Actively Recruiting
Tesamorelin for Reduction of Liver Fat in Adults With Fatty Liver Disease (Mock Study)
Led by Hudson Biotech · Updated on 2026-03-19
120
Participants Needed
1
Research Sites
106 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Tesamorelin for Reduction of Liver Fat in Adults With Fatty Liver Disease (Mock Study)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults age 18 to 75 years able to provide informed consent
- Evidence of hepatic steatosis consistent with MASLD/NAFLD, defined as MRI-PDFF 10% or higher at screening or equivalent imaging within 8 weeks
- Fibrosis risk compatible with non-cirrhotic disease (e.g., FibroScan liver stiffness below threshold, no portal hypertension)
- Stable body weight within 5% for at least 3 months prior to screening
- Stable regimen of diabetes, lipid-lowering, antihypertensive, or weight-loss medications for at least 3 months 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 30 days after last dose; negative pregnancy test at screening and baseline
You will not qualify if you...
- Significant alcohol consumption consistent with alcohol-associated liver disease (more than 20 g/day for women or 30 g/day for men)
- Other chronic liver diseases such as chronic hepatitis B, chronic hepatitis C with viremia, autoimmune hepatitis, Wilson disease, hemochromatosis, alpha-1 antitrypsin deficiency
- Known cirrhosis or decompensated liver disease; biopsy-proven stage 4 fibrosis if baseline biopsy performed
- Poorly controlled diabetes or conditions increasing eye risk (e.g., high HbA1c; active or untreated diabetic retinopathy)
- Use of exogenous growth hormone or GHRH analogs within past 12 months
- Chronic systemic corticosteroids or chronic use of medications that may worsen steatosis or liver injury (e.g., amiodarone, tamoxifen, methotrexate)
- Active cancer or high risk for recurrence considered unsafe by investigators
- Contraindications to MRI if MRI-PDFF is required
- Pregnancy or breastfeeding
- Known allergy to tesamorelin or formulation components (e.g., mannitol)
- Bariatric surgery within last 12 months or planned during study period
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China, 518036
Actively Recruiting
Research Team
S
Seni S Lu, Phd
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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