The Impact of Ibutamoren on Nonalcoholic Fatty Liver Disease
Purpose
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).
Conditions
- NAFLD
- Nonalcoholic Fatty Liver
- NASH - Nonalcoholic Steatohepatitis
Eligibility
- Eligible Ages
- Between 21 Years and 60 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- 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
- 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)
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Intervention Model Description
- Open-label study with historical controls.
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Other Open-label Treatment |
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. |
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Recruiting Locations
Massachusetts General Hospital
Boston, Massachusetts 02114
Boston, Massachusetts 02114
More Details
- Status
- Recruiting
- Sponsor
- Massachusetts General Hospital