NCT02217345

Growth Hormone and Intrahepatic Lipid Content in Patients With Nonalcoholic Fatty Liver Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 131 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not 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. NAFLD is expected to be the most common indication for liver transplantation by the year 2020. We hypothesize that growth hormone (GH) replacement will decrease intrahepatic lipid accumulation as quantified by 1H magnetic resonance spectroscopy (1H-MRS).

Conditions

• Nonalcoholic Fatty Liver Disease (NAFLD)

Interventions

Type	Name	Description
DRUG	Growth hormone	growth hormone, Genotropin (Pfizer)
DRUG	Placebo	placebo with identical drug pen delivery device and packaging as Genotropin (Pfizer)

Timeline

• Start date: 2017-06-02
• Primary completion: 2021-08-10
• Completion: 2021-09-13
• First posted: 2014-08-15
• Last updated: 2022-11-22
• Results posted: 2022-11-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study