Novo Nordisk A/S is testing semaglutide for non-alcoholic steatohepatitis

 

Semaglutide is a medicine studied in patients with NASH. Semaglutide is a well-known medicine, which is already used by doctors to treat type 2 diabetes in many countries. Participants will either get semaglutide or a dummy medicine - which treatment participants get is decided by chance. Participants will need to inject themselves with medicine under the skin. Participants will need to do this once a week. The study will last for about 5 years. Participants will have up to 21 clinic visits and up to 9 phone calls with the clinical staff during the study. Some of the clinic visits may be spread over more than one day. Women cannot take part in the study if they are pregnant, breast-feeding or plan to become pregnant during the study period.

Sponsor staff involved in the clinical trial is masked according to company standard procedures The trial has two parts, a part 1 and a part 2, in part 2 sponsor will be unblinded.

The researchers plan that April 1, 2021 will be the study start date. The indicative completion of the clinical trial will be expected in May 26, 2028.

Among primary outcome measures are the Part 1: Improvement in liver fibrosis and no worsening of steatohepatitis (Yes/No) and Count of subjects ( Improvement in fibrosis is defined as greater than or equal to 1 grade improvement on the NASH CRN fibrosis scale. No worsening of steatohepatitis is defined as no increase from baseline in NAS score for ballooning, inflammation, or steatosis. ).

The page dedicated to this clinical trial that contains inclusion and exclusion criteria and study locations can be found here: https://ichgcp.net/clinical-trials-registry/NCT04822181.