Trial to Learn About the Study Medicine (PF-07081532) and Rybelsus in People With Type 2 Diabetes and Separately PF-07081532 in People With Obesity

What Was Tested

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

Individuals diagnosed with diabetes that are on metformin or individuals with obesity without diabetes will be included in the study.

Those participating in the diabetes part of the study, will receive either active study drug, placebo, or an approved treatment called Rybelsus.

It had 13 arms (groups): one (experimental), one (experimental), one (experimental), one (experimental) and one (experimental).

The registry classes the interventions as drug and other.

Who Took Part

The registry lists 902 actual participants took part.

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: T2DM inadequately controlled with metformin. BMI ≥23.0 kg/m2 (≥20.0 kg/m2 in Japan). BMI ≥30.0 kg/m2.

The full record lists 7 inclusion and 9 exclusion criteria; among the exclusions: T2DM:Use of any agent (other than metformin)for the explicit purpose of glycemic control;History of diabetic ketoacidosis;Proliferative retinopathy or maculopathy requiring acute treatment;; uncontrolled blood pressure; personal or within first-degree relative family history of mtc or men2.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

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.

As a double-blind Semaglutide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2022-10-27 with completion listed for 2023-07-14.

It ran at 90 sites in United States (39), Canada (11), Japan (11), Czechia (8), Hungary (7) and Poland (7).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Placebo-adjusted, Change From Baseline in Percentage of Glycated Hemoglobin (HbA1c) at Week 32: Cohort 1 (Type 2 Diabetes Mellitus). Placebo-adjusted, Percent Change From Baseline in Body Weight at Week 32: Cohort 2 (Obesity).

It also tracked 24 secondary outcomes, for example Change From Baseline in Fasting Plasma Glucose (FPG) at Week 32: Cohort 1 (Type 2 Diabetes Mellitus), Percent Change From Baseline in Body Weight at Week 32: Cohort 1 (Type 2 Diabetes Mellitus), Placebo-adjusted, Change From Baseline in HbA1C in the Rybelsus Arm at Week 32: Cohort 1 (Type 2 Diabetes Mellitus), Absolute Change From Baseline in Waist Circumference at Week 32: Cohort 2 (Obesity), Absolute Change From Baseline in Waist-to-hip Ratio at Week 32: Cohort 2 (Obesity) and Change From Baseline in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) at Week 32: Cohort 2 (Obesity).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Semaglutide in 902 people.

With 902 participants it is a large trial for this field.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

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