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A Research Study Looking at New Protein-based Tablets in Healthy Men - Oral Formulation IV

Plain-language guide to NCT06642584: phase 1 randomized trial of Semaglutide, 90 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT06642584
Phase
phase 1
Status
completed
Start
2024-10-15
Completion (planned or actual)
2025-07-10
Participants
90 (actual)
Design
randomized, open label (everyone knows who gets what), treatment
Conditions studied
Healthy Volunteers Type 2 Diabetes
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

In this phase 1 trial, researchers set out to test Semaglutide.

It is done to test how semaglutide in each of the tablet versions is taken up in the body.

Which treatments participants will receive is decided by chance.

It had six arms (groups): Sequence 1: Semaglutide J then Semaglutide L (experimental), Sequence 2: Semaglutide L then Semaglutide J (experimental), Sequence 3: Semaglutide J then Semaglutide M (experimental), Sequence 4: Semaglutide M then Semaglutide J (experimental) and Sequence 5: Semaglutide J then Semaglutide N (experimental).

Participants will receive subcutaneously semagutide B in treatment period 1 followed by oral semaglutide J then semaglutide L in treatment period 2.

Participants will receive subcutaneously semagutide B in treatment period 1 followed by oral semaglutide L then semaglutide J in treatment period 2.

Participants will receive subcutaneously semagutide B in treatment period 1 followed by oral semaglutide J then semaglutide M in treatment period 2.

The registry classes the interventions as drug.

Who Took Part

The registry lists 90 actual participants took part.

It was open to men only aged from 18 years up to 64 years.

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

Examples of who could join: Age 18-64 years (both inclusive) at the time of signing the informed consent. Body mass index (BMI) between 22.0 and 31.9 kilogram per square meter (kg/m\^2) (both inclusive) at screening.

The full record lists 4 inclusion and 3 exclusion criteria; among the exclusions: known or suspected hypersensitivity to study interventions or related products; any condition which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.

How the Study Was Run

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

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

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

Being open-label, the Semaglutide study did not mask who received what.

It started in 2024-10-15 with completion listed for 2025-07-10.

It ran at 1 site in Canada.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Adjusted AUC(sema); adjusted area under the semaglutide plasma concentration-time curve. Adjusted Cmax,(sema); adjusted maximum observed semaglutide plasma concentration. Adjusted tmax,sema; time to adjusted maximum observed semaglutide plasma concentration.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Semaglutide in 90 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.