Investigating the Pharmacokinetics, Safety and Tolerability After a Single Subcutaneous Injection of Semaglutide in Subjects With Mild, Moderate or Severe Hepatic Impairment Compared to Subjects With Normal Hepatic Function

What Was Tested

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

This trial is conducted in Europe.

It had four arms (groups): Normal hepatic function (experimental), Mild hepatic impairment (experimental), Moderate hepatic impairment (experimental) and Severe hepatic impairment (experimental).

The registry classes the interventions as drug.

Who Took Part

44 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Male or female, age at least 18 years at the time of signing informed consent. Body mass index (BMI) 18.5-40.0 kg/m\^2 (both inclusive).

The full record lists 4 inclusion and 4 exclusion criteria; among the exclusions: mental inability, unwillingness or language barrier precluding adequate understanding of or compliance with trial procedures.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

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.

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

It started in 2014-08-07 with completion listed for 2015-06-03.

It ran at 4 sites in Poland (2) and Slovakia (2).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Area under the semaglutide plasma concentration-time curve (time frame: Day 1 - day 36).

It also tracked 2 secondary outcomes, for example Maximum observed semaglutide plasma concentration and Number of treatment emergent adverse events (TEAEs).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Semaglutide in 44 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.