Research Study Looking at How Well Semaglutide Tablets Taken Once Daily Work in People Who Have a Body Weight Above the Healthy Range

What Was Tested

The trial (phase 3) is built around Semaglutide.

This study will look how well semaglutide tablets taken once daily helps people with body weight above the healthy range.

This study will last for 72 weeks, which includes 1-week screening period, 64 weeks of treatment period and 7 weeks of follow up period.

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

Participants will receive placebo tablets matched to semaglutide orally once daily for 64 weeks.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 307 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: Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study. Male or female, age greater than or equal to 18 years at the time of signing informed consent. Body mass index (BMI) of. Greater than or equal to 30.0 kg/m\^2. History of at least one self-reported unsuccessful dietary effort to lose body weight.

The full record lists 6 inclusion and 2 exclusion criteria; among the exclusions: A self-reported change in body weight greater than 5 kg (11 pound \[lbs\]) 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.

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 2022-10-11 with completion listed for 2024-04-18.

It ran at 23 sites in Germany (8), United States (7), Poland (6) and Canada (2).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Percentage Change in Body Weight (time frame: Baseline (week 0), end of treatment (week 64)).

It also tracked 25 secondary outcomes, for example Change in Physical Function Domain (5-items) Score Impact of Weight on Quality of Life-Lite for Clinical Trials (IWQOL-Lite for CT), Number of Participants Who Achieved ≥14.6 IWQOL-Lite-CT Physical Function Domain (PFD) Score (Yes/No), Change in Body Weight - Kilogram (kg), Change in Body Mass Index (BMI), Change in Waist Circumference and Change in Systolic Blood Pressure.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Semaglutide in 307 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.