A Research Study Comparing Blood Levels of Medicines NNC0194-0499 and Semaglutide Administered as a Combination Formulation Versus Two Separate Formulations

What Was Tested

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

NASH is a serious disease where fat, inflammation and scar tissue builds up in the liver.

NNC0194-0499 is a new medicine which works in the liver.

It had three arms (groups): Group 1 (experimental), Group 2 (experimental) and Group 3 (experimental).

The registry classes the interventions as drug.

Who Took Part

53 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 or female. Aged 18-55 years (both inclusive) at the time of signing informed consent. Body mass index (BMI) between greater than or equal to 25 and less than or equal to 35 kilogram per meter square (kg/m\^2) (both inclusive).

The full record lists 4 inclusion and 4 exclusion criteria; among the exclusions: known or suspected hypersensitivity to study intervention(s) or related products; female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method; participation (that is, signed informed consent) in any other interventional clinical study within 90 days before first trial product administration (visit 2, day 1).

How the Study Was Run

Design: randomized, sequential and open-label.

Random assignment meant chance, not the researchers, decided who got Semaglutide and who got the comparison, which limits bias.

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

It started in 2023-03-02 with completion listed for 2024-01-05.

It ran at 1 site in Canada.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 5 secondary outcomes, for example Number of treatment emergent adverse events.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Semaglutide in 53 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.