Health Trials

About this trial

This randomized, double-blind, placebo-controlled Phase II study evaluates whether daily subcutaneous tesamorelin (a growth hormone-releasing hormone analog) reduces liver fat in adults with fatty liver disease. 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). Key safety monitoring includes glucose metrics and IGF-1.

Eligibility criteria

Qualifiers

Adults age 18 to 75 years, able to provide informed consent.

Evidence of hepatic steatosis consistent with MASLD/NAFLD, defined as MRI-PDFF >=10% at screening (or equivalent imaging documentation if MRI-PDFF was performed within the prior 8 weeks).

Fibrosis risk compatible with non-cirrhotic disease (e.g., FibroScan liver stiffness below a prespecified threshold and no clinical evidence of portal hypertension).

Stable body weight (+/-5%) for at least 3 months prior to screening.

Disqualifiers

Significant alcohol consumption consistent with alcohol-associated liver disease (e.g., >20 g/day for women or >30 g/day for men for sustained periods).

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.

Poorly controlled diabetes or conditions increasing ocular risk (e.g., HbA1c at or above a protocol threshold; active/untreated diabetic retinopathy).

Trial design

Treatments tested in this trial

  • Tesamorelin
  • Placebo
  • Standardized lifestyle counseling

Treatment groups

120 Participants
are divided into 2 treatment groups

Locations

1
Peking University Shenzhen Hospital518036, ShenzhenGuangdong, China

Sponsors and collaborators

Hudson Biotech

Lead sponsor

Source ClinicalTrials.gov