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Tesamorelin

Egrifta, TH9507

Quick Stats
Studies 64
Trials 24
Completed NA INTERVENTIONAL NCT01263717

Effects of Growth Hormone Releasing Hormone in HIV

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

HIV-infection and its treatment are often associated with an increase in belly fat, as well as abnormal cholesterol and problems metabolizing sugar. People with HIV infection and increased belly fat often have decreased growth hormone (GH) levels. Low GH levels may contribute independently to increased belly fat and to increased cardiovascular risk through effects on sugar metabolism, inflammation, and other mechanisms. Tesamorelin, a growth hormone releasing hormone (GHRH) analogue, has been shown to to reduce belly fat in patients with HIV-associated abdominal fat accumulation. However, the effects of tesamorelin on fat accumulation in the liver and muscle, sugar metabolism, and cardiovascular health are not yet known. The current study is designed to determine the effects of tesamorelin treatment on fat accumulation in the muscle and liver, insulin sensitivity and sugar metabolism, and markers of cardiovascular health including blood vessel thickness (carotid intima media thickness \[cIMT\]) and markers of inflammation in the body. The investigators hypothesize that tesamorelin will decrease fat accumulation in the liver and muscle and will decrease markers of inflammation, with either neutral or beneficial effects on glucose metabolism.

Interventions

Name: tesamorelin
Type: DRUG
Description: Tesamorelin (growth hormone releasing hormone) 2mg daily given by subcutaneous injection x 6 months during randomized phase, followed by 6 months of open-label tesamorelin at same dose
Name: placebo
Type: DRUG
Description: Placebo 2mg daily given by subcutaneous injection for the first 6 months of the study, followed by an open-label phase of 6 months of tesamorelin (growth hormone releasing hormone) treatment, 2mg daily given by subcutaneous injection

Primary Outcomes

Measure: Liver Fat
TimeFrame: 6 months
Description: Hepatic fat as measured by magnetic resonance (MR) spectroscopy, and expressed by normalizing lipid to water and expressing as a percent (lipid-to-water percent).
Measure: Visceral Adipose Tissue
TimeFrame: 6 months
Description: Change in visceral adipose tissue area as measured by single-slice computed tomography (CT) scan at the L4 vertebra.

Trial Information

NCT ID

NCT01263717

Status

Completed

Study Type

INTERVENTIONAL

Phases

NA

Sponsor

Massachusetts General Hospital

Last Updated

December 15, 2025

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