Pharmacokinetics, Safety and Tolerability of Oral Semaglutide in Subjects With Various Degrees of Impaired Renal Function

What Was Tested

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

This trial is conducted in Europe.

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

The registry classes the interventions as drug.

Who Took Part

71 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: Male or female aged 18-85 years (both inclusive) at the time of signing inform consent. Subject with normal renal function or renal impairment (mild, moderate, severe or end-stage renal disease requiring dialysis). For subject with normal renal function: good general health (as judged by the investigator). Body mass index (BMI) 18.5-40.0 kg/m\^2 (both inclusive).

The full record lists 4 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

It was run as a non-randomized, parallel-group and open-label study.

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

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

It started in 2013-12-11 with completion listed for 2014-10-24.

It ran at 4 sites in Czechia (2) and Hungary (2).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Area under the semaglutide plasma concentration time 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 71 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.