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 @ 11:24 PM
Ignite Modification Date:
2025-12-24 @ 11:24 PM
NCT ID:
NCT06929156
Eligibility Criteria:
Inclusion Criteria:
* √ Age 18-65 years on the date of signing informed consent (inclusive);
* Body mass index (BMI) within the range of 19.0-30.0 kg/m2 (inclusive);.
* Stable renal function, assessed by two eGFR during screening (apart at least 3 days);
* Diagnosed as stable, chronic renal disease for at least 3 months.
* Renal function, assessed by estimated glomerular filtration rate at screening (eGFR):
1. Normal renal function: 90-129 mL/min (inclusive);
2. Mild impairment: 60-89 mL/min (inclusive);
3. Moderate impairment: 30-59 mL/min (inclusive);
4. Severe impairment: 15-29 mL/min (inclusive);
Exclusion Criteria:
* ● Allergic constitution includes severe drug allergy or history of drug allergy;
* Have a personal or family history of medullary thyroid carcinoma or have multiple endocrine neoplasia syndrome type 2; Have a history or presence of pancreatitis;
* Participants in clinical trials of any drug or medical device in the 3 months prior to screening;.
* Suspected or confirmed history of alcohol or drug abuse;
* Hepatitis B surface antigen (HBsAg), HIV antibody detection, hepatitis C virus antibody (HCVAb), treponema pallidum specific antibody detection, positive;
* Donation or loss of 200 mL or more of blood within 3 months prior to screening, or blood donation during screening or within 1 months after the end of the trial;
* Pregnant or Breast-feeding women;
* The investigator considers that the participant has any other factors that would make it inappropriate to participate in this study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06929156
Study Brief:
Protocol Section:
NCT06929156