Research Study Investigating How Well Semaglutide Works in People With Type 2 Diabetes Suffering From Overweight or Obesity

What Was Tested

This registered phase 3 trial tested Semaglutide.

This study will look at the change in the participant's body weight from the start to the end of the study.

This is to compare the effect on body weight in people taking semaglutide (a new medicine) and people taking "dummy" medicine.

In addition to taking the study medicine, the participant will have talks with study staff about healthy food choices, how to be more physically active and what else the participant can do to lose weight.

It had three arms (groups): one (experimental), one (experimental) and Semaglutide placebo I/II (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

1210 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Male or female, age greater than or equal to 18 years at the time of signing informed consent. Body Mass Index (BMI) greater than or equal to 27 kg/m\^2 '. History of at least one self-reported unsuccessful dietary effort to lose body weight.

The full record lists 4 inclusion and 3 exclusion criteria; among the exclusions: A self-reported change in body weight greater than 5 kg (11 lbs) within 90 days before screening irrespective of medical records.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

The participants were allocated by chance, so the Semaglutide group and the comparison group should start out alike.

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

Neither the participants nor the staff measuring them knew who was on Semaglutide, so expectations could not easily colour the readings.

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

It started in 2018-06-04 with completion listed for 2020-03-24.

It ran at 147 sites in United States (50), India (16), Japan (12), Canada (10), United Kingdom (10) and Germany (9).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in Body Weight (%) - Semaglutide [amount hidden] Versus Placebo.

It also tracked 39 secondary outcomes, for example Change in Waist Circumference, Change in Body Weight (Kg), Change in BMI, Change in HbA1c (%), Change in HbA1c (mmol/Mol) and Change in FPG (mg/dL).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Semaglutide in 1210 people.

With 1210 participants it is a large trial for this field.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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