Pharmacokinetics, Safety and Tolerability of Oral Semaglutide in Subjects With Hepatic Impairment

What Was Tested

The trial (phase 1) is built around Semaglutide.

This trial is conducted in Europe.

It had two arms (groups): Subjects with hepatic impairment (experimental) and Subjects with normal hepatic function (active comparator).

The registry classes the interventions as drug.

Who Took Part

56 actual participants took part.

It was open to people of any sex aged from 18 years up to 85 years.

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

Examples of who could join: Subject with normal hepatic function or hepatic impairment (mild, moderate or severe). Body mass index (BMI) 18.5-40.0 kg/m\^2 (both inclusive).

The full record lists 2 inclusion and 5 exclusion criteria; among the exclusions: female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods; history of crohn's disease, ulcerative colitis, or other inflammatory bowel disease; uncontrolled hypertension (defined as systolic blood pressure above or equal to 180 mmhg and/or diastolic blood pressure above or equal to 100 mmhg).

How the Study Was Run

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

The Semaglutide group and the comparison group ran side by side rather than switching.

Everyone knew when Semaglutide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2013-12-12 with completion listed for 2015-01-12.

It ran at 6 sites in Poland (3), Czechia (2) and Slovakia (1).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Area under the semaglutide plasma concentration curve.

It also tracked 3 secondary outcomes, for example Maximum observed semaglutide plasma concentration, Area under the SNAC (Sodium N-[8-(2-hydroxybenzoyl) amino] caprylate /salcaprozate sodium) plasma concentration time curve and Maximum observed SNAC plasma concentration.

What This Means in Plain Language

Put simply, this is a phase 1, non-randomized trial of Semaglutide in 56 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.