Phase II Study of PG-102(MG12) Compared With Placebo in Obesity and Type 2 Diabetes

Korábbi kezelés

• Inability to administer the drug in the abdomen.

Más betegség

• Known hypersensitivity to study drugs or their components.
• History of severe gastrointestinal disorders, recent obesity-related surgeries, or conditions affecting gastric emptying.
• Uncontrolled severe hypertension, hypertriglyceridemia, or severe cardiovascular disease.
• History of acute pancreatitis, recent cancer, or endocrine disorders causing obesity.
• Substance abuse or significant psychiatric disorders within the last 2 years.

Laborértékek

• Abnormal lab results, including eGFR < 60 mL/min/1.73 m², AST/ALT > 3x ULN, or abnormal ECG.

Egyéb

• Participation in another clinical trial within 90 days.
• Pregnant, breastfeeding, or unwilling to use contraception during the study.

• Adults aged 19 to 75 years who provide informed consent.
  • [Part A: Type 2 Diabetes Mellitus (T2DM) Specific Criteria]
• Diagnosed with type 2 diabetes for at least 6 months, with HbA1c between 7.0% and 10.0%, despite adherence to diet and exercise therapy according to diabetes treatment guidelines.
• Stable on metformin monotherapy or metformin in combination with one oral hypoglycemic agent for at least 90 days.
• BMI between 18.5 kg/m² and 30.0 kg/m², with a minimum weight of 55 kg for men and 50 kg for women.
  • [Part B: Obesity (OB) Specific Criteria]
• Failed at least one attempt at weight loss through diet and exercise.
• Cohort B1: BMI ≥ 30 kg/m²
• Cohort B2: BMI ≥ 27 kg/m² 8-1. Cohort B2: Diagnosed with type 2 diabetes for at least 6 months, with HbA1c between 7.0% and 10.0%.
  • 8-2. Cohort B2: Received treatment with diet and exercise alone, OR stable on approved oral antidiabetic monotherapy or combination therapy for at least 90 days prior to screening.