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

NCT06712615 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: PG-102-P2-01
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 14

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• 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

Study Arms (6)

Cohort A

EXPERIMENTAL

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

Biological: PG-102

Cohort B1

EXPERIMENTAL

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

Biological: PG-102

Cohort B2

EXPERIMENTAL

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

Biological: PG-102

Cohort A (Placebo)

PLACEBO COMPARATOR

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

Other: Placebo

Cohort B1 (Placebo)

PLACEBO COMPARATOR

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

Other: Placebo

Cohort B2 (Placebo)

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

PG-102 BIOLOGICAL

* Participants will receive PG-102 by subcutaneous (SC) injection. * Other Names: MG12

Cohort A; Cohort B1; Cohort B2

Placebo OTHER

Participants will receive placebo by SC injection

Cohort A (Placebo); Cohort B1 (Placebo); Cohort B2 (Placebo)

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 19 to 75 years who provide informed consent.
• \[Part A: Type 2 Diabetes Mellitus (T2DM) Specific Criteria\]
• 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.
• Stable on metformin monotherapy or metformin in combination with one oral hypoglycemic agent for at least 90 days.
• 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.
• \[Part B: Obesity (OB) Specific Criteria\]
• Failed at least one attempt at weight loss through diet and exercise.
• Cohort B1: BMI ≥ 30 kg/m²
• 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%.
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• ProGen. Co., Ltd.: lead

Study Sites (14)

The Catholic University of KOREA, Bucheon St.Mary's Hostital

Bucheon-si, South Korea

Location

Yeungnam University Medical Center

Daegu, South Korea

Location

Daejeon Eul Ji Medical Center, Eul Ji University

Daejeon, South Korea

Location

Seoul National University Bundang Hospital

Seongnam, South Korea

Location

Kangbuk Samsung Hospital, Samsung Medical Center

Seoul, South Korea

Location

KOREA University Anam Hospital

Seoul, South Korea

Location

KOREA University Asan Hospital

Seoul, South Korea

Location

Kyung Hee University Hospital at Gangdong

Seoul, South Korea

Location

Kyung Hee University, Medical Center

Seoul, South Korea

Location

Nowon Eul Ji Medical Center, Eul Ji University

Seoul, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Severance Hostital

Seoul, South Korea

Location

The Catholic University of KOREA, Seoul St.Mary's Hostital

Seoul, South Korea

Location

The Catholic University of KOREA, Yeouido St.Mary's Hostital in Korea

Seoul, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• 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

• Soo Lim, MD

  Seoul National University Bundang 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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double (Participant, Investigator)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: December 2, 2024
• Study Start: December 5, 2024
• Primary Completion: October 30, 2025
• Study Completion: October 30, 2025
• Last Updated: July 11, 2025

Record last verified: 2025-07

Locations

KR (14)