← Human Trials & Peer-Reviewed Studies
Investigation of Safety and Efficacy of Once-daily Semaglutide in Obese Subjects Without Diabetes Mellitus
Plain-language guide to NCT02453711: phase 2 randomized trial of Semaglutide and Liraglutide, 957 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02453711
- Phase
- phase 2
- Status
- completed
- Start
- 2015-10-01
- Completion (planned or actual)
- 2017-03-30
- Participants
- 957 (actual)
- Design
- randomized, double-blind, treatment
- Conditions studied
- Metabolism and Nutrition Disorder; Obesity
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
This registered phase 2 trial tested Semaglutide and Liraglutide.
This trial is conducted globally.
It had 16 arms (groups): one (experimental), one (experimental), one (experimental), one (experimental) and one (experimental).
The registry classes the interventions as drug.
Who Took Part
957 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.
The full record lists 0 inclusion and 1 exclusion criteria.
How the Study Was Run
Design: randomized, parallel-group and double-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 and investigator.
It started in 2015-10-01 with completion listed for 2017-03-30.
It ran at 74 sites in United States (22), Russia (11), Canada (9), United Kingdom (8), Germany (7) and Israel (7).
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Relative Change in Body Weight (%) (time frame: Week 0, Week 52).
It also tracked 36 secondary outcomes, for example Change in Body Weight (kg), Change in Waist Circumference, Change in Waist to Hip Circumference Ratio, Change in BMI, Change in HbA1c and Change in FPG.
What This Means in Plain Language
Put simply, this is a phase 2, randomized trial of Semaglutide and Liraglutide in 957 people.
With 957 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 and the Liraglutide compound page, all human trials.
Our Notes on the Compounds
Semaglutide: The active ingredient in several prescription GLP-1 receptor agonist medicines (Ozempic, Wegovy, oral tablets).
Liraglutide: A once-daily GLP-1 receptor agonist peptide; sold as Victoza for type 2 diabetes and Saxenda for weight management.
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.