STEP 1: Research Study Investigating How Well Semaglutide Works in People Suffering From 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.

The weight loss in participants taking semaglutide (a new medicine) will be compared to the weight loss of participants 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 you can do to lose weight.

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

Participants will receive semaglutide for 68 weeks.

Participants will receive semaglutide matching placebo for 68 weeks.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 1961 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. Informed consent for the extension phase obtained before any trial related activities for the extension phase.

The full record lists 5 inclusion and 4 exclusion criteria; among the exclusions: A self-reported change in body weight greater than 5 kg (11 lbs) within 90 days before screening irrespective of medical records; female who is pregnant or intends to become pregnant during the extension phase.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Semaglutide and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

As a double-blind Semaglutide study, the assignments were hidden from both participants and investigators until the end.

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

It started in 2018-06-04 with completion listed for 2020-03-30.

It ran at 128 sites in United States (39), Germany (13), India (13), United Kingdom (10), Russia (8) and Canada (7).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in Body Weight (%) (time frame: Baseline (week 0) to week 68).

It also tracked 40 secondary outcomes, for example Change in Waist Circumference (cm), Change in Systolic Blood Pressure (mmHg), Change in Short Form 36 (SF-36), Change in Impact of Weight on Quality of Life-Lite for Clinical Trial (IWQoL-Lite for CT) Score, Change in Body Weight (kg) and Change in Body Mass Index (BMI) (kg/m2).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Semaglutide in 1961 people.

With 1961 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.