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RECRUITING
NCT07481734
PHASE2

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

Sponsor: Hudson Biotech

View on ClinicalTrials.gov

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

DRUG

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.

DRUG

Placebo

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

BEHAVIORAL

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