Status:
COMPLETED
A Study of LY3549492 in Healthy Participants
Lead Sponsor:
Eli Lilly and Company
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The main purpose of this study is to evaluate the safety and tolerability of LY3549492 in healthy participants. The blood tests will be performed to check how much LY3549492 gets into the bloodstream ...
Eligibility Criteria
Inclusion
- Healthy Males and females (excluding women of childbearing potential at the time of signing the informed consent)
- Glycated hemoglobin (HbA1c) value of \<6.5% at screening
- Body mass index (BMI) within the range 20 to 40 kilograms per square meter (kg/m²), inclusive
- Capable of giving signed informed consent form (ICF)
Exclusion
- Have obesity induced by endocrine disorders such as Cushing's syndrome or Prader-Willi syndrome.
- Have significant history of or current cardiovascular, respiratory, hepatic, renal, Gastro-intestine (GI) (including cholecystectomy with no sequelae, GI disease that significantly impact gastric emptying or motility, such as severe gastroparesis or pyloric stenosis even if treated), endocrine, hematological, psychiatric or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data.
- Have undergone any form of bariatric surgery.
- Have a history or presence of pancreatitis (history of chronic pancreatitis or idiopathic acute pancreatitis), elevation in serum amylase or lipase (\>2.5 fold the upper limit of normal (ULN)).
- Have a personal or family history of medullary thyroid carcinoma or have Multiple Endocrine Neoplasia Syndrome Type 2.
- Have a serum calcitonin level of ≥20 nanogram/liter (ng/L) at screening, if estimated glomerular filtration rate is ≥60 milliliter/minute/1.73 square meter (mL/min/1.73 m2).
- Have an active or history of malignancy within 5 years prior to screening, except for basal cell or squamous epithelial carcinomas of the skin or in situ carcinoma of the uterine cervix that have been resected with no evidence or recurrence or metastatic disease for at least 3 years.
- Have known liver disease, obvious clinical signs, or symptoms of liver disease, acute or chronic hepatitis, or have elevations in aminotransferases (alanine aminotransferase \[ALT\] and aspartate aminotransferase \[AST\]) greater than 2 times \[ULN\]).
- Have total bilirubin level (TBL) \>1.5 × ULN (except for participants diagnosed with Gilbert's syndrome).
- Have serum triglyceride \>500 milligram/deciliter (mg/dL) at screening.
Key Trial Info
Start Date :
February 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 10 2022
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT04758234
Start Date
February 22 2021
End Date
January 10 2022
Last Update
February 9 2022
Active Locations (1)
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1
Covance Dallas
Dallas, Texas, United States, 75247