening procedures * Are between the body mass index (BMI) of 18.0 and 32.0 kilograms per meter squared (kg/m²), inclusive, at screening * Are agreeable to receiving study treatment by injections under the skin
Exclusion criteria
* Have known allergies to tirzepatide or related compounds * Have a personal or family history of medullary thyroid carcinoma or have multiple endocrine neoplasia syndrome type 2 * Have a history or presence of pancreatitis (history of chronic pancreatitis or idiopathic acute pancreatitis), elevation in serum amylase or lipase or GI disorder (eg, relevant esophageal reflux or gall bladder disease) or any GI disease which impacts gastric emptying (eg, gastric bypass surgery, pyloric stenosis, with the exception of appendectomy) or could be aggravated by glucagon-like peptide-1 (GLP-1) analogs or dipeptidyl peptidase IV (DPP-IV) inhibitors * Have a prior history of malignant disease(s) in the past 5 years prior to screening * 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): Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide From Time Zero to Infinity (AUC0toinf) | Predose, 8hours(h), 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 168h, 336h , 480h, 864h postdose | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide from Time Zero to Infinity (AUC0toinf) was reported. |
| PK: Maximum Observed Plasma Concentration (Cmax) of Tirzepatide | Predose, 8hours(h), 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 168h, 336h , 480h, 864h postdose | PK: Maximum Observed Plasma Concentration (Cmax) of Tirzepatide was reported |
Countries
Singapore
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Participants Participants received 5mg of tirzepatide by SC injection administered by autoinjector or prefilled syringe on day 1 of each period as per the dosing sequence. | 47 |
| Total | 47 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 1 | Adverse Event | 1 | 2 |
| Period 1 | Physician Decision | 2 | 0 |
| Period 1 | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous | 44.6 years STANDARD_DEVIATION 11.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 47 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 47 Participants |
| Race (NIH/OMB) Black or African American | 0 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 | 0 Participants |
| Region of Enrollment Singapore | 47 Participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 42 | 0 / 44 |
| other Total, other adverse events | 40 / 42 | 42 / 44 |
| serious Total, serious adverse events | 0 / 42 | 1 / 44 |
Outcome results
Primary
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide From Time Zero to Infinity (AUC0toinf)
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide from Time Zero to Infinity (AUC0toinf) was reported.
Time frame: Predose, 8hours(h), 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 168h, 336h , 480h, 864h postdose
Population: All randomized participants who received at least one dose of study drug and had evaluable PK samples.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| 5 mg Tirzepatide AI | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide From Time Zero to Infinity (AUC0toinf) | 101000 Nanogram*hour per milliliter (ng*h/mL) | Geometric Coefficient of Variation 18 |
| 5 mg Tirzepatide PFS | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide From Time Zero to Infinity (AUC0toinf) | 104000 Nanogram*hour per milliliter (ng*h/mL) | Geometric Coefficient of Variation 18 |
Primary
PK: Maximum Observed Plasma Concentration (Cmax) of Tirzepatide
PK: Maximum Observed Plasma Concentration (Cmax) of Tirzepatide was reported
Time frame: Predose, 8hours(h), 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 168h, 336h , 480h, 864h postdose
Population: All randomized participants who received at least one dose of study drug and had evaluable PK samples.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| 5 mg Tirzepatide AI | PK: Maximum Observed Plasma Concentration (Cmax) of Tirzepatide | 530 Nanogram per Milliliter (ng/mL) | Geometric Coefficient of Variation 25 |
| 5 mg Tirzepatide PFS | PK: Maximum Observed Plasma Concentration (Cmax) of Tirzepatide | 556 Nanogram per Milliliter (ng/mL) | Geometric Coefficient of Variation 22 |