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 @ 7:37 PM
Ignite Modification Date:
2025-12-24 @ 7:37 PM
NCT ID:
NCT06911203
Eligibility Criteria:
Inclusion Criteria:
* ● Able and willing to provide a written informed consent.
* Male or female subjects, 18-65 years of age at the time of signing informed consent.
* At screening visit, 35.0 ﹤BMI﹤ 45.0 kg/m2;
* Diet and exercise control for at least 3 months before screening visit, and be of stable weight (± 5%) self-reported change within the last 3 months.
Exclusion Criteria:
* ●History of chronic or acute pancreatitis.
* History of severe drug allergy or specific allergic disease or severe allergies.
* Family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2(MEN-2).
* History of malignant tumors \[except carcinoma in situ with no recurrence within 5 years (except for malignant melanoma in situ), skin basal cell carcinoma and squamous cell carcinoma\].
* Suspected or confirmed history of alcohol or drug abuse;
* Any chronic infections likely to interfere with study conduct or interpretation such as hepatitis B (HBV), hepatitis C (HCV), human immunodeficiency virus (HIV) or treponema pallidum (TP).
* Donation or loss of 400 mL or more of blood within 3 months prior to screening, or blood donation during screening or within 3 months after the end of the trial.
* Pregnant or lactating woman.
* Any disorder, unwillingness, or inability not covered by any of the other exclusion criteria, which in the Investigator's opinion, might jeopardize the participant's safety or compliance with the protocol.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06911203
Study Brief:
Protocol Section:
NCT06911203