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

Inclusion criteria

Participants who meet all of the following criteria will be eligible to participate in this study:

• Adults aged 18 to 75.
• Diagnosis of type 2 diabetes for at least 6 months.
• HbA1c between 7.0% and 10.5%.
• Body mass index (BMI) between 23 and 50 kg/m².
• Body weight stable for the past 3 months before joining.
• Stable dose of metformin (≥1000 mg/day), with or without SGLT2i, for ≥3 months.
• Women of childbearing potential (WOCBP): highly effective contraception ≥6 months prior to screening, throughout study, and 90 days post-last dose; negative pregnancy test within 24 hrs of first dose; no intent to donate sperm/ova
• Agrees to avoid grapefruit/grapefruit products

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).