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:
2025-12-26 @ 11:48 AM
Ignite Modification Date:
2025-12-26 @ 11:48 AM
NCT ID:
NCT06297616
Eligibility Criteria:
Inclusion Criteria:
* Male or female participants who agree to contraception requirements
* Have a body mass index (BMI) within the range of 27 to 40 kg/m², inclusive
* Have had a stable weight for the 3 months
Exclusion Criteria:
* Have a history of significant atopy (severe allergic manifestations), multiple or severe drug allergies, or severe posttreatment hypersensitivity reactions
* Have a history or presence of psychiatric disorders, including a history of major depressive disorder or severe psychiatric disorders such as schizophrenia, bipolar disorder within the last 3 years
* Have been diagnosed with Type 1 or Type 2 Diabetes Mellitus
* Have a history of chronic medical conditions involving the heart, liver, or kidneys
* Have a history of any malignancy within the past 5 years
* Have a history or presence of a GI disorder
* Have had within the last 6 months, or plan to have during the study, a device-based or surgical treatment use for obesity
* Have been treated, or plan to be treated, with prescription medications or other non-approved drugs intended to promote weight loss, within 3 months prior to screening
* For participants in Part B, have previously received tirzepatide within 6 months prior to screening
* For participants in Part B, have a personal or family history of medullary thyroid carcinoma, or have multiple endocrine neoplasia syndrome type 2
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06297616
Study Brief:
Protocol Section:
NCT06297616