Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-25 @ 2:37 AM
NCT ID:
NCT04758234
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT04758234
Study Brief:
Protocol Section:
NCT04758234