Ibutamoren for Nonalcoholic Fatty Liver Disease

Recruiting in Palo Alto (17 mi)

Overseen byLaura E Dichtel, MD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Massachusetts General Hospital

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?Nonalcoholic fatty liver disease (NAFLD), fatty infiltration of the liver in the absence of alcohol use, is an increasingly recognized complication of obesity, with prevalence estimates of about 30% of individuals in the United States. A subset of these will develop progressive disease in the form of nonalcoholic steatohepatitis (NASH), which can progress to cirrhosis and liver failure. The investigators hypothesize that LUM-201 (Ibutamoren mesylate) will decrease intrahepatic lipid accumulation as quantified by proton magnetic resonance spectroscopy (1H-MRS).

Eligibility Criteria

This trial is for adults aged 21-60 with a BMI of at least 25 who have been diagnosed with nonalcoholic fatty liver disease (NAFLD) or nonalcoholic steatohepatitis (NASH), and have lower than normal levels of IGF-1. It's not open to those with diabetes, other liver diseases, pituitary or hypothalamic disorders, recent use of certain drugs that affect the liver, interactions with LUM-201, history of cancer or significant heart/kidney disease, or if pregnant/breastfeeding.

Inclusion Criteria

I have been diagnosed with fatty liver disease or NASH.

BMI ≥ 25 kg/m2

I am between 21 and 60 years old and in good health.

+1 more

Exclusion Criteria

Pregnancy or breastfeeding

I have a condition affecting my pituitary or hypothalamus that impacts growth hormone.

Contraindications to MRI imaging

+5 more

Participant Groups

The trial tests whether Ibutamoren mesylate (LUM-201) can reduce fat in the liver among people without alcohol-related liver issues. The study will measure changes in intrahepatic lipid content using advanced imaging techniques like proton magnetic resonance spectroscopy.

1Treatment groups

Experimental Treatment

Group I: Open-label TreatmentExperimental Treatment1 Intervention

Open-label study of oral LUM-201 (ibutamoren mesylate) 25mg daily in otherwise healthy adults with BMI ≥25 kg/m2 and histologic or radiologic diagnosis of NAFLD.