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

Korábbi kezelés

• Chronic systemic corticosteroids or chronic use of medications known to induce or worsen steatosis or liver injury (e.g., amiodarone, tamoxifen, methotrexate).
• Bariatric surgery within the last 12 months, or planned bariatric surgery during the study period.

Más betegség

• 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.
• Active malignancy or high risk for recurrence judged unsafe by investigators.
• Known hypersensitivity to tesamorelin or formulation excipients (e.g., mannitol).

Laborértékek

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

Egyéb

• Use of exogenous growth hormone or GHRH analogs within the past 12 months.
• Contraindications to MRI (e.g., certain implanted devices) if MRI-PDFF is required.
• Pregnancy or breastfeeding.

• 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.
• 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).
• For participants of childbearing potential: agreement to use reliable contraception during treatment and for 30 days after the last dose; negative pregnancy test at screening and baseline.