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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A | Experimental | Cohort A will include two sub-cohorts with different dosing schedules in participants diagnosed with type 2 diabetes. |
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| Cohort B1 | Experimental | Cohort B1 will include two sub-cohorts with different dosing schedules in participants with obesity. |
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| Cohort B2 | Experimental | Cohort B2 will include two sub-cohorts with different dosing schedules in participants with obesity and type 2 diabetes. |
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| Cohort A (Placebo) | Placebo Comparator | Cohort A will include two sub-cohorts with different dosing schedules in participants diagnosed with type 2 diabetes. |
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| Cohort B1 (Placebo) | Placebo Comparator | Cohort B1 will include two sub-cohorts with different dosing schedules in participants with obesity. |
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| Cohort B2 (Placebo) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PG-102 | Biological |
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| Measure | Description | 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 |
| Measure | Description | 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 |
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Inclusion Criteria:
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%.
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:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Catholic University of KOREA, Bucheon St.Mary's Hostital | Bucheon-si | South Korea | ||||
| Yeungnam University Medical Center |
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Double (Participant, Investigator)
Cohort B2 will include two sub-cohorts with different dosing schedules in participants with obesity and type 2 diabetes. |
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| Placebo | Other | Participants will receive placebo by SC injection |
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| 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 |
| 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 |
| Daegu |
| South Korea |
| Daejeon Eul Ji Medical Center, Eul Ji University | Daejeon | South Korea |
| Seoul National University Bundang Hospital | Seongnam | South Korea |
| Kangbuk Samsung Hospital, Samsung Medical Center | Seoul | South Korea |
| KOREA University Anam Hospital | Seoul | South Korea |
| KOREA University Asan Hospital | Seoul | South Korea |
| Kyung Hee University Hospital at Gangdong | Seoul | South Korea |
| Kyung Hee University, Medical Center | Seoul | South Korea |
| Nowon Eul Ji Medical Center, Eul Ji University | Seoul | South Korea |
| Samsung Medical Center | Seoul | South Korea |
| Severance Hostital | Seoul | South Korea |
| The Catholic University of KOREA, Seoul St.Mary's Hostital | Seoul | South Korea |
| The Catholic University of KOREA, Yeouido St.Mary's Hostital in Korea | Seoul | South Korea |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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