LiFT Study

LiFT Study

 

What is the purpose of the LiFT study?

The purpose of this study is to see if the study drug lowers fat levels in the liver for men with a type of fatty liver (called non-alcoholic steatohepatitis, or NASH) and lower testosterone levels (called hypogonadism). This study also will look at samples of your liver from a liver biopsy to see if the study drug improves overall liver health, including liver fat, scarring, and swelling.

Who can participate in the LiFT study?

You may qualify for the study, if you meet the below requirements:
  • Male, 18 to 80 years of age
  • Diagnosed with both NASH and lower testosterone (hypogonadism), OR
  • At risk for developing NASH and currently have lower testosterone levels
  • Willing to stop taking testosterone or androgen therapy and Vitamin E before and during the study
Other requirements will apply.

What can study participants expect?

If you meet study requirements and decide to join the LiFT study, your participation will last up to 57 weeks. During this time, you will go through some or all of the below periods, and be asked to do the following:
Washout Period (up to 12 weeks): If you already take androgen replacement therapy, you must stop taking it for up to 12 weeks before and during the study.

Screening Period (4 to 8 weeks): You will have study assessments to confirm you qualify to participate. These may include blood tests, liver scans, a liver ultrasound, and a liver biopsy. 

Study Therapy Period (36 weeks): You will be randomly assigned by computer to take 1 of 2 doses of the study drug or placebo. Placebo looks like the study drug but does not have any active ingredients. You will also visit the study clinic multiple times. 

Follow-up Period: You will have 1 follow-up visit 2 weeks after your last dose of study therapy.
 

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