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

ProGen. Co., Ltd.

Status and phase: Enrolling; 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 phase 2 clinical trial aims to evaluate the safety and efficacy of PG-102 (MG12) in patients with type 2 diabetes and obesity. The study is a randomized, double-blind, placebo-controlled, multi-center trial. Participants will be randomly assigned to receive either PG-102 or a placebo over a 12-week treatment period. The primary goal is to investigate the therapeutic potential of PG-102 in improving clinical outcomes for type 2 diabetes and obesity, while closely monitoring the safety profile of the treatment.

Full description

The study will be conducted in two parts, A and B, with a total of six cohorts. Part A will involve two cohorts comprising patients with type 2 diabetes, while Part B will include four cohorts of patients with obesity.

Part A (T2DM): In Part A, subjects with type 2 diabetes will receive multiple doses of the study drug over a 12-week period, with varying dosing schedules across the two cohorts, to evaluate the safety and efficacy of PG-102 (MG12).

Part B (OB): In Part B, subjects with obesity will receive multiple doses of the study drug over a 12-week period, with varying dosing schedules across the four cohorts to evaluate the safety and efficacy of PG-102 (MG12) in this subgroup. Cohort B2 will include subjects who are both obese and have type 2 diabetes.

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 12 patient groups, including a placebo group

Cohort A1 (T2DM/PG-102)

Experimental group

Description:

PG-102(MG12) Dose 1, 2 and 3 (N=16), Placebo (N=8) Subcutaneous injection

Treatment:

Biological: PG-102

Cohort A2 (T2DM/PG-102)

Experimental group

Description:

PG-102(MG12) Dose 1, 2 and 3 (N=16), Placebo (N=8) Subcutaneous injection

Treatment:

Biological: PG-102

Cohort B11 (OB Group/PG-102)

Experimental group

Description:

PG-102(MG12) Dose 1, 2 and 3 (N=16), Placebo (N=8) Subcutaneous injection

Treatment:

Biological: PG-102

Cohort B12 (OB Group/PG-102)

Experimental group

Description:

PG-102(MG12) Dose 1, 2 and 3 (N=16)Subcutaneous injection

Treatment:

Biological: PG-102

Cohort B21 (OB with T2DM/PG-102)

Experimental group

Description:

PG-102(MG12) Dose 1, 2 and 3 (N=16) Subcutaneous injection

Treatment:

Biological: PG-102

Cohort B22 (OB with T2DM/PG-102)

Experimental group

Description:

PG-102(MG12) Dose 1, 2 and 3 (N=16) Subcutaneous injection

Treatment:

Biological: PG-102

Cohort A1 (T2DM/PL)

Placebo Comparator group

Description:

PG-102(MG12) Dose 1, 2 and 3 (N=16), Placebo (N=8) Subcutaneous injection

Treatment:

Other: Placebo

Cohort A2 (T2DM/PL)

Placebo Comparator group

Description:

PG-102(MG12) Dose 1, 2 and 3 (N=16), Placebo (N=8) Subcutaneous injection

Treatment:

Other: Placebo

Cohort B11 (OB Group/PL)

Placebo Comparator group

Description:

PG-102(MG12) Dose 1, 2 and 3 (N=16), Placebo (N=8) Subcutaneous injection

Treatment:

Other: Placebo

Cohort B12 (OB Group/PL)

Placebo Comparator group

Description:

PG-102(MG12) Dose 1, 2 and 3 (N=16), Placebo (N=8) Subcutaneous injection

Treatment:

Other: Placebo

Cohort B21 (OB with T2DM/PL)

Placebo Comparator group

Description:

PG-102(MG12) Dose 1, 2 and 3 (N=16), Placebo (N=8) Subcutaneous injection

Treatment:

Other: Placebo

Cohort B22 (OB with T2DM/PL)

Placebo Comparator group

Description:

PG-102(MG12) Dose 1, 2 and 3 (N=16), Placebo (N=8) Subcutaneous injection

Treatment:

Other: Placebo