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Sermorelin

GHRH (1-29), GRF 1-29 NH2, Sermorelin acetate

Quick Stats
Studies 223
Trials 41
Completed NA INTERVENTIONAL NCT02196831

Tesamorelin Effects on Liver Fat and Histology in HIV

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

Liver disease is one of the leading co-morbidities of human immunodeficiency virus (HIV) infection, and nonalcoholic fatty liver disease (NAFLD) is present in approximately 30-40% of patients with HIV infection. Nonalcoholic steatohepatitis (NASH) is a more severe form of NAFLD in which increased liver fat is also accompanied by inflammation, cellular damage, and fibrosis. NAFLD is most prevalent in patients who also have increased visceral adiposity, and our group has previously shown that HIV-infected individuals with increased visceral adiposity generally have decreased growth hormone secretion. Tesamorelin is a growth hormone releasing hormone (GHRH) analogue that increases endogenous growth hormone secretion. Tesamorelin is FDA-approved for the reduction of visceral fat in HIV-infected individuals. In a previous study, treatment with tesamorelin in HIV-infected individuals selected for abdominal adiposity reduced liver fat. The current study is designed to test the effect of tesamorelin on liver fat and steatohepatitis in HIV-infected individuals who have NAFLD. The investigators hypothesize that tesamorelin will reduce liver fat and will also ameliorate the inflammation, fibrosis, and hepatocellular damage seen in conjunction with NASH.

Interventions

Name: tesamorelin
Type: DRUG
Description:
Name: Placebo
Type: DRUG
Description: inactive substance that looks like tesamorelin

Primary Outcomes

Measure: Change in Liver Fat as Measured by 1-H Magnetic Resonance Spectroscopy
TimeFrame: change between baseline and 12 months
Description: change (value at 12 months minus value at baseline). Hepatic fat fraction is a standardized measure used to describe the percent fat in the liver. As it is determined by spectroscopy, it is quantified by the area under the lipid peak, standardized to the total area under the (lipid peak + water peak). Using 1-H Magnetic resonance spectroscopy to quantify liver fat in this manner was first described by Longo R et al., Invest Radiol, 1993, 28(4):297-302.

Trial Information

NCT ID

NCT02196831

Status

Completed

Study Type

INTERVENTIONAL

Phases

NA

Sponsor

Massachusetts General Hospital

Last Updated

December 15, 2025

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