STEP 6: Research Study Investigating How Well Semaglutide Works in People Living With Overweight or Obesity

What Was Tested

The trial (phase 3) is built around Semaglutide.

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

It had four arms (groups): one (experimental), one (placebo comparator), one (experimental) and one (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 401 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 4 inclusion and 3 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.

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 2019-01-21 with completion listed for 2020-11-20.

It ran at 28 sites in Japan (22) and South Korea (6).

Its stated primary purpose is treatment.

What Was Measured

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

It also tracked 37 secondary outcomes, for example Change in Waist Circumference Measured Midway Between the Lower Rib Margin and the Iliac Crest, Change in Waist Circumference Measured According to the JASSO (Japan Society for the Study of Obesity) Guideline, Change in Body Weight (Kg), Change in Body Mass Index (BMI), Change in Visceral Fat Area (VFA) (%) and Change in Visceral Fat Area (VFA) Centimeter Square (cm^2).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Semaglutide in 401 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.