Status:
COMPLETED
A Study of Tirzepatide (LY3298176) in Healthy Participants
Lead Sponsor:
Eli Lilly and Company
Conditions:
Healthy
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
This study has four 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 a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 19 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 27 2018
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT03375463
Start Date
December 19 2017
End Date
December 27 2018
Last Update
February 5 2024
Active Locations (1)
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1
Covance
Dallas, Texas, United States, 75247