The Impact of Ibutamoren on Nonalcoholic Fatty Liver Disease

Massachusetts General Hospital12 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

NAFLD Nonalcoholic Fatty Liver NASH - Nonalcoholic Steatohepatitis

Interventions

Eligibility

Sex: ALLMin age: 21 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age 21-60yo and generally healthy 2. BMI ≥ 25 kg/m2 3. Radiographic or histologic diagnosis of NAFLD / NASH 4. Insulin-like growth factor-1 (IGF-1) level \<3rd quartile of normal for age Exclusion Criteria: 1. Contraindications to MRI imaging 2. Diabetes mellitus or use of diabetes medications 3. History of cancer, significant renal disease, decompensated or unstable cardiovascular disease 4. Cirrhosis or known liver disease other than NAFLD 5. Pregnancy or breastfeeding 6. Known pituitary or hypothalamic disease affecting the growth hormone axis 7. Chronic use of drugs causing hepatic steatosis in the past 12 months (chronic oral steroids, methotrexate, tamoxifen) 8. Treatment with medications that may interact with LUM-201 (ibutamoren mesylate)

Outcomes

Primary Outcomes

Intrahepatic Lipid Content (IHL, Percent Liver Fat)

Change in intrahepatic lipid content (6-month percent liver fat minus baseline percent liver fat) as measured by proton magnetic resonance spectroscopy (1H-MRS). Outcome is presented as change in percent liver fat.

Time frame: 6 Months

Secondary Outcomes

Hepatic Inflammation and Fibrosis by LiverMultiScan Corrected T1 (cT1) Score

Change in hepatic inflammation and fibrosis by LiverMultiScan cT1 (6-month cT1 score minus baseline cT1 score). Outcome is presented as change in cT1 score (ms). Higher values indicate more severe combined inflammation and fibrosis (normal range 633-794 ms).

Time frame: 6 Months

Alanine Aminotransferase (ALT)

Change in ALT (6-month ALT minus baseline ALT). Outcome is presented as change in ALT (U/L).

Time frame: 6 Months

The Impact of Ibutamoren on Nonalcoholic Fatty Liver Disease

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes