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

Korábbi kezelés

• Use of any GLP-1 receptor agonist within the past 6 months, or any prior exposure to CX11.
• 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.
• 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).

Más betegség

• Type 1 diabetes or a history of diabetic ketoacidosis.
• 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.
• 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.

Laborértékek

• 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).
• 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).

Egyéb

• Participants who meet any of the following criteria will be excluded from this study:
• 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.

• 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