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

ConditionsMetabolic Associated Steatotic Liver DiseaseNonalcoholic SteatohepatitisHepatic Steatosis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHudson Biotech

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tesamorelin

    Drug

    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.

  • Placebo

    Drug

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

  • Standardized lifestyle counseling

    Behavioral

    dietary guidance and physical activity recommendations,delivered at baseline and reinforced at each visit.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Experimental: Tesamorelin 2 mg subcutaneous once daily (with dose-reduction algorithm for elevated IExperimental treatment 3 interventions
Group B: Placebo Comparator: Matching placebo subcutaneous once dailyExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

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

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

Time frame
52 weeks

Secondary outcomes

1

MRI-PDFF responder rate (>=30% relative decline from baseline)

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

Time frame
52 weeks
2

Change in ALT

Clinical chemistry panel at baseline and scheduled visits.

Time frame
52 weeks
3

Change in liver stiffness by transient elastography

FibroScan liver stiffness measurement; performed per site SOP.

Time frame
52 weeks
4

Change in controlled attenuation parameter (CAP) by transient elastography

FibroScan CAP measurement

Time frame
52 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hudson Biotech

Lead sponsor

Source ClinicalTrials.gov
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