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Research study on whether a combination of 2 medicines (NNC0194 0499 and semaglutide) works in people with non-alcoholic steatohepatitis (NASH)


Australia, Belgium, Bulgaria, Canada, Czech Republic, Denmark, France, Germany, Greece, India, Italy, Japan, Malaysia, Netherlands, Poland, Portugal, Russia, Singapore, South Korea, Spain, Taiwan, Turkey, United Kingdom, United States

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NCT number

Eudract number


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.

Trial Overview:


Non-alcoholic steatohepatitis


Drug: NNC0194 0499 50 mg/mL

Drug: Placebo (NNC0194-0499)

Drug: Semaglutide 3 mg/mL

Drug: Semaglutide placebo

Drug: NNC0174 0833 10 mg/mL

Drug: NNC0174 0833 placebo

Study type


Trial duration

Aug 31 2021 - Sep 20 2024

Participation duration

81 Week(s)



Are you eligible?


Male and female


18+ years old

Questions or concerns

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