Evaluating PG-102 for obesity and type 2 diabetes
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)
This study is testing a new medication called PG-102 to see if it can help people with obesity and type 2 diabetes improve their health over 12 weeks.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 144 (estimated) |
| Ages | 19 Years to 75 Years |
| Sex | All |
| Sponsor | ProGen. Co., Ltd. Academic / other |
| Locations | 6 sites (Seoul and 5 other locations) |
| Trial ID | NCT06712615 on ClinicalTrials.gov |
What this trial studies
This phase 2 clinical trial assesses the safety and efficacy of PG-102 (MG12) in patients with type 2 diabetes and obesity through a randomized, double-blind, placebo-controlled design. Participants will be divided into two parts: one focusing on individuals with type 2 diabetes and the other on those with obesity, with a total of six cohorts. Each cohort will receive multiple doses of PG-102 or a placebo over a 12-week period, aiming to improve clinical outcomes while monitoring safety. The study will evaluate varying dosing schedules to determine the optimal therapeutic approach.
Who should consider this trial
Good fit: Ideal candidates include adults aged 19 to 75 with type 2 diabetes or obesity who have not achieved weight loss through diet and exercise alone.
Not a fit: Patients who are not diagnosed with type 2 diabetes or obesity, or those who have not adhered to previous treatment regimens, may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for managing obesity and type 2 diabetes.
How similar studies have performed: Other studies have shown promise in similar approaches, but the specific use of PG-102 in this context is novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Seoul and 5 other locations
- Kangbuk Samsung Hospital, Samsung Medical Center — Seoul, Korea, Republic of (Recruiting)
- KOREA University Anam Hospital — Seoul, Korea, Republic of (Recruiting)
- KOREA University Asan Hospital — Seoul, Korea, Republic of (Recruiting)
- Kyung Hee University, Medical Center — Seoul, Korea, Republic of (Recruiting)
- The Catholic University of KOREA, Seoul St.Mary's Hostital — Seoul, Korea, Republic of (Recruiting)
- Seoul National University Bundang Hospital — Sungnam, Korea, Republic of (Recruiting)
Study contacts
- Principal investigator: Sin Gon Kim, MD — KOREA University Anam Hospital, Seoul, South Korea
- Study coordinator: Kyunghwa Son, Ph.D
- Email: khson@progen.co.kr
- Phone: +82-2-6098-2818
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.