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The Effect of Semaglutide in Subjects with Non-Cirrhotic Non-Alcoholic Steatohepatitis

Clinical Trial Details

This is a study evaluating the safety and efficacy of the study drug Semaglutide in subjects with non-alcoholic steatohepatitis (NASH). An investigational/experimental drug is one that is currently being tested and has not been approved by the Food and Drug Administration (FDA) for sale in the United States. Experimental drugs such as Semaglutide may be tested in research studies such as this one.
   
NASH is a disease where fat, inflammation and scar tissue build up in the liver. We are conducting this research study to see if Semaglutide can help individuals with NASH get better and reduce their risk of future liver complications. Semaglutide may improve these liver damages, which might make it possible to prevent future liver complications.
   
Semaglutide is already used by doctors to treat patients with type 2 diabetes in many countries. It is also used 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.
   
There are two study drugs: Semaglutide and placebo being used in this study. The placebo tablet will look like Semaglutide but will not contain active medicine/ingredients.  If an individual agrees to participate and meets all the requirements, individuals will be randomized (chosen by chance) to one of several study groups with different drug dosages. Participants and the study doctor will not know whether you have been assigned to Semaglutide or the placebo. If there is a medical emergency and it is important to know what study drug has been assigned, this information can be given to the study doctor by the sponsor.     

Participation in this study will last about 5 years.
   
 Participants will be compensated for their time. 

Key Eligibility: 
  1. Men and women who are above or equal to 18 years of age.
  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

Contact(s)

GI/ Hepatology
(646) 962-4040
GIHepResearch@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

2012023015

ClinicalTrials.gov:

NCT04822181

Sponsor:

NN9931-4553

Status

Open to Enrollment

Age Group

Adult

Sponsor