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Tesamorelin for Reduction of Liver Fat in Adults With Fatty Liver Disease (Mock Study)
Sponsor: Hudson Biotech
Summary
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.
Official title: 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)
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2026-02-02
Completion Date
2028-02-17
Last Updated
2026-03-19
Healthy Volunteers
No
Interventions
Tesamorelin
for injection, 2 mg SC once daily; participant self-administration after training. Dose may be reduced to 1 mg daily if IGF-1 z-score meets protocol threshold.
Placebo
for injection (mannitol-based, identical appearance), SC once daily.
Standardized lifestyle counseling
dietary guidance and physical activity recommendations,delivered at baseline and reinforced at each visit.
Locations (1)
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China