None listed
Conditions
Interventions
Drug : Part A (T2DM): In Part A, subjects with Type 2 Diabetes Mellitus (T2DM) will receive multiple subcutaneous doses of PG-102 over a 12-week treatment period. Dosing schedules will vary across the
Sponsors
ProGen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Common: 1) Subjects who have voluntarily agreed to participate, understand the trial, and have provided written informed consent. 2) Age between 19 and 75 years, inclusive. Part A only (Type 2 diabetes mellitus): 3) Diagnosed with Type 2 Diabetes Mellitus at least 6 months prior to screening, with HbA1c of 7.0-10.0% at screening despite diet and exercise control. 4) Stable on metformin monotherapy or metformin in combination with one oral hypoglycemic agent for at least 90 days. 5) Body weight =55 kg for males, =50 kg for females, with a BMI(Body Mass Index) of 18.5-30.0 kg/m² at screening. Part B only (Obesity): 6) Failed at least one diet and exercise program for weight loss. 7) [Cohort B1] Body Mass Index (BMI) = 30 kg/m² [Cohort B2] Body Mass Index (BMI) = 27 kg/m² 8) Cohort B2: ? Diagnosed with Type 2 Diabetes Mellitus at least 6 months prior to screening, with HbA1c of 7.0-10.0% at screening. ? Only on a diet and exercise program, or on stable, approved doses of oral antidiabetic drugs, either as monotherapy or in combination, for at least 90 days prior to screening.
Exclusion criteria
Exclusion criteria: Common: 1) Participation in another clinical trial within 90 days prior to screening. 2) History of significant hypersensitivity to investigational products or other drugs. 3) Restrictions on abdominal administration of the investigational product. 4) The following history or signs: • History of severe gastrointestinal diseases or surgeries affecting gastric emptying or absorption. • Uncontrolled severe hypertension (Systolic blood pressure > 180 mmgHg or Diastolic blood pressure > 110 mmgHg) • Uncontrolled severe hypertriglyceridemia (Triglyceride > 500 mg/dL). • Severe cardiovascular diseases. - New York Heart Association (NYHA) Class III and IV heart failure, myocardial infarction, unstable angina, clinically significant coronary artery disease (e.g., Canadian Cardiovascular Society (CCS) Class III and IV angina), coronary artery bypass grafting, emergency percutaneous coronary intervention (diagnostic coronary angiography and selective coronary interventions are permitted), transient ischemic attack, cerebrovascular accident (stroke), or compensated congestive heart failure. (provided that the event occurred more than 6 months ago and the patient is currently in a cured or stable condition, they are eligible for enrollment). • History of acute pancreatitis or pancreatic surgery. • History of malignancies within the past 5 years (except specific skin cancers and in situ carcinomas). • History of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2). • Positive test results for HBsAg, HCV antibodies, or HIV antibodies/antigen. • History of depressive disorder or severe mental illness (e.g., schizophrenia, bipolar disorder, etc.) within 2 years prior to screening. 5) Subject with the following drug administration history: • Systemic corticosteroid use within 90 days prior to screening (excluding short-term treatment (= 10 days)) • Glucagon-like peptide-1 (GLP-1) receptor agonist use within 90 days prior to screening. • Use of approved weight control medications or hormone treatments within 90 days prior to screening • History of alcohol or drug abuse within 2 years prior to screening 6) Screening results indicating renal insufficiency or abnormal liver function. • eGFR (CKD-EPI) 3 times the upper limit of normal • Serum total bilirubin > 2 times the upper limit of normal • Abnormal findings on the 12-lead ECG during screening, and the investigator determines the subject is unsuitable for participation in the clinical trial 7) Women or men of childbearing potential not agreeing to use dual contraception or abstinence. 8) Currently pregnant, breastfeeding, or planning pregnancy during the trial. 9) Other conditions making the subject unsuitable for the trial. Part A – Cohort A1, A2, Part B – Cohort B2 (Type 2 Diabetes Mellitus): 10) Patients with types of diabetes other than type 2 diabetes (e.g., type 1 diabetes, secondary diabetes, or congenital renal diabetes). 11) More than one episode of ketoacidosis or hyperosmolar state requiring hospitalization within 6 months prior to screening. 12) Patients with the following hypoglycemic episodes within 6 months prior to screening: • More than one episode of severe hypoglycemia, defined as neuroglycopenic symptoms requiring assistance from another person for recovery or any history of unawareness of hypoglycemia or impaired awareness of hypoglycemic symptoms 13) Patients with severe diabetic complications, such as diabetic r
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| [Part A] Change in Glycated Hemoglobin (HbA1c) from baseline at Week 14, measured as the absolute change in HbA1c (%) for each participant in Part A.;[Part B] Percent change in body weight from baseline at Week 14, measured as the percentage change in body weight for each participant in Part B. | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of treatment-emergent adverse events (TEAEs) in Part A and Part B. Number of participants with treatment-emergent adverse events (TEAEs) reported after administration of PG-102;[Part A] Change in Glycated Hemoglobin (HbA1c) from Baseline: Measured as the percentage change in HbA1c levels for each participant in Part A;[Part A] Percent Change in Fasting Plasma Glucose (FPG) from Baseline: Assessed as the percentage change in each participant's FPG levels in Part A.;[Part A] Absolute Change in Fasting Plasma Glucose (FPG) from Baseline: Measured as the absolute change in FPG levels (mg/dL) for each participant in Part A.;[Part B] Percent Change in Body Weight from Baseline: Measured as the percentage change in body weight for each participant in Part B.;[Part B] Absolute Change in Body Weight from Baseline: Measured as the absolute change in body weight (kg) for each participant..;[Cohort B2] Change in Glycated Hemoglobin (HbA1c) from Baseline: Measured as the percentage change in HbA1c levels for each participant within Cohort B2.;[Cohort B2] Percent Change in Fasting Plasma Glucose (FPG) from Baseline: Assessed as the percentage change in FPG levels for each participant within Cohort B2.;[Cohort B2] Absolute Change in Fasting Plasma Glucose (FPG) from Baseline: Measured as the absolute change in FPG levels (mg/dL) for each participant within Cohort B2. | — |
Countries
Korea, Republic of
Contacts
Public ContactSin Gon Kim
Korea University Anam Hospital
Outcome results
None listed