Liver Fat Content
| Group | Value (percent change in hepatic fat fraction) |
|---|---|
| Tesamorelin | -5.3 |
| Placebo | 3.6 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataUnited States
1 trial · 1 completed · 1 with posted results
Growth Hormone Releasing Hormone Analog to Improve Nonalcoholic Fatty Liver Disease and Associated Cardiovascular Risk
NCT0337578817 Jan 2019 to 10 Jan 2025
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Experimental
Tesamorelin
tesamorelin (brand name Egrifta) 2mg daily given subcutaneously
Placebo comparator
Placebo
identical placebo given subcutaneously daily
Outcomes the sponsor listed as primary.
Liver Fat Content
Time frame · change from baseline to 12 months
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.
NAFLD Activity Score
Time frame · change from baseline to 12 months
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.
Low Density Lipoprotein (LDL) Cholesterol
Time frame · change from baseline to 12 months
All available data utilized. Data not available for 2 participants in tesamorelin group and 3 participants in placebo group.
C-reactive Protein
Time frame · change from baseline to 12 months
All available data utilized. Data not available for 2 participants in placebo group.
Fibrosis Score
Time frame · change from baseline to 12 months
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.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (percent change in hepatic fat fraction) |
|---|---|
| Tesamorelin | -5.3 |
| Placebo | 3.6 |
| Group | Value (units on a scale) |
|---|---|
| Tesamorelin | 0 |
| Placebo | 0 |
| Group | Value (milligrams per deciliter) | Spread |
|---|---|---|
| Tesamorelin | -5.7 | 27 |
| Placebo | -0.7 | 16 |
| Group | Value (milligrams per liter (mg/L)) | Spread |
|---|---|---|
| Tesamorelin | -0.9 | 4.2 |
| Placebo | 0.0 | 4.1 |
| Group | Value (units on a scale) |
|---|---|
| Tesamorelin | 0 |
| Placebo | 0 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Double-blind Phase: Tesamorelintesamorelin (brand name Egrifta) 2mg daily given subcutaneously for first 12 months Tesamorelin: Tesamorelin F4 formulation 1.4mg daily | 0 / 26 | 2 / 26 | 22 / 26 |
| Double-blind Phase: Placeboidentical placebo given subcutaneously daily for first 12 months Identical Placebo: Placebo injection daily | 0 / 25 | 3 / 25 | 15 / 25 |
| Open Label Phaseall patients receiving open-label tesamorelin from months 12-18 | 0 / 30 | 0 / 30 | 16 / 30 |
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