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Efficacy and safety investigation of NNC0194-0499 co-administered with semaglutide in subjects with non-alcoholic steatohepatitis: a dose-ranging placebo-controlled trial

Clinical Trial Details

This study is to see if the experimental drug combinations, NNC0194-0499 and Semaglutide, or NNC0174-0833 and Semaglutide, can reduce liver damage in patients with NASH. NASH is a disease where fat, inflammation and scar tissue build up in the liver. 
 An investigational/experimental drug is one that is currently being tested and has not been approved by the Food and Drug Administration (FDA).
 Semaglutide is already approved to treat patients with type 2 diabetes in many countries, but has not been approved to treat individuals with NASH. Semaglutide is also used as an investigational/experimental drug in research studies of patients with obesity and of patients with different stages of NASH. 

This study is being conducted to see if the study drug Semaglutide can improve liver damage and reduce the risk of medical events related to the liver in individuals with NASH.
NNC0174-0833 is similar to a hormone called amylin that is naturally made in your body. NNC0174-0833 acts like the body’s own hormone which helps your stomach to feel fuller. There is a potential for weight loss if you feel full. Due to this, NNC0174-0833 is being investigated for possible weight-loss, both on its own and when given with semaglutide. Weight loss may have a positive effect on NASH.
NNC0194-0499 is similar to a hormone called fibroblast growth factor 21 (FGF21) that is naturally made in your body. FGF21 works by increasing removal of fat from the blood, removing fat from the liver, decreasing scarring in your liver, and possibly decreasing inflammation in your liver. NNC0194-0499 is expected to have similar effects to the body’s own FGF21. These effects may be beneficial in treating NASH.
Participants will be randomized into one of ten study groups. Randomization is like flipping a coin and there is an equal chance of being assigned to each group.

Each study group involves receiving a different combination and dose of either NNC0194-0499, NNC0174-0833, semaglutide, or placebo. The placebo will look like the study drugs but will not contain active medicine/ingredients.

Participants cannot choose which study group they are in and neither the participant nor the study doctor will not know whether someone will be taking the active study drug(s) or placebo while on this study.
Participation in this study will last about 19 months and participants will be compensated for their time. 

Key Eligibility: 

   1. Men and women who are 18 years of age or older.
   2. Have been diagnosed with non-alcoholic steatohepatitis (NASH).

Detailed eligibility reviewed when you contact the study team.

Study contact by location

Upper East Side - Manhattan


GI/ Hepatology
(646) 962-4040

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:






Open to Enrollment

Age Group