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

What Was Tested

In this phase 2 trial, researchers set out to test Tesamorelin for fatty liver & elevated liver enzymes.

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.

It had two arms (groups): Tesamorelin (experimental) and Placebo (placebo comparator).

Identical placebo given subcutaneously daily.

The registry classes the interventions as drug.

Who Took Part

The registry lists 51 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Men and women 18-65yo. Body mass index (BMI) ≥ 30kg/m2, or, for participants with known steatohepatitis, BMI ≥ 25kg/m2. For females ≥50yo, negative mammogram within 1 year of baseline.

The full record lists 7 inclusion and 25 exclusion criteria; among the exclusions: chronic systemic corticosteroid use in the ≤6 months prior to the baseline visit; chronic use of actigall, methotrexate, amiodarone, or tamoxifen; known diagnosis of alpha-1 antitrypsin deficiency, wilson's disease, hemochromatosis, or autoimmune hepatitis.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

Random assignment meant chance, not the researchers, decided who got Tesamorelin and who got the comparison, which limits bias.

Groups ran in parallel: each of the fatty liver & elevated liver enzymes participants stayed in one arm throughout.

Neither the fatty liver & elevated liver enzymes participants nor the staff measuring them knew who was on Tesamorelin, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2019-01-17 with completion listed for 2024-07-10.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Liver Fat Content (time frame: change from baseline to 12 months).

It also tracked 4 secondary outcomes, for example NAFLD Activity Score, Low Density Lipoprotein (LDL) Cholesterol, C-reactive Protein and Fibrosis Score.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Tesamorelin in 51 people with fatty liver & elevated liver enzymes.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Tesamorelin compound page, Fatty liver & elevated liver enzymes research.