Phase II Study of PG-102(MG12) Compared with Placebo in Obesity and Type 2 Diabetes

Launched by PROGEN. CO., LTD. · Nov 26, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called PG-102 (MG12) to see if it can help people with type 2 diabetes and obesity. The goal is to find out if this treatment is safe and effective over a 12-week period. Participants in the trial will be randomly assigned to receive either PG-102 or a placebo (a harmless pill with no active ingredients). The trial is currently recruiting adults aged 19 to 75 who have been diagnosed with type 2 diabetes for at least six months and are having trouble managing their condition with diet and exercise alone.

To be eligible, participants should have a body mass index (BMI) between 18.5 and 30, or a higher BMI if they have struggled with weight loss previously. Those already taking certain diabetes medications may also qualify. Throughout the study, participants will be closely monitored for any side effects and changes in their diabetes and weight. This trial offers a chance to help improve treatment options for others facing similar health challenges.

Gender

ALL

Eligibility criteria

• 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.