Effects of NNC0194-0499, Cagrilintide, and Semaglutide Alone or in Combinations on Liver Damage and Alcohol Use in People With Alcohol-related Liver Disease

What Was Tested

The trial (phase 2) is built around Cagrilintide and Semaglutide.

The study will look at the effects of NNC0194-0499, cagrilintide and semaglutide, on liver damage and alcohol use in participants with alcoholic liver disease.

Participants will get NNC0194-0499, semaglutide, cagrilintide or ''dummy" medicine in different treatment combinations.

Which treatment participants get is decided by chance.

It had seven arms (groups): NNC0194-0499 + semaglutide (experimental), NNC0194-0499 + semaglutide placebo (experimental), NNC0194-0499 placebo + semaglutide (experimental), NNC0194-0499 placebo + semaglutide placebo (placebo comparator) and CagriSema (experimental).

Group A: Participants will receive subcutaneous (s.c.) injections of NNC0194-0499 in combination with semaglutide.

Group A: Participants will receive subcutaneous (s.c.) injections of NNC0194-0499 in combination with semaglutide placebo.

Group A: Participants will receive subcutaneous (s.c.) injections of NNC0194-0499 placebo in combination with semaglutide.

The registry classes the interventions as drug.

Who Took Part

The registry lists 270 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study. Age 18 years or above, and at the legal drinking age according to local requirements at the time of signing the informed consent.

The full record lists 4 inclusion and 10 exclusion criteria; among the exclusions: known or suspected hypersensitivity to study intervention(s) or related products (incl. excipients); documented causes of chronic liver disease other than alcohol-related liver disease (ald); presence or history of ascites more than grade 1, variceal bleeding, hepatic encephalopathy, spontaneous bacterial peritonitis, or liver transplantation at screening (v1).

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

Because people in this Cagrilintide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

Neither the participants nor the staff measuring them knew who was on Cagrilintide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2024-05-20 with completion listed for 2025-11-21.

It ran at 102 sites in United States (29), Japan (13), Australia (8), Poland (8), Germany (7) and Bulgaria (6).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in Enhanced Liver Fibrosis (ELF) (time frame: From week 0 to week 28).

It also tracked 9 secondary outcomes, for example Change in Pro-peptide of Collagen 3 (Pro-C3), Change in liver stiffness assessed by Vibration Controlled Transient Elastography (VCTE), Change in liver steatosis assessed by Controlled Attenuated Parameter (CAP), Change in Alanine Aminotransferase (ALT), Change in Aspartate Aminotransferase (AST) and Number of treatment emergent adverse events.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Cagrilintide and Semaglutide in 270 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Cagrilintide compound page and the Semaglutide compound page, all human trials.