Trial · Interventional
RecruitingPhase 2Registry dataTesamorelin 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
- Ph 2
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.
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)
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).
Change in ALT
Time frame · 52 weeks
Registry description
Clinical chemistry panel at baseline and scheduled visits.
Change in liver stiffness by transient elastography
Time frame · 52 weeks
Registry description
FibroScan liver stiffness measurement; performed per site SOP.
Change in controlled attenuation parameter (CAP) by transient elastography
Time frame · 52 weeks
Registry description
FibroScan CAP measurement
Change in fasting glucose
Time frame · 52 weeks
Change in fasting lipids
Time frame · 52 weeks
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
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