New drug shows promise in shrinking fatty liver
NCT ID NCT07481734
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a daily injection of tesamorelin can safely reduce liver fat in adults with metabolic fatty liver disease (MASLD). About 120 participants will receive either the drug or a placebo for 52 weeks, along with lifestyle advice. The main goal is to measure changes in liver fat using MRI scans.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 120 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2026
- Expected to finish
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Feb 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Peking University Shenzhen Hospital
RECRUITINGShenzhen, Guangdong, 518036, China
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