A Study of Tirzepatide (LY3298176) in Healthy Participants
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 2/6/2019 |
| Start Date: | December 19, 2017 |
| End Date: | December 27, 2018 |
Pharmacokinetics, Safety, and Tolerability of a Solution Formulation of LY3298176 in Healthy Subjects
This study has three parts. Each participant will enroll in one part.
Part A: The purpose of Part A is to compare study drug tirzepatide solution formulation to a
powder formulation mixed with water and given subcutaneously (SC) (just under the skin). Part
A will measure how much of the study drug gets into the blood stream and how long it takes
the body to get rid of it.
Part B: The purpose of Part B is to evaluate the safety and tolerability of tirzepatide
intravenous (IV) formulation when administered into a vein.
Part C: The purpose of Part C is to evaluate the safety and tolerability of tirzepatide
following multiple SC weekly doses of a solution.
This study will last approximately 70 days for Part A or Part B and 92 days for Part C. This
does not include screening. Screening is required within 28 days prior to the start of the
study.
Part A: The purpose of Part A is to compare study drug tirzepatide solution formulation to a
powder formulation mixed with water and given subcutaneously (SC) (just under the skin). Part
A will measure how much of the study drug gets into the blood stream and how long it takes
the body to get rid of it.
Part B: The purpose of Part B is to evaluate the safety and tolerability of tirzepatide
intravenous (IV) formulation when administered into a vein.
Part C: The purpose of Part C is to evaluate the safety and tolerability of tirzepatide
following multiple SC weekly doses of a solution.
This study will last approximately 70 days for Part A or Part B and 92 days for Part C. This
does not include screening. Screening is required within 28 days prior to the start of the
study.
Inclusion Criteria:
- Overtly healthy males or females, as determined by medical history and physical
examination
- Male participants: agree to use an effective method of contraception for the duration
of the study and for 3 months following the last dose of investigational product
- Female participants: not of childbearing potential due to surgical sterilization
(hysterectomy or bilateral oophorectomy or tubal ligation) or menopause. Women with an
intact uterus are deemed postmenopausal if they are greater than or equal to (≥)45
years old and have not taken hormones or oral contraceptives within the last year and
had cessation of menses for at least 1 year. Or, have had at least 6 months of
amenorrhea with follicle-stimulating hormone levels consistent with a postmenopausal
state
- Have a body mass index of 18.5 to 32.0 kilograms per meter squared (kg/m²) inclusive
Exclusion Criteria:
- Currently enrolled in a clinical trial involving an investigational product or any
other type of medical research judged not to be scientifically or medically compatible
with this study
- Received treatment with a drug that has not received regulatory approval for any
indication within 30 days of screening
- Have a history of heart block, or a pulse rate (PR) interval greater than (>)200
milliseconds (msec), or any abnormality in the 12-lead electrocardiogram (ECG) at
screening that, in the opinion of the investigator, increases the risks associated
with participating in the study
- Have a significant history of or current cardiovascular (myocardial infarction,
congestive heart failure, cerebrovascular accident, venous thromboembolism, etc.),
respiratory, hepatic, renal, gastrointestinal (GI), endocrine, hematological
(including history of thrombocytopenia), or neurological disorders capable of
significantly altering the absorption, metabolism, or elimination of drugs, or of
constituting a risk when taking the study medication, or interfering with the
interpretation of data
We found this trial at
1
site
