Tesamorelin to reduce liver fat in adults with fatty liver disease

A Randomized, Double-Blind, Placebo-Controlled Phase II Study of Tesamorelin (GHRH Analog) for Reducing Hepatic Steatosis in Adults With Metabolic Associated Steatotic Liver Disease (MASLD)

This trial tests whether a daily self‑injection of tesamorelin can lower liver fat over 52 weeks in adults with fatty liver disease.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Hudson Biotech (Industry-sponsored)
• Drugs / interventions: methotrexate
• Locations: 1 site (Shenzhen, Guangdong)
• Trial ID: NCT07481734 on ClinicalTrials.gov

What this trial studies

This is a randomized, double‑blind, placebo‑controlled Phase II study in which adults with elevated liver fat are assigned 1:1 to daily subcutaneous tesamorelin or matching placebo for 52 weeks, with standardized lifestyle counseling for all participants. Liver fat is measured by MRI‑proton density fat fraction (MRI‑PDFF) at baseline, week 24, and week 52, and the primary endpoint is change in MRI‑PDFF from baseline to week 52. Key secondary outcomes include the proportion achieving a ≥30% relative decline in MRI‑PDFF, changes in liver enzymes and noninvasive fibrosis measures, and metabolic markers such as glucose, HbA1c, HOMA‑IR, and lipids. Safety monitoring emphasizes glucose metrics and IGF‑1 with dose adjustment rules to handle elevated IGF‑1 while preserving blinding.

Who should consider this trial

Good fit: Adults age 18–75 with MRI‑PDFF ≥10% (or equivalent recent imaging), non‑cirrhotic liver disease, stable weight, and the ability to self‑administer daily subcutaneous injections are ideal candidates.

Not a fit: People with cirrhosis, clinical portal hypertension, unstable weight or medications, pregnancy, or those unable/unwilling to self‑inject may not be expected to benefit from participation.

Why it matters

Potential benefit: If successful, tesamorelin could meaningfully reduce liver fat and improve metabolic risk factors in people with MASLD/NAFLD, potentially slowing progression toward steatohepatitis and fibrosis.

How similar studies have performed: Prior randomized studies of tesamorelin in NAFLD populations have shown reductions in hepatic fat fraction, though larger and longer trials are still needed to define clinical outcomes.

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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).
* Use of exogenous growth hormone or GHRH analogs within the past 12 months.
* Chronic systemic corticosteroids or chronic use of medications known to induce or worsen steatosis or liver injury (e.g., amiodarone, tamoxifen, methotrexate).
* Active malignancy or high risk for recurrence judged unsafe by investigators.
* Contraindications to MRI (e.g., certain implanted devices) if MRI-PDFF is required.
* Pregnancy or breastfeeding.
* Known hypersensitivity to tesamorelin or formulation excipients (e.g., mannitol).
* Bariatric surgery within the last 12 months, or planned bariatric surgery during the study period.

Where this trial is running

Shenzhen, Guangdong

• Peking University Shenzhen Hospital — Shenzhen, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: Seni S Lu, Phd

Conditions Metabolic Associated Steatotic Liver Disease; Nonalcoholic Steatohepatitis; Hepatic Steatosis; Tesamorelin; GHRH analog; growth hormone axis; hepatic fat fraction; MRI-PDFF