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A Research Study Looking at How [amount hidden] Semaglutide Daily Affects Food Intake and Emptying of the Stomach in People With Obesity

Plain-language guide to NCT05236517: phase 1 randomized trial of Semaglutide, 60 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT05236517
Phase
phase 1
Status
completed
Start
2022-02-08
Completion (planned or actual)
2022-09-29
Participants
60 (actual)
Design
randomized, quadruple-blind, treatment
Conditions studied
Obesity
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

This registered phase 1 trial tested Semaglutide.

In addition, how much semaglutide is in the blood will also be tested.

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

The registry classes the interventions as drug.

Who Took Part

The registry lists 60 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Male or female, aged 18-65 years (both inclusive) at the time of signing informed consent. Body mass index between 30.0 and 45.0 kilogram per meter square (kg/m\^2) (both inclusive).

The full record lists 2 inclusion and 3 exclusion criteria; among the exclusions: any disorder which in the investigator's opinion might jeopardise participant safety or compliance with the protocol; presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, gastrointestinal, or endocrinological conditions.

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.

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 2022-02-08 with completion listed for 2022-09-29.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Relative change in energy intake during ad libitum lunch (time frame: Baseline to Day 140).

It also tracked 20 secondary outcomes, for example Change in energy intake during ad libitum lunch, Change in amount of food consumed during ad libitum lunch, Change in body weight, AUC0-5h,para, AUC0-1h,para and Cmax,para.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Semaglutide in 60 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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.