A Research Study of How Oral Semaglutide Tablets Work in Healthy People Who Are Chinese

What Was Tested

This registered phase 1 trial tested Semaglutide.

This study looks at the way a new medicine tablet called semaglutide moves in and throughout the body over time.

The new medicine is planned to treat diabetes.

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

The registry classes the interventions as drug.

Who Took Part

The registry lists 32 actual participants took part.

It was open to people of any sex aged from 18 years up to 55 years.

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

Examples of who could join: Chinese male or female, aged 18-55 years (both inclusive) at the time of signing informed consent. Body weight equal to or above 54.0 kg. Body mass index (BMI) between 20.0 and 24.9 kg/m\^2 (both inclusive).

The full record lists 4 inclusion and 8 exclusion criteria; among the exclusions: history of pancreatitis (acute or chronic) as declared by the subject; family or personal history of multiple endocrine neoplasia type 2 (men2) or medullary thyroid carcinoma (mtc) as declared by the subject; smoker (defined as a subject who is smoking equal to or more than 1 cigarette or the equivalent per day).

How the Study Was Run

The set-up was 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.

As a double-blind Semaglutide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2019-10-08 with completion listed for 2021-01-23.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 12 secondary outcomes, for example CL/Fsema,SS, total apparent clearance of semaglutide at steady state, Ctrough,sema,SS, trough semaglutide plasma concentration at steady state, t½,sema,SS, terminal half-life of semaglutide at steady state, Vss/Fsema, apparent volume of distribution of semaglutide at steady state, MRTsema,SS, mean residence time of semaglutide at steady state and Rtheor,sema,SS, theoretical accumulation index, which is defined as [1/(1-Exp (-λZ,sema,SS*24h))], where λZ,sema,SS=log(2)/t½,sema,SS.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Semaglutide in 32 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.