Research Study to Investigate How Well Semaglutide Tablets Taken Once Daily Work in East Asian People Who Are Overweight or Living With Obesity

What Was Tested

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

This study will look at the change in participants' body weight.

Participants will either get semaglutide tablets (new medicine) or placebo tablets ('dummy' medicine that looks like semaglutide but has no effect on the body).

It had two arms (groups): one (experimental) and oral semaglutide placebo once daily (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 201 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 above 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. Diagnosed with T2D greater than or equal to 180 days prior to screening.

The full record lists 7 inclusion and 13 exclusion criteria; among the exclusions: history of type 1 or type 2 diabetes; treatment with glucose-lowering agent(s) within 90 days prior to screening; treatment with any medication for the indication of diabetes other than stated in the inclusion criteria within the past 60 days prior to screening.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

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

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

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 2021-11-16 with completion listed for 2023-07-11.

It ran at 15 sites in Japan (11) and South Korea (4).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Percent Change From Baseline in Body Weight (time frame: Baseline (week 0), week 68).

It also tracked 20 secondary outcomes, for example Change From Baseline in Body Mass Index (BMI), Change From Baseline in Waist Circumference Measured According to the JASSO (Japan Society for the Study of Obesity) Guideline, Change From Baseline in Visceral Fat Area (VFA) Measured by CT Scan in a Subset of the Japanese Study Population (%), Change From Baseline in Visceral Fat Area (VFA) Measured by CT Scan in a Subset of the Japanese Study Population (Centimeter Square [cm^2]), Change From Baseline in Systolic Blood Pressure and Change From Baseline in Diastolic Blood Pressure.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Semaglutide in 201 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.