Study to Evaluate HM15275 in Subjects With Type 2 Diabetes Mellitus

Korábbi kezelés

• Participation in another investigational study within 30 days or within 5 half-lives of the investigational product, whichever is longer; for GLP-1 receptor agonist-related or weight loss studies, participation within 3 months prior to screening

Más betegség

• History of diabetic ketoacidosis or severe hypoglycemia within 6 months
• Clinically significant cardiovascular disease (e.g., NYHA class III/IV heart failure, recent myocardial infarction, stroke, or revascularization within 3 months)
• History of pancreatitis or factors increasing the risk of pancreatitis
• Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2

Laborértékek

• Type 1 diabetes mellitus or use of glucose-lowering medications other than metformin within 3 months prior to screening
• Poor glycemic control (fasting plasma glucose >270 mg/dL)
• Clinically significant liver disease, renal impairment (eGFR <60 mL/min/1.73 m²), or abnormal laboratory findings at screening

• Participant's age at the time of signing the informed consent:
  • United States: 18 to 75 years (inclusive)
• Diagnosed with type 2 diabetes mellitus (T2DM) with HbA1c ≥7.0% and ≤10.0% at screening
• Treated with diet and exercise alone or on a stable dose of metformin (≥1000 mg/day) for at least 3 months prior to screening
• BMI ≥25 kg/m² and ≤50 kg/m²
• Body weight change <5% over the past 3 months prior to screening
• Capable of giving signed informed consent and willing to comply with all protocol procedures