Research Study to Look at How Well Semaglutide is at Lowering Weight When Taken Together With an Intensive Lifestyle Program

What Was Tested

In this phase 3 trial, researchers set out to test 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.

Together with the medicine, the participant will also be part of an intensive lifestyle program where the participant will have talks with study staff about healthy food choices, what the participant can do to lose weight and be more physically active.

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

Participants will receive semaglutide placebo during 68-week treatment period in addition to intensive behavioural therapy.

The registry classes the interventions as drug.

Who Took Part

611 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 more 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

It was run as a randomized, parallel-group and quadruple-blind study.

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.

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 2018-08-01 with completion listed for 2020-03-18.

It ran at 41 sites in United States (41).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in Body Weight (%) (time frame: Baseline (week 0) to week 68).

It also tracked 29 secondary outcomes, for example Change in Waist Circumference, Change in Systolic Blood Pressure, Change in Short Form-36 (SF-36) - Physical Functioning Score, Change in Body Weight (Kg), Change in Body Mass Index and Change in HbA1c (%).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Semaglutide in 611 people.

With 611 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.