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

Phase 2

Recruiting

• Conditions: Type 2 Diabetes Mellitus (T2DM); Obesity Type 2 Diabetes Mellitus
• Interventions: Biological: PG-102; Other: Placebo

• Registration Number: NCT06712615
• Lead Sponsor: ProGen. Co., Ltd.

Brief Summary

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.

Detailed 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.

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-26
• Study First Submitted QC: 2024-11-26
• Study First Posted: 2024-12-02
• Study Start: 2024-12-05
• Last Update Submitted: 2024-12-26
• Last Update Posted: 2024-12-27
• Primary Completion: 2025-03-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 144

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort B11 (OB Group/PG-102)	PG-102	PG-102(MG12) Dose 1, 2 and 3 (N=16), Placebo (N=8) Subcutaneous injection
Cohort B21 (OB with T2DM/PG-102)	PG-102	PG-102(MG12) Dose 1, 2 and 3 (N=16) Subcutaneous injection
Cohort B22 (OB with T2DM/PG-102)	PG-102	PG-102(MG12) Dose 1, 2 and 3 (N=16) Subcutaneous injection
Cohort A1 (T2DM/PG-102)	PG-102	PG-102(MG12) Dose 1, 2 and 3 (N=16), Placebo (N=8) Subcutaneous injection
Cohort A2 (T2DM/PG-102)	PG-102	PG-102(MG12) Dose 1, 2 and 3 (N=16), Placebo (N=8) Subcutaneous injection
Cohort B12 (OB Group/PG-102)	PG-102	PG-102(MG12) Dose 1, 2 and 3 (N=16)Subcutaneous injection
Cohort A1 (T2DM/PL)	Placebo	PG-102(MG12) Dose 1, 2 and 3 (N=16), Placebo (N=8) Subcutaneous injection
Cohort A2 (T2DM/PL)	Placebo	PG-102(MG12) Dose 1, 2 and 3 (N=16), Placebo (N=8) Subcutaneous injection
Cohort B11 (OB Group/PL)	Placebo	PG-102(MG12) Dose 1, 2 and 3 (N=16), Placebo (N=8) Subcutaneous injection
Cohort B12 (OB Group/PL)	Placebo	PG-102(MG12) Dose 1, 2 and 3 (N=16), Placebo (N=8) Subcutaneous injection
Cohort B21 (OB with T2DM/PL)	Placebo	PG-102(MG12) Dose 1, 2 and 3 (N=16), Placebo (N=8) Subcutaneous injection
Cohort B22 (OB with T2DM/PL)	Placebo	PG-102(MG12) Dose 1, 2 and 3 (N=16), Placebo (N=8) Subcutaneous injection

Primary Outcome Measures

Name	Time	Method
Change in Glycated Hemoglobin (HbA1c) in part A	Baseline at weeks 14	Change in Glycated Hemoglobin (HbA1c) from baseline at Week 14, measured as the absolute change in HbA1c (%) for each participant in part A
Change in Glycated Hemoglobin (HbA1c) in Part B	Baseline at weeks 14	Change in Glycated Hemoglobin (HbA1c) from baseline at Week 14, measured as the absolute change in HbA1c (%) for each participant in part B

Secondary Outcome Measures

Name	Time	Method
Percent Change in Fasting Plasma Glucose (FPG) from Baseline (Cohort B2)	Baseline at weeks 4, 8, 12, 14, 16, and 20	Assessed as the percentage change in FPG levels for each participant within Cohort B2.
Evaluation of treatment-emergent adverse events (TEAEs) in Part A	Baseline to weeks 20	Number of participants with treatment-emergent adverse events (TEAEs) reported after administration of PG-102
Percent Change in Fasting Plasma Glucose (FPG) from Baseline	Baseline at weeks 4, 8, 12, 14, 16, and 20	Assessed as the percentage change in each participant's FPG levels in Part A
Evaluation of treatment-emergent adverse events (TEAEs) in Part B.	Baseline to weeks 20	Number of participants with treatment-emergent adverse events (TEAEs) reported after administration of PG-102
Percent Change in Body Weight from Baseline	Baseline at weeks 4, 8, 12, 16, and 20	Measured as the percentage change in body weight for each participant in Part B
Absolute Change in Body Weight from Baseline	Baseline at weeks 4, 8, 12, 14, 16, and 20	Measured as the absolute change in body weight (kg) for each participant.
Change in Glycated Hemoglobin (HbA1c) from Baseline (Cohort B2)	Baseline at weeks 4, 8, 12, 14, 16, and 20	Measured as the percentage change in HbA1c levels for each participant within Cohort B2.
Absolute Change in Fasting Plasma Glucose (FPG) from Baseline (Cohort B2)	Baseline at weeks 4, 8, 12, 14, 16, and 20	Measured as the absolute change in FPG levels (mg/dL) for each participant within Cohort B2.

Trial Locations

Locations (6)

Kangbuk Samsung Hospital, Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of

KOREA University Anam Hospital; 🇰🇷 Seoul, Korea, Republic of

KOREA University Asan Hospital; 🇰🇷 Seoul, Korea, Republic of

Kyung Hee University, Medical Center; 🇰🇷 Seoul, Korea, Republic of

The Catholic University of KOREA, Seoul St.Mary's Hostital; 🇰🇷 Seoul, Korea, Republic of

Seoul National University Bundang Hospital; 🇰🇷 Sungnam, Korea, Republic of