Phase 2 Randomized Study of PG-102 vs Placebo and Semaglutide in Type 2 Diabetes Mellitus

What Was Tested

In this phase 2 trial, researchers set out to test Semaglutide.

Phase 2 Randomized Study of PG-102 vs Placebo and Semaglutide in Type 2 Diabetes Mellitus.

It had three arms (groups): PG-102 (experimental), Placebo (placebo comparator) and Semaglutide (active comparator).

Participants receive matching placebo administered subcutaneously once weekly.

The registry classes the interventions as drug.

Who Took Part

The registry lists 80 planned participants were the target.

It was open to people of any sex aged from 18 years up to 75 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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. Body mass index (BMI) ≥25 to \<40 kg/m2 at screening.

The full record lists 5 inclusion and 10 exclusion criteria; among the exclusions: 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.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

Random assignment meant chance, not the researchers, decided who got Semaglutide and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Blinding on both sides kept the participants and researchers unaware of who received Semaglutide.

Those kept unaware of assignments: participant and investigator.

It started in 2026-01 with completion listed for 2026-09.

It ran at 1 site in Australia.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Absolute change in HbA1c From Baseline at Week 24 (time frame: 24 weeks).

It also tracked 8 secondary outcomes, for example Absolute change in HbA1c from baseline to 12 weeks, Absolute Change in Body Weight From Baseline at Week 12 and 24, Percent Change in Body Weight From Baseline at Week 12 and 24, Change in Fasting Plasma Glucose (FPG) From Baseline at Week 12 and 24, Change in 7-Point Self-Monitored Plasma Glucose (SMPG) Profile at Week 12 and 24 and Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Semaglutide in 80 people.

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Semaglutide compound page, all human trials.