A Study of CX11 Tablets in Patients With Type 2 Diabetes Mellitus

Exclusion Criteria

• •Participants who meet any of the following criteria will be excluded from this study:
• •Anticipated initiation or change in concomitant medications (for more than 14 consecutive days) known to affect weight or glucose metabolism (e.g. treatment with orlistat, thyroid hormones, or systemic corticosteroids).
• •Type 1 diabetes or a history of diabetic ketoacidosis.
• •Use of any GLP-1 receptor agonist within the past 6 months, or any prior exposure to CX11.
• •Use of insulin to control blood sugar within the past 12 months.
• •More than one episode of severe low blood sugar, with awareness of hypoglycemia symptoms.
• •Cardiovascular or cerebrovascular conditions within the past 6 months:
• •* Heart attack, coronary angioplasty, or bypass surgery (diagnostic angiography allowed).
• •* Valvular heart disease or prior heart valve repair surgery.
• •* Unstable angina.
• •* Transient ischemic attack (TIA) or stroke.
• •* Decompensated heart failure (NYHA Class III or IV).
• •* ECG abnormalities indicating significant safety risk, such as supraventricular tachycardia, torsades de pointes, second- or third-degree AV block, myocardial infarction, QTcF \> 450 ms in males or \> 470 ms in females, PR interval \> 220 ms.
• •* Poorly controlled hypertension at screening: systolic ≥ 180 mmHg or diastolic ≥ 100 mmHg.
• •Pancreatic or gallbladder conditions:
• •* Acute or chronic pancreatitis.
• •* Symptomatic gallbladder disease (previous cholecystectomy is allowed).
• •* Pancreatic injury or risk factors that increase pancreatitis risk.
• •Thyroid conditions:
• •* Poorly controlled abnormal thyroid function on a stable dose before screening.
• •* Clinically significant abnormal thyroid test results at screening.
• •* Personal or first-degree family history of medullary thyroid carcinoma or multiple endocrine neoplasia (MEN) type 2A or 2B.
• •Cancer history:
• •* Malignancy within the past 5 years, regardless of recurrence or metastasis. Exceptions: localized basal cell skin cancer, low-risk prostate cancer, cervical carcinoma in situ, or high-grade prostatic intraepithelial neoplasia.
• •Gastrointestinal conditions or treatments that may affect drug absorption:
• •* Abnormal gastric emptying (e.g., gastric outlet obstruction).
• •* Severe chronic gastrointestinal disease, including active ulcer within 6 months.
• •* Crohn's disease, ulcerative colitis, or other inflammatory bowel diseases.
• •* Prior gastrointestinal surgery (except polypectomy and appendectomy).
• •* Long-term use of drugs that directly affect gastrointestinal motility (e.g., mosapride, cisapride).
• •Liver disease:
• •* Active liver disease other than nonalcoholic fatty liver.
• •* Chronic active hepatitis B or C.
• •* Primary biliary cirrhosis.
• •Eye disease:
• •* Uncontrolled or potentially unstable diabetic retinopathy or maculopathy.
• •Abnormal lab results at screening:
• •* eGFR \< 60 mL/min/1.73 m² (CKD-EPI).
• •* ALT or AST \> 2.5 × upper limit of normal (ULN).
• •* Total bilirubin \> 1.5 × ULN (except known Gilbert's syndrome).
• •* Serum amylase or lipase \> 1.5 × ULN.
• •* Fasting triglycerides \> 5.7 mmol/L.
• •* TSH \> 1.5 × ULN or \< 1.0 × LLN.
• •* Calcitonin ≥ 20 ng/L.
• •* Hemoglobin \< 110 g/L (male) or \< 100 g/L (female).