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.

Study Overview

• Status: Active, not recruiting
• Conditions: Type 2 Diabetes Mellitus (T2DM); Obesity Type 2 Diabetes Mellitus
• Intervention / Treatment: Biological: PG-102; Other: Placebo

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 Type: Interventional
• Enrollment (Estimated): 144
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Bucheon, Korea, Republic of
    • The Catholic University of KOREA, Bucheon St.Mary's Hostital
  • Daegu, Korea, Republic of
    • Yeungnam University Medical Center
  • Daejeon, Korea, Republic of
    • Daejeon Eul Ji Medical Center, Eul Ji University
  • Seongnam, Korea, Republic of
    • Seoul National University Bundang Hospital
  • Seoul, Korea, Republic of
    • Samsung Medical Center
  • Seoul, Korea, Republic of
    • Kyung Hee University Hospital at Gangdong
  • Seoul, Korea, Republic of
    • Korea University Anam Hospital
  • Seoul, Korea, Republic of
    • Kangbuk Samsung Hospital, Samsung Medical Center
  • 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
    • Nowon Eul Ji Medical Center, Eul Ji University
  • Seoul, Korea, Republic of
    • Severance Hostital
  • Seoul, Korea, Republic of
    • The Catholic University of KOREA, Yeouido St.Mary's Hostital in Korea

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort A; Cohort A will include two sub-cohorts with different dosing schedules in participants diagnosed with type 2 diabetes.	Biological: PG-102; Participants will receive PG-102 by subcutaneous (SC) injection.; Other Names: MG12
Experimental: Cohort B1; Cohort B1 will include two sub-cohorts with different dosing schedules in participants with obesity.	Biological: PG-102; Participants will receive PG-102 by subcutaneous (SC) injection.; Other Names: MG12
Experimental: Cohort B2; Cohort B2 will include two sub-cohorts with different dosing schedules in participants with obesity and type 2 diabetes.	Biological: PG-102; Participants will receive PG-102 by subcutaneous (SC) injection.; Other Names: MG12
Placebo Comparator: Cohort A (Placebo); Cohort A will include two sub-cohorts with different dosing schedules in participants diagnosed with type 2 diabetes.	Other: Placebo; Participants will receive placebo by SC injection
Placebo Comparator: Cohort B1 (Placebo); Cohort B1 will include two sub-cohorts with different dosing schedules in participants with obesity.	Other: Placebo; Participants will receive placebo by SC injection
Placebo Comparator: Cohort B2 (Placebo); Cohort B2 will include two sub-cohorts with different dosing schedules in participants with obesity and type 2 diabetes.	Other: Placebo; Participants will receive placebo by SC injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in Glycated Hemoglobin (HbA1c) in Cohort A	Baseline at weeks 14
Percent Change from Baseline in Body Weight in Cohort B1 and B2	Baseline at weeks 14

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of Treatment-emergent adverse events (TEAEs) in Cohort A and Cohort B1, B2	Baseline to weeks 20
Change from Baseline in HbA1c in Cohort A and B2	Baseline at weeks 4, 8, 12, 14, 16, and 20
Percent Change from Baseline in fasting plasma glucose (FPG) in Cohort A and B2	Baseline at weeks 4, 8, 12, 14, 16, and 20
Absolute Change from Baseline in fasting plasma glucose in Cohort A and B2	Baseline, Week 4, 8, 12, 14, 16, and 20 weeks
Percent Change from Baseline in Body Weight in Cohort B1 and B2	Baseline at weeks 4, 8, 12, 16, and 20
Absolute Change from Baseline in Body Weight in Cohort B1 and B2	Baseline at weeks 4, 8, 12, 14, 16, and 20

Collaborators and Investigators

• Sponsor: ProGen. Co., Ltd.
• Investigators: Principal Investigator: Sin Gon Kim, MD, KOREA University Anam Hospital, Seoul, South Korea; Principal Investigator: Nan Hee Kim, MD, KOREA University Asan Hospital in Korea; Principal Investigator: Seung-Hwan Lee, MD, The Catholic University of KOREA, Seoul St.Mary's Hostital in Korea; Principal Investigator: Yong-Ho Lee, MD, Severance Hostital in Korea; Principal Investigator: Hyuk-Sang Kwon, MD, The Catholic University of KOREA, Yeouido St.Mary's Hostital in Korea; Principal Investigator: Jang Won Son, MD, The Catholic University of KOREA, Bucheon St.Mary's Hostital in Korea; Principal Investigator: Sang Youl Rhee, MD, Kyung Hee University, Medical Center in Korea; Principal Investigator: In Kyung Jeong, MD, Kyung Hee University Hospital at Gangdong in Korea; Principal Investigator: Jae-Heon Kang, MD, Kangbuk Samsung Hospital, Samsung Medical Center in Korea; Principal Investigator: Jae Hyeon Kim, MD, Samsung Medical Center in Korea; Principal Investigator: Kyung Wan Min, MD, Nowon Eul Ji Medical Center, Eul Ji University in Korea; Principal Investigator: Jun Hwa Hong, MD, Daejeon Eul Ji Medical Center, Eul Ji University in Korea; Principal Investigator: Kyu Chang Won, MD, Yeungnam University Medical Center in Korea; Principal Investigator: Soo Lim, MD, Seoul National University Bundang Hospital in Korea

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2024
• Primary Completion (Estimated): October 30, 2025
• Study Completion (Estimated): October 30, 2025

Study Registration Dates

• First Submitted: November 26, 2024
• First Submitted That Met QC Criteria: November 26, 2024
• First Posted (Actual): December 2, 2024

Study Record Updates

• Last Update Posted (Actual): July 11, 2025
• Last Update Submitted That Met QC Criteria: July 8, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Nutrition Disorders; Metabolic Diseases; Overnutrition; Body Weight; Glucose Metabolism Disorders; Overweight; Obesity; Diabetes Mellitus, Type 2; Diabetes Mellitus
• Other Study ID Numbers: PG-102-P2-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No