NCT03375788

Growth Hormone Releasing Hormone Analog to Improve Nonalcoholic Fatty Liver Disease and Associated Cardiovascular Risk

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Non-Alcoholic Fatty Liver Disease
• Obesity
• Obesity, Abdominal
• Liver Fat
• Fatty Liver

Interventions

Type	Name	Description
DRUG	Tesamorelin	Tesamorelin F4 formulation 1.4mg daily
DRUG	Identical Placebo	Placebo injection daily

Timeline

• Start date: 2019-01-17
• Primary completion: 2024-07-10
• Completion: 2025-01-10
• First posted: 2017-12-18
• Last updated: 2025-11-20
• Results posted: 2025-11-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study