Tesamorelin for Reduction of Liver Fat in Adults With Fatty Liver Disease (Mock Study)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHudson Biotech
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 groupsSponsors and collaborators
Source ClinicalTrials.gov