A Trial Investigating the Effect of Oral Semaglutide on the Pharmacokinetics of Furosemide and Rosuvastatin in Healthy Subjects

What Was Tested

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

This trial is conducted in Europe.

It had 1 arm (groups): Furosemide/Rosuvastatin/SNAC/Semaglutide (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 41 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial. Male or female, aged 18-65 years (both inclusive) at the time of signing informed consent. Body mass index (BMI) between 20.0-29.9 kg/m\^2 (both inclusive).

The full record lists 4 inclusion and 8 exclusion criteria; among the exclusions: smoker (defined as a subject who is smoking at least one cigarette or the equivalent per day); history of major surgical procedures involving the stomach potentially affecting absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery); have personal or family history of myopathy.

How the Study Was Run

Design: single-group and open-label.

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

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2017-01-05 with completion listed for 2017-06-04.

It ran at 1 site in United Kingdom.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Area under the furosemide plasma concentration-time curve (time frame: day 1, day 7, day 54). Area under the rosuvastatin plasma concentration-time curve (time frame: day 2, day 8, day 55).

It also tracked 2 secondary outcomes, for example Maximum observed furosemide plasma concentration and Maximum observed rosuvastatin plasma concentration.

What This Means in Plain Language

Put simply, this is a phase 1 trial of Semaglutide in 41 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.