The Impact of Ibutamoren on Nonalcoholic Fatty Liver Disease

Study Overview
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Brief Summary
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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).

Official Title
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The Impact of Ibutamoren on Nonalcoholic Fatty Liver Disease: A Pilot Study

Conditions
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NAFLD, Nonalcoholic Fatty Liver, NASH - Nonalcoholic Steatohepatitis

Intervention / Treatment
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* Drug: LUM-201


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 21-60yo and generally healthy BMI ≥ 25 kg/m2 Radiographic or histologic diagnosis of NAFLD / NASH Insulin-like growth factor-1 (IGF-1) level <3rd quartile of normal for age Exclusion Criteria: Contraindications to MRI imaging Diabetes mellitus or use of diabetes medications History of cancer, significant renal disease, decompensated or unstable cardiovascular disease Cirrhosis or known liver disease other than NAFLD Pregnancy or breastfeeding Known pituitary or hypothalamic disease affecting the growth hormone axis Chronic use of drugs causing hepatic steatosis in the past 12 months (chronic oral steroids, methotrexate, tamoxifen) Treatment with medications that may interact with LUM-201 (ibutamoren mesylate)

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Open-label study with historical controls.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Open-label Treatment<br>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. | Drug: LUM-201<br>* LUM-201 (ibutamoren mesylate) is an oral growth hormone secretagogue.<br>* Other names: Ibutamoren Mesylate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intrahepatic lipid content (IHL, %) | Change in intrahepatic lipid content (IHL, %) as measured by proton magnetic resonance spectroscopy (1H-MRS). | 6 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hepatic inflammation and fibrosis by LiverMultiScan corrected T1 (cT1) score | Change in hepatic inflammation and fibrosis by LiverMultiScan cT1. Higher values indicate more severe combined inflammation and fibrosis (normal range 633-794 ms) | 6 Months | 
| Alanine aminotransferase (ALT) | Change in ALT | 6 Months |