Ibutamoren for Nonalcoholic Fatty Liver Disease

Overseen By Laura E. Dichtel, MD, MHS

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Massachusetts General Hospital

Must not be taking: Diabetes medications, Oral steroids

Disqualifiers: Diabetes, Cancer, Renal disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

13 Participants Needed

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).

Research Team

Laura E Dichtel, MD

Principal Investigator

Massachusetts General Hospital

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.

Exclusion Criteria

Pregnancy or breastfeeding

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

Contraindications to MRI imaging

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive open-label oral LUM-201 (ibutamoren mesylate) 25mg daily

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Ibutamoren

Trial Overview 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.

Participant Groups

Group I: Open-label Treatment Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+