NCT07481734

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)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Hudson Biotech · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Fatty liver disease (MASLD/NAFLD) is common and may progress to steatohepatitis and fibrosis. There are limited pharmacologic options that directly and durably reduce hepatic steatosis while also improving metabolic risk. Tesamorelin is a synthetic analog of growth hormone-releasing hormone (GHRH) that increases endogenous pulsatile growth hormone secretion and can influence lipid metabolism. Prior randomized studies of tesamorelin have shown reductions in hepatic fat fraction in populations with NAFLD, using magnetic-resonance-based quantification and paired histology in subsets. The primary efficacy endpoint is change in liver fat (MRI-PDFF) from baseline to week 52. Secondary endpoints include MRI-PDFF responder rate (\>=30% relative decline), changes in liver enzymes and noninvasive fibrosis measures, metabolic outcomes (glucose, HbA1c, HOMA-IR, lipids), and safety/tolerability outcomes. In this mock protocol, eligible adults with elevated liver fat on MRI-PDFF are randomized 1:1 to tesamorelin or placebo. Study medication is self-administered once daily by subcutaneous injection. Dose reduction rules are included for elevated IGF-1 while preserving the blind. Participants complete study visits at baseline and at weeks 4, 12, 24, 36, and 52 (end of treatment), plus a safety follow-up at week 56. MRI-PDFF is performed at baseline, week 24, and week 52. Transient elastography (FibroScan) and standard laboratory panels are collected at prespecified visits. A voluntary liver-biopsy sub-study is offered to evaluate histologic activity and fibrosis.

Conditions

• Metabolic Associated Steatotic Liver Disease
• Nonalcoholic Steatohepatitis
• Hepatic Steatosis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-02-02
• Primary completion: 2027-02-14
• Completion: 2028-02-17
• First posted: 2026-03-19
• Last updated: 2026-03-19

Locations

1 site across 1 country: China