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NCT05364684 | Recruiting | NAFLD

The Impact of Ibutamoren on Nonalcoholic Fatty Liver Disease
Sponsor:

Massachusetts General Hospital

Information provided by (Responsible Party):

Laura Dichel, MD

Brief Summary:

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).

Condition or disease

NAFLD

Nonalcoholic Fatty Liver

NASH - Nonalcoholic Steatohepatitis

Intervention/treatment

LUM-201

Phase

Phase 2

Study Type : Interventional
Estimated Enrollment : 12 participants
Masking : None (Open Label)
Primary Purpose : Treatment
Official Title : The Impact of Ibutamoren on Nonalcoholic Fatty Liver Disease: A Pilot Study
Actual Study Start Date : August 10, 2022
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : June 2024
Arm Intervention/treatment

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
Ages Eligible for Study: 21 Years to 60 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Accepts Healthy Volunteers
Criteria
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)
The Impact of Ibutamoren on Nonalcoholic Fatty Liver Disease

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The Impact of Ibutamoren on Nonalcoholic Fatty Liver Disease

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Locations

Recruiting

United States, Massachusetts

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114