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)
Status: Active_not_recruiting
Location: See all (14) locations...
Intervention Type: Other, Biological
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Maximum Age: 75
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Republic of Korea
The Catholic University of KOREA, Bucheon St.Mary's Hostital
Bucheon-si
Yeungnam University Medical Center
Daegu
Daejeon Eul Ji Medical Center, Eul Ji University
Daejeon
Seoul National University Bundang Hospital
Seongnam
Kangbuk Samsung Hospital, Samsung Medical Center
Seoul
KOREA University Anam Hospital
Seoul
KOREA University Asan Hospital
Seoul
Kyung Hee University Hospital at Gangdong
Seoul
Kyung Hee University, Medical Center
Seoul
Nowon Eul Ji Medical Center, Eul Ji University
Seoul
Samsung Medical Center
Seoul
Severance Hostital
Seoul
The Catholic University of KOREA, Seoul St.Mary's Hostital
Seoul
The Catholic University of KOREA, Yeouido St.Mary's Hostital in Korea
Seoul
Time Frame
Start Date:2024-12-05
Completion Date:2025-10-30
Participants
Target number of participants:144
Treatments
Experimental: Cohort A
Cohort A will include two sub-cohorts with different dosing schedules in participants diagnosed with type 2 diabetes.
Experimental: Cohort B1
Cohort B1 will include two sub-cohorts with different dosing schedules in participants with obesity.
Experimental: Cohort B2
Cohort B2 will include two sub-cohorts with different dosing schedules in participants with obesity and type 2 diabetes.
Placebo_comparator: Cohort A (Placebo)
Cohort A will include two sub-cohorts with different dosing schedules in participants diagnosed with type 2 diabetes.
Placebo_comparator: Cohort B1 (Placebo)
Cohort B1 will include two sub-cohorts with different dosing schedules in participants with obesity.
Placebo_comparator: Cohort B2 (Placebo)
Cohort B2 will include two sub-cohorts with different dosing schedules in participants with obesity and type 2 diabetes.