The Impact of Ibutamoren on Nonalcoholic Fatty Liver Disease: A Pilot Study

• Status: Not yet recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: All

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. We hypothesize that LUM-201 (Ibutamoren mesylate) will decrease intrahepatic lipid accumulation as quantified by proton magnetic resonance spectroscopy (1H-MRS).

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Massachusetts General Hospital

Criteria

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)