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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
144
The Catholic University of KOREA, Bucheon St.Mary's Hostital
Bucheon-si, South Korea
Yeungnam University Medical Center
Daegu, South Korea
Daejeon Eul Ji Medical Center, Eul Ji University
Daejeon, South Korea
Change in Glycated Hemoglobin (HbA1c) in Cohort A
Time frame: Baseline at weeks 14
Percent Change from Baseline in Body Weight in Cohort B1 and B2
Time frame: Baseline at weeks 14
Incidence of Treatment-emergent adverse events (TEAEs) in Cohort A and Cohort B1, B2
Time frame: Baseline to weeks 20
Change from Baseline in HbA1c in Cohort A and B2
Time frame: Baseline at weeks 4, 8, 12, 14, 16, and 20
Percent Change from Baseline in fasting plasma glucose (FPG) in Cohort A and B2
Time frame: Baseline at weeks 4, 8, 12, 14, 16, and 20
Absolute Change from Baseline in fasting plasma glucose in Cohort A and B2
Time frame: Baseline, Week 4, 8, 12, 14, 16, and 20 weeks
Percent Change from Baseline in Body Weight in Cohort B1 and B2
Time frame: Baseline at weeks 4, 8, 12, 16, and 20
Absolute Change from Baseline in Body Weight in Cohort B1 and B2
Time frame: Baseline at weeks 4, 8, 12, 14, 16, and 20
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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
...and 4 more locations