Investigating the Influence of Semaglutide on the Pharmacokinetics of Single Doses of Atorvastatin and Digoxin in Healthy Subjects

What Was Tested

The trial (phase 1) is built around Semaglutide.

The trial is conducted in Europe.

It had 1 arm (groups): Semaglutide (experimental).

The registry classes the interventions as drug.

Who Took Part

31 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: Male and female, age between 18 and 55 years (both inclusive) at the time of signing informed consent. Body mass index between 20.0 and 29.9 kg/m\^2 (both inclusive).

The full record lists 2 inclusion and 6 exclusion criteria; among the exclusions: history of drug/chemical substance abuse within 1 year from screening, or a positive result in the urine drug test; smoking in the last 3 months prior to screening or a positive nicotine test.

How the Study Was Run

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

Each person switched between Semaglutide and the comparison at some point, usually with a gap in between.

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

It started in 2014-09-16 with completion listed for 2015-04-07.

It ran at 1 site in Germany.

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: Area under the atorvastatin plasma concentration-time curve. Area under the digoxin plasma concentration-time curve.

It also tracked 3 secondary outcomes, for example Maximum observed atorvastatin plasma concentration, Maximum observed digoxin plasma concentration and Number of treatment emergent AEs (TEAEs).

What This Means in Plain Language

Put simply, this is a phase 1, non-randomized trial of Semaglutide in 31 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.