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:
2025-12-24 @ 3:39 PM
Ignite Modification Date:
2025-12-24 @ 3:39 PM
NCT ID:
NCT03486392
Eligibility Criteria:
Inclusion Criteria:
* Body mass index (BMI) greater than or equal to (\>=) 35 to less than or equal to (\<=) 50 kilogram per square meter (kg/m\^2) at the screening visit
* Stable weight (that is, change of \<= 5 percent \[%\] within 12 weeks before screening based on medical history)
* Women must be either: (a) Postmenopausal, or (b) Permanently sterilized or otherwise be incapable of pregnancy, or (c) Heterosexually active and practicing a highly effective method of birth control, or (d) Not heterosexually active
* Woman of childbearing potential have a negative pregnancy test at screening
* Willing and able to adhere to specific the prohibitions and restrictions
Exclusion Criteria:
* History of obesity with a known secondary cause (for example, Cushing's disease/syndrome)
* History of Type 1 diabetes mellitus, Type 2 diabetes mellitus (T2DM), diabetic ketoacidosis (DKA), pancreas or beta-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy
* Has a Hemoglobin A1c (HbA1c) of \>= 6.5% or fasting plasma glucose (FPG) \>= 126 milligrams per deciliter (mg/dL) (\>= 7.0 millimoles per liter \[mmol/L\]) at screening
* Screening calcitonin of \>= 50 picograms per milliliter (pg/mL) personal history or family history of medullary thyroid cancer, or of multiple endocrine neoplasia syndrome type 2 (MEN 2), regardless of time prior to screening
* History of glucagonoma
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT03486392
Study Brief:
Protocol Section:
NCT03486392