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A Clinical Trial Looking at the Comparability of 2 Different Forms of Semaglutide

Plain-language guide to NCT05232708: phase 1 randomized trial of Semaglutide, 18 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT05232708
Phase
phase 1
Status
completed
Start
2022-01-19
Completion (planned or actual)
2022-08-30
Participants
18 (actual)
Design
randomized, open label (everyone knows who gets what), treatment
Conditions studied
Healthy Volunteers (Diabetes Mellitus, Type 2)
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

This registered phase 1 trial tested Semaglutide.

In this trial, two approved solutions of the medicine semaglutide will be compared in healthy volunteers.

The purpose of this trial is to see if semaglutide B and semaglutide D solutions are comparable with regards to moving into, through and out of the body when given in two separate injections.

Participants will receive semaglutide B and semaglutide D in different periods of the trial (Period 1 and Period 2).

It had two arms (groups): one (experimental) and one (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 18 actual participants took part.

It was open to people of any sex aged from 20 years up to 55 years.

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

Examples of who could join: Male or female. Aged 20-55 years (both inclusive) at the time of signing informed consent. Body mass index (BMI) between 25.0 and 34.9 kilogram per meter square (kg/m\^2) (both inclusive).

The full record lists 3 inclusion and 9 exclusion criteria; among the exclusions: female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method; any disorder which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol; abuse or intake of alcohol, defined as any of the below:.

How the Study Was Run

It was run as a randomized, crossover and open-label study.

The participants were allocated by chance, so the Semaglutide group and the comparison group should start out alike.

Each person switched between Semaglutide and the comparison at some point, usually with a gap in between.

Nothing was hidden in this open-label Semaglutide study: the participants and staff both knew the treatment.

It started in 2022-01-19 with completion listed for 2022-08-30.

It ran at 1 site in United Kingdom.

Its stated primary purpose is treatment.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Semaglutide in 18 people.

Its size is small, so on its own it can only give an early look.

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.