Phase 2 Clinical Study of MWN109 Tablets in Participants With Type 2 Diabetes Mellitus

Korábbi kezelés

• Use of insulin within 1 year prior to randomization (except for acute short-term use of ≤14 days).
• Diabetic ketoacidosis or hyperosmolar hyperglycemic state within 24 weeks prior to randomization.
• Grade 3 hypoglycemia within 12 months prior to randomization, or ≥3 episodes of Grade 2 hypoglycemia or hypoglycemia-related symptoms within 3 months prior to screening.
• Trauma, infection, or surgery within 12 weeks prior to randomization that significantly affects glycemic control, or planned surgery during the study period (excluding outpatient procedures).
• Major cardiovascular or cerebrovascular diseases within 24 weeks prior to screening or before randomization (e.g., myocardial infarction, cerebrovascular accident, unstable angina).

Más betegség

• Known allergic constitution (allergy to 3 or more foods or drugs), allergy to GLP-1 receptor agonists or any component of the study drug, severe allergic disease, or a history of severe drug allergy.
• Diagnosed or suspected type 1 diabetes mellitus, other specific types of diabetes mellitus (excluding gestational diabetes mellitus), or secondary diabetes mellitus.
• Severe chronic complications of diabetes mellitus (e.g., diabetic nephropathy, proliferative diabetic retinopathy, non-proliferative diabetic retinopathy requiring treatment, peripheral vascular disease with amputation, chronic foot ulcer, intermittent claudication, or painful diabetic neuropathy).
• Any unstable or untreated endocrine disease other than type 2 diabetes mellitus (e.g., multiple endocrine neoplasia, acromegaly, Cushing's syndrome).
• History of thyroid disease (except under specific circumstances) or abnormal TSH (TSH >6.0 or <0.4 mIU/L in participants without a history of thyroid disease).
• Medullary thyroid carcinoma, multiple endocrine neoplasia type 2 (MEN2), or a personal or first-degree family history of these conditions.
• Significant active autoimmune abnormalities (e.g., systemic lupus erythematosus, rheumatoid arthritis) requiring systemic glucocorticoids.
• History of sporadic or frequent premature beats or tachycardia, or heart rate >100 beats/min before randomization.
• Uncontrolled hypertension at screening or before randomization (≥160/100 mmHg) or untreated hypertension meeting this criterion.

Laborértékek

• Blood transfusion or blood donation/blood loss ≥400 mL within 12 weeks prior to randomization, or ≥200 mL within 4 weeks prior to screening, or hematologic diseases that may affect HbA1c or pose a safety risk.
• Clinically significant abnormal laboratory findings at screening or before randomization (e.g., ALT or AST ≥3×ULN, eGFR <60 mL/min/1.73 m², anemia, calcitonin ≥35 ng/L).

Egyéb

• Known or pre-randomization ECG abnormalities with significant safety risk (e.g., QTcF >450 ms).

• Male or female participants aged 18 to 75 years (inclusive) at the time of signing the informed consent form.
• Diagnosis of type 2 diabetes mellitus for at least 3 months prior to screening, with inadequate glycemic control despite treatment with lifestyle intervention or a stable dose of metformin monotherapy (≥1500 mg/day, or ≥1000 mg/day if at the maximum tolerated dose) for at least 3 months prior to screening.
• HbA1c ≥7.5% and ≤11.0% at screening and before randomization (central laboratory).
• Fasting plasma glucose ≤13.9 mmol/L at screening and before randomization (central laboratory; may be re-tested once within 1 week if special circumstances apply).
• BMI ≥20.0 kg/m² and ≤40.0 kg/m² at screening.
• Self-reported body weight change of <5% during the at least 12 weeks prior to screening.