Research Study Looking at How Well Semaglutide Works in People Living With Obesity and Prediabetes

What Was Tested

This registered phase 3 trial tested Semaglutide.

This study looks at how well a new medicine, called semaglutide, works at helping people with obesity and prediabetes.

This study will look at how much weight participants lose, and if participants can go from having blood sugar that is higher than normal (prediabetes) to having normal blood sugar.

Semaglutide is compared to a "dummy" medicine.

It had two arms (groups): Semaglutide (experimental) and Placebo (semaglutide) (placebo comparator).

Participants will receive subcutaneus (s.c.) placebo (semaglutide) once weekly for 52 weeks.

The registry classes the interventions as drug.

Who Took Part

The registry lists 207 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 aged greater than or equal to 18 years at the time of signing informed consent. BMI greater than or equal to 30.0 kg/m\^2. Prediabetes defined as at least one of the following:.

The full record lists 5 inclusion and 5 exclusion criteria; among the exclusions: history of type 1 or type 2 diabetes; treatment with glucose-lowering agent(s) within 90 days before screening; treatment with any medication for the indication of obesity within the past 90 days before screening.

How the Study Was Run

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

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

The Semaglutide group and the comparison group ran side by side rather than switching.

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 2021-09-06 with completion listed for 2023-01-06.

It ran at 43 sites in Canada (28), United Kingdom (8), Spain (3), Denmark (2) and Finland (2).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in Body Weight (Percentage [%]) (time frame: From randomisation (week 0) to end of treatment (week 52)). Participants With Change to Normoglycemia (time frame: At week 52).

It also tracked 15 secondary outcomes, for example Change in Glycosylated Haemoglobin (HbA1c), Change in Fasting Plasma Glucose (FPG), Change in Waist Circumference, Change in Systolic Blood Pressure, Change in Triglycerides (Millimoles Per Liter [mmol/L]) - Ratio to Baseline and Change in Total Cholesterol (mmol/L) - Ratio to Baseline.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Semaglutide in 207 people.

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.