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Research Study Investigating How Well Semaglutide Works in People From Thailand and South Korea Living With Obesity
Plain-language guide to NCT04998136: phase 3 randomized trial of Semaglutide, 150 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT04998136
- Phase
- phase 3
- Status
- completed
- Start
- 2022-08-15
- Completion (planned or actual)
- 2023-10-16
- Participants
- 150 (actual)
- Design
- randomized, quadruple-blind, treatment
- Conditions studied
- Obesity
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
This registered phase 3 trial tested Semaglutide.
This study looks at how well semaglutide helps people lose weight.
This study will look at the change in the participants' body weight from the start to the end of the study.
The study compares the weight loss in people who get semaglutide to the weight loss in people who get placebo.
It had two arms (groups): one (experimental) and Placebo (placebo comparator).
The registry classes the interventions as drug.
Who Took Part
150 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: Age above or equal to 18 years at the time of signing informed consent. BMI at least 25.0 kg/m\^2 at screening. Both parents of Asian descent. History of at least one self-reported unsuccessful dietary effort to lose body weight.
The full record lists 4 inclusion and 5 exclusion criteria; among the exclusions: history of type 1 or type 2 diabetes mellitus; A self-reported change in body weight above 5 kg (11 lbs) within 90 days before screening irrespective of medical records; any participant where a substantial weight loss, in the investigator's opinion, might jeopardise the participant's safety.
How the Study Was Run
Design: 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.
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 2022-08-15 with completion listed for 2023-10-16.
It ran at 16 sites in Thailand (9) and South Korea (7).
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Change in Body Weight (%) : In-trial Observation Period (time frame: Baseline (week 0), end of treatment (week 44)). Change in Body Weight (%) : On-treatment Observation Period (time frame: Baseline (week 0), end of treatment (week 44)).
It also tracked 19 secondary outcomes, for example Change in Waist Circumference, Change in Body Weight (kg), Change in Body Mass Index, Change in Systolic Blood Pressure (mmHg), Change in Diastolic Blood Pressure and Change in Total Cholesterol (mg/dL) - Ratio to Baseline.
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Semaglutide in 150 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.
Our Notes on the Compound
Semaglutide: The active ingredient in several prescription GLP-1 receptor agonist medicines (Ozempic, Wegovy, oral tablets).
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.