The Impact of Ibutamoren on Nonalcoholic Fatty Liver Disease

Mass General Brigham

Status and phase: Completed; Phase 2

Conditions: Nonalcoholic Fatty Liver; NAFLD; NASH - Nonalcoholic Steatohepatitis

Treatments: Drug: LUM-201

Study type: Interventional

Funder types: Other

Identifiers

NCT05364684

2022P001057

Details and patient eligibility

About

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).

Enrollment: 13 patients

Sex: All

Ages: 21 to 60 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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13 participants in 1 patient group

Open-label Treatment

Other group

Description:

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.

Treatment:

Drug: LUM-201