Non-Alcoholic Steatohepatitis and Liver Fibrosis Treatment Study

Clinical Trial Title

A phase 2, randomized, double-blind, placebo-controlled, multicenter, dose finding study to evaluate the efficacy and safety of CC-90001 in subjects with non-alcoholic steatohepatitis (NASH) and stage 3 or stage 4 liver fibrosis.

Clinical Trial Protocol Description:

The purpose of this study is to test an experimental study drug called CC-90001. This study will test three different doses of the study medication compared to placebo (a “sugar pill”, an inactive substance that contains no medicine but looks exactly the same). This study is being done to assess response to treatment on measures of liver fibrosis, as well as overall safety of the drug and dose response. Study participants and the study staff will not know whether they are receiving study drug or placebo.

Clinical Trial Eligibility Criteria:

In order to participate you must meet the following criteria: 

  • Are 18 years of age or older.
  • Have a diagnosis of NASH with Stage 3 or Stage 4 fibrosis
  • Have no history of malignancy (exception: cured basal and squamous cell carcinomas).
  • If you have type II diabetes, it must be controlled with hemoglobin A1C < 8.

This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.

Study Details

Clinical Trial Investigator

Nikunj Shah, MD

Contact Information

Mary (Molly) Byrnes