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

A Phase II Randomized, Double-blind, Multi-center Study to Investigate the Efficacy and Safety of PG-102(MG12) Compared With Placebo in Subjects With Obesity and in Subjects With Type 2 Diabetes Mellitus (T2DM)

This is a Phase 2, therapeutic exploratory study designed to evaluate the safety and efficacy of PG-102 compared with placebo. Part A includes Cohort A, comprising participants with type 2 diabetes mellitus (T2DM). Part B includes two cohorts: Cohort B1, enrolling participants with obesity, and Cohort B2, enrolling participants with both obesity and T2DM.

Inclusion Criteria:

1. Adults aged 19 to 75 years who provide informed consent.

   [Part A: Type 2 Diabetes Mellitus (T2DM) Specific Criteria]

2. 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.

3. Stable on metformin monotherapy or metformin in combination with one oral hypoglycemic agent for at least 90 days.

4. 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]

5. Failed at least one attempt at weight loss through diet and exercise.

6. Cohort B1: BMI ≥ 30 kg/m²

7. 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.

Exclusion Criteria:

1. Participation in another clinical trial within 90 days.
2. Known hypersensitivity to study drugs or their components.
3. Inability to administer the drug in the abdomen.
4. History of severe gastrointestinal disorders, recent obesity-related surgeries, or conditions affecting gastric emptying.
5. Uncontrolled severe hypertension, hypertriglyceridemia, or severe cardiovascular disease.
6. History of acute pancreatitis, recent cancer, or endocrine disorders causing obesity.
7. Abnormal lab results, including eGFR < 60 mL/min/1.73 m², AST/ALT > 3x ULN, or abnormal ECG.
8. Substance abuse or significant psychiatric disorders within the last 2 years.
9. Pregnant, breastfeeding, or unwilling to use contraception during the study.