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Trial · Interventional

RecruitingPhase 2Registry data

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

Short name TESA-LIVER

Overview

Status
Recruiting
Phase
Phase 2
Enrollment
120 participants (estimated)
Sponsor
Hudson Biotech · Industry
Design
Randomized · Single masking
Countries
1 country

China

Start
2 Feb 2026
Primary completion
14 Feb 2027 (estimated)
Completion
17 Feb 2028 (estimated)
First posted
19 Mar 2026
Last update posted
19 Mar 2026
Conditions
Metabolic Associated Steatotic Liver Disease · Nonalcoholic Steatohepatitis · Hepatic Steatosis

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2026202720282029
  1. Ph 2

    TESA-LIVER

    NCT07481734

    2 Feb 2026 to est. 17 Feb 2028

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • TesamorelinDrug
  • PlaceboDrug
  • Standardized lifestyle counselingBehavioral

Arms2

  • Experimental

    Experimental: Tesamorelin 2 mg subcutaneous once daily (with dose-reduction algorithm for elevated I

  • Experimental

    Placebo Comparator: Matching placebo subcutaneous once daily

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change from baseline in hepatic fat fraction by MRI-PDFF (percentage points)

    Time frame · 52 weeks

    Registry description

    MRI-PDFF performed at baseline and week 52; central blinded read.

Secondary outcomes(7)
  1. MRI-PDFF responder rate (>=30% relative decline from baseline)

    Time frame · 52 weeks

    Registry description

    Responder analysis using MRI-PDFF values (baseline vs week 52).

  2. Change in ALT

    Time frame · 52 weeks

    Registry description

    Clinical chemistry panel at baseline and scheduled visits.

  3. Change in liver stiffness by transient elastography

    Time frame · 52 weeks

    Registry description

    FibroScan liver stiffness measurement; performed per site SOP.

  4. Change in controlled attenuation parameter (CAP) by transient elastography

    Time frame · 52 weeks

    Registry description

    FibroScan CAP measurement

  5. Change in fasting glucose

    Time frame · 52 weeks

  6. Change in fasting lipids

    Time frame · 52 weeks

  7. Change in visceral adipose tissue (VAT) volume

    Time frame · 52 weeks

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 75 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Adults age 18 to 75 years, able to provide informed consent. * Evidence of hepatic steatosis consistent with MASLD/NAFLD, defined as MRI-PDFF \>=10% at screening (or equivalent imaging documentation if MRI-PDFF was performed within the prior 8 weeks). * Fibrosis risk compatible with non-cirrhotic disease (e.g., FibroScan liver stiffness below a prespecified threshold and no clinical evidence of portal hypertension). * Stable body weight (+/-5%) for at least 3 months prior to screening. * If on diabetes, lipid-lowering, antihypertensive, or weight-loss medications, regimen is stable for at least 3 months prior to screening and expected to remain stable through week 52. * Willingness and ability to self-administer daily subcutaneous injections (or have a trained caregiver). * For participants of childbearing potential: agreement to use reliable contraception during treatment and for 30 days after the last dose; negative pregnancy test at screening and baseline. Exclusion Criteria: * Significant alcohol consumption consistent with alcohol-associated liver disease (e.g., \>20 g/day for women or \>30 g/day for men for sustained periods). * Other chronic liver diseases (e.g., chronic hepatitis B, chronic hepatitis C with viremia, autoimmune hepatitis, Wilson disease, hemochromatosis, alpha-1 antitrypsin deficiency). * Known cirrhosis or decompensated liver disease; or biopsy-proven stage 4 fibrosis if baseline biopsy is performed. * Poorly controlled diabetes or conditions increasing ocular risk (e.g., HbA1c at or above a protocol threshold; active/untreated diabetic retinopathy). * Use of exogenous growth hormone or GHRH analogs within the past 12 months. * Chronic systemic corticosteroids or chronic use of medications known to induce or worsen steatosis or liver injury (e.g., amiodarone, tamoxifen, methotrexate). * Active malignancy or high risk for recurrence judged unsafe by investigators. * Contraindications to MRI (e.g., certain implanted devices) if MRI-PDFF is required. * Pregnancy or breastfeeding. * Known hypersensitivity to tesamorelin or formulation excipients (e.g., mannitol). * Bariatric surgery within the last 12 months, or planned bariatric surgery during the study period.

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