NCT05364684

The Impact of Ibutamoren on Nonalcoholic Fatty Liver Disease

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 21 Years – 60 Years
• Healthy volunteers: Accepted

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).

Conditions

• NAFLD
• Nonalcoholic Fatty Liver
• NASH - Nonalcoholic Steatohepatitis

Interventions

Type	Name	Description
DRUG	LUM-201	LUM-201 (ibutamoren mesylate) is an oral growth hormone secretagogue.

Timeline

• Start date: 2022-08-10
• Primary completion: 2024-11-22
• Completion: 2024-12-23
• First posted: 2022-05-06
• Last updated: 2026-01-06
• Results posted: 2026-01-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study