Phase 2 Randomized Study of PG-102 vs Placebo and Semaglutide in Type 2 Diabetes Mellitus
Must have given written informed consent before any study-related activities are performed and must be able to understand the full nature and purpose of the study, including possible risks and adverse effects.
Adult males and females, 18 to 75 years of age (inclusive) on the day of signing the informed consent form (ICF).
Must have a diagnosis of T2DM for at least 6 months before screening based on the disease diagnostic criteria.
Must have an HbA1c value at screening of ≥7.0% and ≤10.0% (≥53 and ≤86 mmol/mol) and treated with diet and exercise alone or a stable dose of metformin (either immediate release or extended release, ≥1000 mg/day and not more than the locally approved dose) for at least 3 months prior to screening.
Have a diagnosis of type 1 diabetes.
History of severe hypoglycaemia and/or hypoglycaemia unawareness within 6 months prior to screening.
Have active proliferative diabetic retinopathy or history of uncontrolled and potentially unstable diabetic retinopathy or maculopathy.
History of or current chronic pancreatitis, or acute pancreatitis within the past 6 months prior to screening.
Parallel
PG-102
DrugPG-102 is administered subcutaneously once weekly with a titration regimen.
Placebo
DrugPlacebo is administered subcutaneously once weekly.
Semaglutide
DrugOpen-label semaglutide is administered subcutaneously once weekly with titration regimen.
Absolute change in HbA1c From Baseline at Week 24
Mean absolute change in glycated hemoglobin (HbA1c) from baseline to Week 24, comparing PG-102 with placebo.
Absolute change in HbA1c from baseline to 12 weeks
Mean absolute change in HbA1c from baseline to Week 12.
Absolute Change in Body Weight From Baseline at Week 12 and 24
Mean absolute change in body weight from baseline to Weeks 12 and 24.
Percent Change in Body Weight From Baseline at Week 12 and 24
Mean percent change in Body Weight from baseline to Week 12 and 24.
Change in Fasting Plasma Glucose (FPG) From Baseline at Week 12 and 24.
Mean change in fasting plasma glucose (mg/dL) from baseline to Week 12 and 24.
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This trial is not recruiting at the moment. You can still explore other options:
