Obesity Type 2 Diabetes Mellitus, Type 2 Diabetes Mellitus (T2DM)
Conditions
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.
Interventions
BIOLOGICALPG-102
* Participants will receive PG-102 by subcutaneous (SC) injection. * Other Names: MG12
OTHERPlacebo
Participants will receive placebo by SC injection
Sponsors
ProGen. Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Double (Participant, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent Change from Baseline in Body Weight in Cohort B1 and B2 | Baseline at weeks 14 |
| Change in Glycated Hemoglobin (HbA1c) in Cohort A | Baseline at weeks 14 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Incidence of Treatment-emergent adverse events (TEAEs) in Cohort A and Cohort B1, B2 | Baseline to weeks 20 |
| Absolute Change from Baseline in Body Weight in Cohort B1 and B2 | Baseline at weeks 4, 8, 12, 14, 16, and 20 |
| Percent Change from Baseline in Body Weight in Cohort B1 and B2 | Baseline at weeks 4, 8, 12, 16, and 20 |
| Change from Baseline in HbA1c in Cohort A and B2 | Baseline at weeks 4, 8, 12, 14, 16, and 20 |
Countries
South Korea
Outcome results
None listed