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

Phase 2

Active, not 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 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.

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

• Study First Submitted: 2024-11-26
• Study First Submitted QC: 2024-11-26
• Study First Posted: 2024-12-02
• Study Start: 2024-12-05
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-08
• Last Update Posted: 2025-07-11
• Primary Completion: 2025-10-30
• Study Completion: 2025-10-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_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 A	PG-102	Cohort A will include two sub-cohorts with different dosing schedules in participants diagnosed with type 2 diabetes.
Cohort B1	PG-102	Cohort B1 will include two sub-cohorts with different dosing schedules in participants with obesity.
Cohort B2	PG-102	Cohort B2 will include two sub-cohorts with different dosing schedules in participants with obesity and type 2 diabetes.
Cohort A (Placebo)	Placebo	Cohort A will include two sub-cohorts with different dosing schedules in participants diagnosed with type 2 diabetes.
Cohort B1 (Placebo)	Placebo	Cohort B1 will include two sub-cohorts with different dosing schedules in participants with obesity.
Cohort B2 (Placebo)	Placebo	Cohort B2 will include two sub-cohorts with different dosing schedules in participants with obesity and type 2 diabetes.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (14)

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

Yeungnam University Medical Center; 🇰🇷 Daegu, Korea, Republic of

Daejeon Eul Ji Medical Center, Eul Ji University; 🇰🇷 Daejeon, Korea, Republic of

Kyung Hee University Hospital at Gangdong; 🇰🇷 Seoul, Korea, Republic of

Nowon Eul Ji Medical Center, Eul Ji University; 🇰🇷 Seoul, Korea, Republic of

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

Severance Hostital; 🇰🇷 Seoul, Korea, Republic of

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

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

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

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