Research Study Investigating How Well Semaglutide Works in People Suffering From Overweight or Obesity

What Was Tested

This registered phase 3 trial tested Semaglutide.

This study will look at the change in 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 medicine, the participant will have talks with study staff about healthy food choices, how to be more physically active and what a participant can do to lose weight.

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

The registry classes the interventions as drug.

Who Took Part

The registry lists 902 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. History of at least one self-reported unsuccessful dietary effort to lose body weight.

The full record lists 3 inclusion and 2 exclusion criteria; among the exclusions: A self-reported change in body weight more than 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.

Because people in this Semaglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

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

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

It started in 2018-06-04 with completion listed for 2020-02-22.

It ran at 72 sites in United States (28), Spain (7), Israel (6), Portugal (6), South Africa (6) and Switzerland (6).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change From Randomisation to Week 68 in Body Weight (%) (time frame: Randomisation (week 20) to week 68).

It also tracked 36 secondary outcomes, for example Change in Waist Circumference, Change in Systolic Blood Pressure, Change in Diastolic Blood Pressure, Change in Physical Functioning Score (Short Form 36 [SF-36]), Change in Body Weight [Kilogram (Kg)] and Change in Body Mass Index (BMI).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Semaglutide in 902 people.

With 902 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.