Research Study of How Well Semaglutide Works in People Living With Overweight or Obesity.

What Was Tested

This registered phase 3 trial tested Semaglutide.

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

The purpose of the study 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 medicine participants will have talks with study staff about healthy food choices, how to be more physically active and what else they can do to lose weight.

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

The registry classes the interventions as drug.

Who Took Part

The registry lists 375 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 18 years or older at the time of signing informed consent. History of at least one self-reported unsuccessful dietary effort to lose body weight. Body mass index (BMI) of :. Greater than or equal to 30 kg/m\^2. Greater than or equal to 27 kg/m\^2 with the presence of at least one of the following weight-related comorbidities (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease.

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

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 2020-12-08 with completion listed for 2022-08-23.

It ran at 33 sites in China (28), Brazil (2), South Korea (2) and Hong Kong (1).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change From Baseline in Body Weight (Percentage [%]) (time frame: Baseline (week 0), week 44).

It also tracked 41 secondary outcomes, for example Change From Baseline in Waist Circumference, Change From Baseline in Body Weight (Kilogram [kg]), Change From Baseline in Body Mass Index (BMI), Change From Baseline in Systolic Blood Pressure, Change From Baseline in Short Form-36 (SF-36) - Physical Functioning Score and Change From Baseline in Glycosylated Haemoglobin (HbA1c) (Percentage [%]).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Semaglutide in 375 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.