This is a registry record, not a result. A trial being listed, recruiting or completed says nothing by itself about whether the compound works or is safe.
| Registry number | NCT05016882 |
|---|---|
| Status | Completed |
| Phase | Phase 2 |
| Sponsor | Novo Nordisk A/S |
| Enrollment | 698 participants |
| Design | Interventional, Randomized, Parallel, Masking: Quadruple |
| Conditions | Non-alcoholic Steatohepatitis |
| Interventions | NNC0194 0499 50 mg/mL; Placebo (NNC0194-0499); Semaglutide 3 mg/mL; Semaglutide placebo; NNC0174 0833 10 mg/mL; NNC0174 0833 placebo |
| Start | Aug 31, 2021 |
| Primary completion | Dec 17, 2024 |
| Study completion | Mar 14, 2025 |
| Results posted | Not yet |
| Registry last updated | Nov 19, 2025 |
Compounds on this site that cite this trial
What the registry says the trial is about
This study is being done to see if a combination of 2 medicines (called NNC0194-0499 and semaglutide) can reduce liver damage in patients with non alcoholic steatohepatitis (NASH).
NNC0194-0499 is a new medicine which works in the liver. Semaglutide is a well-known medicine, which is already used by doctors to treat type 2 diabetes in many countries. It also helps with weight loss and may reduce liver damage, and so prevent future liver complications. It works in a different way to NNC0194 0499. The 2 medicines may work better together than on their own.
The study will also look at a combination of semaglutide and another weight-loss medicine called NNC0174-0833, which may be another treatment option for NASH.
Each week, participants will get 2 injections. These could be 2 of the 3 medicines OR 1 of the medicines and a placebo OR 2 placebo injections. Which treatment participants get is decided by chance. A placebo is a dummy medicine which looks like the real medicine but doesn't contain any active medicine.
The study will last for about 19 months. Participants will have 14 clinic visits and 9 phone calls with the study doctor.
Participants will have 1 or 2 liver biopsies (tiny pieces of liver tissue) - one at the start (if participants have not had a biopsy recently) and one at the end of the study treatment.
Women: Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period.
Primary outcomes
These are what the trial was designed to measure first. They are registered in advance, which is what makes a later result checkable.
| Outcome measure | Time frame |
|---|---|
| Improvement in liver fibrosis and no worsening of NASH (Yes/No) | From baseline (week 0) to week 52 |
24 secondary outcomes also registered. See the registry record for the full list.
Source: ClinicalTrials.gov (U.S. National Library of Medicine). Last checked against the registry on Oct 3, 2026. See the trial changes feed for what has changed recently.
