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A Phase 2, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled Study Evaluating the Safety and Efficacy of Semaglutide, and the Fixed-Dose Combination of Cilofexor and Firsocostat, Alone and in Combination, in Subjects with Compensated Cirrhosis

Clinical Trial Details

This study is for men and women who have been diagnosed with liver cirrhosis due to Nonalcoholic Steatohepatitis (NASH). This study will test the following experimental/investigational drugs: an injectable named semaglutide and a fixed-dose combination tablet named cilofexor/firsocostat (CILO/FIR) for NASH. 

The investigational drug CILO/FIR has not been approved for the treatment of NASH by the U.S Food and Drug Administration (FDA). Semaglutide is currently approved by the FDA for the treatment of Type 2 Diabetes, but not to treat NASH.
   
NASH is a more severe form of nonalcoholic fatty liver disease (NAFLD) in which the liver becomes fatty, inflamed and liver cells become injured. Over time, scar tissue (fibrosis) forms in the liver. When enough scarring is present, the liver is considered cirrhotic. A cirrhotic liver is unable to perform its normal functions and is at risk for failing.

Participants will be randomized into one of four study groups. Randomization is like flipping a coin and there is an equal chance of being assigned to each group. 

The four groups will receive the following:    

  • Group A: Semaglutide injection and CILO/FIR tablet
  • Group B: Semaglutide injection and placebo CILO/FIR tablet
  • Group C: Placebo semaglutide injection and CILO/FIR tablet
  • Group D: Placebo semaglutide injection and placebo CILO/FIR tablet 

The placebo tablet will look like CILO/FIR tablet or semaglutide but will not contain active medicine/ingredients.
   
Taking part in this study will last approximately 77 weeks, which includes 72 weeks of taking the study drug(s) and a 5-week follow-up period. Participants will be compensated for their time. 

Key Eligibility: 
  1. Men and women who are 18 years of age and older.
  2. Have been diagnosed with liver cirrhosis due to NASH.

Detailed eligibility reviewed when you contact the study team. 



Study contact by location

Upper East Side - Manhattan

Contact(s)

GI/ Hepatology
646-962-5483
GIHepResearch@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

2202024397

ClinicalTrials.gov:

NCT04971785

Sponsor:

GS-US-454-6075

Status

Open to Enrollment

Age Group

Adult

Sponsor