RecruitingPhase 2NCT07481734

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

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)


Sponsor

Hudson Biotech

Enrollment

120 participants

Start Date

Feb 2, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Placebo, a behavioral approach called Standardized lifestyle counseling, and others for people with hepatic steatosis, metabolic-associated steatotic liver disease, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTesamorelin

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.

DRUGPlacebo

for injection (mannitol-based, identical appearance), SC once daily.

BEHAVIORALStandardized 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

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NCT07481734


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