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

  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)

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

ArmDescriptionAssigned 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.
  • Drug: LUM-201
    LUM-201 (ibutamoren mesylate) is an oral growth hormone secretagogue.
    Other names:
    • Ibutamoren Mesylate

Recruiting Locations

Massachusetts General Hospital
Boston, Massachusetts 02114
Contact:
Laura E Dichtel, MD
617-724-3870
ldichtel@partners.org

More Details

Status
Recruiting
Sponsor
Massachusetts General Hospital

Study Contact

Laura E. Dichtel, MD, MHS
617-726-3870
ldichtel@mgh.harvard.edu