Nonalcoholic fatty liver disease (NAFLD) is common in individuals with obesity and is a significant threat to public health, because it can lead to impaired liver function and liver failure. Growth hormone is a hormone produced in the pituitary gland that helps regulate metabolism and growth. Individuals with obesity, on average, secrete less growth hormone than individuals without obesity. There are data to suggest that growth hormone may help to reduce the amount of fat in the liver, and may also reduce inflammation in the liver, both of which would be helpful to individuals with NAFLD. The purpose of this study is to investigate whether treatment with a drug called tesamorelin, which is a growth hormone releasing hormone analogue, will decrease liver fat and improve liver inflammation and scarring in obese individuals with NAFLD.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
51
Tesamorelin F4 formulation 1.4mg daily
Placebo injection daily
Massachusetts General Hospital
Boston, Massachusetts, United States
Liver Fat Content
Liver Fat Content as measured by hydrogen-magnetic resonance spectroscopy. All available data used; data not available for 1 participant in tesamorelin group and 3 participants in placebo group.
Time frame: change from baseline to 12 months
NAFLD Activity Score
Nonalcoholic Fatty Liver Disease Activity Score (NAS, scored between 0-8, with higher indicating more severe disease) from liver biopsy. All available data used; data not available for 3 participants in placebo group and 1 participant in tesamorelin group.
Time frame: change from baseline to 12 months
Low Density Lipoprotein (LDL) Cholesterol
All available data utilized. Data not available for 2 participants in tesamorelin group and 3 participants in placebo group.
Time frame: change from baseline to 12 months
C-reactive Protein
All available data utilized. Data not available for 2 participants in placebo group.
Time frame: change from baseline to 12 months
Fibrosis Score
fibrosis score from liver biopsy; all available data used - data not available for 1 participant in tesamorelin group and 3 participants in placebo group. Fibrosis stage scored from 0-4, where 0 indicates no fibrosis and 4 indicates most severe fibrosis, which is cirrhosis.
Time frame: change from baseline to 12 months
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