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

NCT07481734 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-03-19

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Hudson Biotech

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-02
Primary Completion
2027-02-14
Completion
2028-02-17

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07481734 on ClinicalTrials.gov