Phase 2 Randomized Study of PG-102 vs Placebo and Semaglutide in Type 2 Diabetes Mellitus
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
80
PG-102 is administered subcutaneously once weekly with a titration regimen.
Placebo is administered subcutaneously once weekly.
Open-label semaglutide is administered subcutaneously once weekly with titration regimen.
Emeritus Research
Camberwell, Victoria, Australia
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.
Time frame: 24 weeks
Absolute change in HbA1c from baseline to 12 weeks
Mean absolute change in HbA1c from baseline to Week 12.
Time frame: 12 weeks
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.
Time frame: 12 and 24 weeks
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.
Time frame: 12 and 24 weeks
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.
Time frame: 12 and 24 weeks
Change in 7-Point Self-Monitored Plasma Glucose (SMPG) Profile at Week 12 and 24.
Mean change in the 7-point SMPG profile from baseline to Week 12 and 24.
Time frame: 12 and 24 weeks
Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Number and percentage of participants experiencing TEAEs, SAEs, and discontinuations due to adverse events.
Time frame: 24 weeks
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Incidence of Adverse Events of Special Interest (AESIs) - Gastrointestinal
Incidence and severity of GI-related AESIs (e.g., nausea, vomiting, diarrhea).
Time frame: 24 weeks
Incidence of anti-drug antibodies (ADA) to PG-102
Number and percentage of participants developing anti-drug antibodies against PG-102.
Time frame: 24 weeks