A Study to Investigate the Safety, Tolerability, and Pharmacokinetics and Pharmacodynamics Following Subcutaneous Injections of PG-102 (MG12) in Healthy Adult and Obesity Participants.

Launched by PROGEN. CO., LTD. · Mar 7, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called PG-102(MG12) to understand how safe it is and how it works in the body. It involves healthy adults who are overweight, and the study aims to learn more about how well the treatment is tolerated and how it affects the body after receiving injections. The trial is divided into two parts, with different groups of participants receiving varying doses of the treatment to see how it performs.

To be eligible for this study, participants must be between 18 and 65 years old and have a body mass index (BMI) that falls within specific ranges—either 18 to 30 for Part A or 25 to 30 for Part B. Participants will be closely monitored during the trial, and they should not have taken certain medications or have specific health conditions that could affect the results. This study is currently recruiting volunteers, and those who join can expect regular check-ins and assessments to ensure their safety and gather valuable information about the treatment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male or female participants, aged 18 to 65 years inclusive at the time of signing informed consent
• • 2. Body mass index (BMI) of 18 to 30kg/m2 (inclusive) for Part A, Body mass index (BMI) of 25 to 30kg/m2 (inclusive) for Part B and Body mass index (BMI) 30 kg/m² or higher for Part C
• • \[Exclusion Criteria\]
• 1. History of administration of prescription drugs, herbal medicines, over-the-counter drugs, or vitamin supplements within 10 days prior to the study or history of the following drugs and/or other foods within 90 days prior to screening:
• • Drugs that affect body weight (such as obesity medications, psychiatric drugs, beta blockers, diuretics, contraceptives, female hormones, proton-pump inhibitors (PPIs), H2 receptor antagonists, health functional foods/supplements, and formulas designed for weight control).
• • Drugs that have the potential to impact blood sugar, liver fat, and intestinal microorganisms (including GLP-1 receptor agonists, DPP-4 inhibitors, SGLT-2 inhibitors, thiazolidinediones (TZDs), fish oil, polyunsaturated fatty acids (PUFA), and ursodeoxycholic acid (UDCA)), as well as individuals who are currently using insulin.
• • 2. History of gastrointestinal diseases (Crohn's disease, ulcers, acute or chronic pancreatitis, etc.) or gastrointestinal surgery (excluding simple appendectomy or hernia surgery) that may affect the absorption of clinical trial drugs.
• • 3. History of acute proliferative retinopathy or maculopathy, severe gastroparesis, and/or severe neuropathy.
• • 4. History of surgical treatment for obesity within 2 years (example: bariatric surgery, gastric banding etc) or gastrointestinal procedures for weight loss (including LAP-BAND®), or uncontrolled gastrointestinal disorders at Screening (e.g., peptic ulcer, gastroesophageal reflux disease).