Tesamorelin for Reduction of Liver Fat in Adults With Fatty Liver Disease (Mock Study)

What Was Tested

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

Participants receive tesamorelin or matching placebo for 52 weeks, with standardized lifestyle counseling in both groups.

Liver fat is quantified by MRI-proton density fat fraction (MRI-PDFF).

It had two arms (groups): one (experimental) and Placebo Comparator: Matching placebo subcutaneous once daily (experimental).

The registry classes the interventions as behavioral and drug.

More on the Plan

Fatty liver disease (MASLD/NAFLD) is common and may progress to steatohepatitis and fibrosis.

In this mock protocol, eligible adults with elevated liver fat on MRI-PDFF are randomized 1:1 to tesamorelin or placebo.

Study medication is self-administered once daily by subcutaneous injection.

Participants complete study visits at baseline and at weeks 4, 12, 24, 36, and 52 (end of treatment), plus a safety follow-up at week 56.

Who Took Part

Enrollment: 120 planned participants were the target.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: Adults age 18 to 75 years, able to provide informed consent. Fibrosis risk compatible with non-cirrhotic disease (e.g., FibroScan liver stiffness below a prespecified threshold and no clinical evidence of portal hypertension). If on diabetes, lipid-lowering, antihypertensive, or weight-loss medications, regimen is stable for at least 3 months prior to screening and expected to remain stable through week 52. Willingness and ability to self-administer daily subcutaneous injections (or have a trained caregiver).

The full record lists 7 inclusion and 11 exclusion criteria; among the exclusions: other chronic liver diseases (e.g., chronic hepatitis b, chronic hepatitis c with viremia, autoimmune hepatitis, wilson disease, hemochromatosis, alpha-1 antitrypsin deficiency); known cirrhosis or decompensated liver disease; or biopsy-proven stage 4 fibrosis if baseline biopsy is performed; use of exogenous growth hormone or ghrh analogs within the past 12 months.

How the Study Was Run

The set-up was randomized, parallel-group and single-blind.

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

The Tesamorelin group and the comparison group ran side by side rather than switching.

Only one side, usually the fatty liver & elevated liver enzymes participants, was kept unaware of whether Tesamorelin was given.

Those kept unaware of assignments: participant.

It started in 2026-02-02 with completion listed for 2027-02-14.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change from baseline in hepatic fat fraction by MRI-PDFF (percentage points) (time frame: 52 weeks).

It also tracked 7 secondary outcomes, for example Change in ALT, Change in liver stiffness by transient elastography, Change in controlled attenuation parameter (CAP) by transient elastography, Change in fasting glucose, Change in fasting lipids and Change in visceral adipose tissue (VAT) volume.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Tesamorelin in 120 people with fatty liver & elevated liver enzymes.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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