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

ProGen. Co., Ltd.

Status and phase: Active, not recruiting; Phase 2

Conditions: Type 2 Diabetes Mellitus (T2DM); Obesity Type 2 Diabetes Mellitus

Treatments: Other: Placebo; Biological: PG-102

Study type: Interventional

Funder types: Other

Identifiers

NCT06712615

PG-102-P2-01

Details and patient eligibility

About

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.

Enrollment: 144 estimated patients

Sex: All

Ages: 19 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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144 participants in 6 patient groups, including a placebo group

Cohort A

Experimental group

Description:

Cohort A will include two sub-cohorts with different dosing schedules in participants diagnosed with type 2 diabetes.

Treatment:

Biological: PG-102

Cohort B1

Experimental group

Description:

Cohort B1 will include two sub-cohorts with different dosing schedules in participants with obesity.

Treatment:

Biological: PG-102

Cohort B2

Experimental group

Description:

Cohort B2 will include two sub-cohorts with different dosing schedules in participants with obesity and type 2 diabetes.

Treatment:

Biological: PG-102

Cohort A (Placebo)

Placebo Comparator group

Description:

Cohort A will include two sub-cohorts with different dosing schedules in participants diagnosed with type 2 diabetes.

Treatment:

Other: Placebo

Cohort B1 (Placebo)

Placebo Comparator group

Description:

Cohort B1 will include two sub-cohorts with different dosing schedules in participants with obesity.

Treatment:

Other: Placebo

Cohort B2 (Placebo)

Placebo Comparator group

Description:

Cohort B2 will include two sub-cohorts with different dosing schedules in participants with obesity and type 2 diabetes.

Treatment:

Other: Placebo