A Trial to Assess the Pharmacokinetics, Safety and Tolerability of Semaglutide in Healthy Chinese Subjects

What Was Tested

The trial (phase 1) is built around Semaglutide.

Participants will be administered semaglutide or placebo once-weekly by subcutaneous injection (under the skin fold of the abdominal wall) using a pen injector with a very small, thin needle by the trial doctor at the trial site for 13 weeks.

It had four arms (groups): one (experimental), one (placebo comparator), one (experimental) and one (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

36 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: Healthy male and female Chinese subjects. Age between 18 to 55 years (both inclusive) at the time of signing informed consent. Body mass index (BMI) between 20 and 24.9 kg/sqm (both inclusive). Body weight greater than or equal to 54.0 kg.

The full record lists 4 inclusion and 7 exclusion criteria; among the exclusions: personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2; history of pancreatitis (acute or chronic); calcitonin greater than or equal to 50 ng/l.

How the Study Was Run

Design: 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 2017-09-21 with completion listed for 2018-07-10.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Area under the semaglutide plasma concentration time curve at steady state (semaglutide [amount hidden]). Area under the semaglutide plasma concentration time curve at steady state (semaglutide [amount hidden]).

It also tracked 13 secondary outcomes, for example Maximum observed semaglutide plasma concentration at steady state, Time to maximum observed semaglutide plasma concentration at steady state, Total apparent clearance of semaglutide at steady state, Terminal elimination half-life of semaglutide at steady state, Apparent volume of distribution of semaglutide at steady state and Trough plasma semaglutide concentration.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Semaglutide in 36 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.