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 @ 7:46 PM
Ignite Modification Date:
2025-12-24 @ 7:46 PM
NCT ID:
NCT06716203
Eligibility Criteria:
Inclusion Criteria:
* ☑ Have been diagnosed with type 2 diabetes mellitus (T2DM);
* Have a BMI ≥23 kilograms per meter squared (kg/m²) at screening;
* Be of stable weight (± 5%) for at least 3 months before screening;
* Have HbA1c between ≥7.5% and ≤11.0%；
* Fasting Plasma Glucose (FPG) ≤ 15.0 mmoL/L.
Exclusion Criteria:
* ■ Previous diagnosis of type 1 diabetes, special type diabetes ;
* There are malignant tumors within 5 years before screening, or patients are in latent of clinical malignant tumors (except patients with skin basal cell carcinoma and squamous cell carcinoma, cervical carcinoma in situ, prostate carcinoma in situ or papillary thyroid carcinoma who have no recurrence after surgery).
* Have had chronic or acute pancreatitis any time prior to study entry;
* Known allergic constitution (allergy to 3 or more kinds of food or drugs), or allergy to GLP-1 receptor agonists, or severe allergic diseases (asthma, urticaria, eczematous dermatitis, etc.) at screening;
* Mentally incapacitated or speech-impaired;
* Suspected or confirmed history of alcohol or drug abuse;
* Pregnant or lactating woman;
* The investigator considers that there are any other conditions that make it inappropriate to participate in this study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06716203
Study Brief:
Protocol Section:
NCT06716203