Could a weekly shot help more people donate part of their liver?
NCT ID NCT07718126
First seen Jul 21, 2026 · Last updated Jul 22, 2026 · Updated 1 time
Summary
This study tests whether a 12-week program combining a weekly injection of mazdutide (a drug that targets gut hormones) with lifestyle counseling can quickly reduce liver fat in overweight or obese people who want to donate part of their liver but are temporarily disqualified due to fatty liver disease. Participants are randomly assigned to receive either mazdutide or a placebo, plus standard lifestyle advice. The main goal is to see if more people in the mazdutide group achieve complete resolution of liver fat without worsening liver damage, potentially allowing them to safely proceed with donation.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a novel GLP-1/GCG receptor dual agonist called mazdutide, given as a weekly injection
- What this could lead to
- If successful, this approach could help more people with fatty liver disease become eligible to donate a portion of their liver, expanding the donor pool and improving outcomes for transplant recipients.
- What could go wrong
- This is an early-to-mid-stage trial with only 60 participants, so results may not apply broadly. The drug can cause gastrointestinal side effects, and not all participants may achieve the desired liver fat reduction.
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 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Aug 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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 60 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: * Age between 18 and 60 years old at the time of signing the informed consent form. * Overweight, defined as Body Mass Index (BMI) ≥ 24 kg/m². * Diagnosed with MASLD by non-invasive means (conventional ultrasound, FibroScan®, or MRI), with a Controlled Attenuation Parameter (CAP) ≥ 268 dB/m via FibroScan®. * Histologically confirmed MASLD without any liver fibrosis, presenting a NAS ≥ 3, including a steatosis subscore ≥ 2 (subscores for hepatocyte ballooning and lobular inflammation are not limited). * Meets ethical and legal regulations, voluntarily donates a portion of the liver, and the corresponding potential liver transplant recipient must be a spouse or a direct or collateral blood relative within three generations. * Understands all procedures and follow-up requirements of the study, participates voluntarily, and signs the written informed consent form in person. Exclusion Criteria: * Liver biopsy indicates complication with any degree of liver fibrosis. * Failure to diagnose overweight or MASLD by non-invasive means, including BMI \< 24 kg/m² and/or CAP \< 268 dB/m. * Histological evaluation shows a total NAS \< 3 and/or a steatosis subscore \< 2. * Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \> 5 × upper limit of normal (ULN) at screening, and/or ALT or AST levels increase by more than 1 fold compared to baseline during screening, which is considered clinically significant by the investigator. * Total bilirubin (TBil) \> 25.6 μmol/L (1.5 mg/dL), and/or alkaline phosphatase (ALP) \> 2 × ULN, and/or International Normalized Ratio (INR) \> 1.35 at screening. * Platelet count \< 150,000/μL at screening, unless considered by the investigator to reflect the patient's daily baseline level and portal hypertension is absent. * Estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73m² based on the CKD-EPI formula at screening. * Glycated hemoglobin (HbA1c) \> 9.5% at screening. * Unstable weight, defined as self-reported weight change \> 5% within 90 days prior to screening up to the time of screening. * Presence of other clearly defined etiologies causing chronic liver disease (non-NAFLD), including positive HBsAg, positive anti-HIV, or positive HCV RNA at screening, or a known history of HCV RNA or HBsAg positivity within 2 years prior to screening. * Presence or history of ascites, variceal bleeding, hepatic encephalopathy, spontaneous bacterial peritonitis, hepatocellular carcinoma, or liver transplantation at screening and randomization. * Presence or history of malignant tumors within 5 years (except basal cell carcinoma, squamous cell skin cancer, and any carcinoma in situ). * Personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN2). * History of acute pancreatitis within 180 days prior to screening, or a history of chronic pancreatitis. * Presence or history of gastroparesis, severe gastroesophageal reflux disease, or prior bariatric surgery at screening and randomization. * History or presence of type 1 diabetes. * Occurrence of myocardial infarction, stroke, NYHA class IV heart failure, hospitalization due to unstable angina, or transient ischemic attack within 90 days prior to screening or during the screening-to-randomization window. * Type 2 diabetes accompanied by uncontrolled and potentially unstable diabetic retinopathy or maculopathy. * History of severe depression, suicidal ideation, or recent suicide attempts. * Known or suspected allergy to the active ingredients or any excipients of the study drug. * Females who are pregnant, lactating, planning a pregnancy, or of childbearing potential but not utilizing highly effective contraceptive methods. * Participation in any approved or unapproved investigational drug clinical trial within 180 days prior to screening (defined as exposure to the investigational drug and inclusive of any post-treatment follow-up period). * Prior participation in this trial (defined as having already undergone randomization). * Known or suspected excessive alcohol consumption (females \> 20g/day, males \> 30g/day) or presence of alcohol dependence. * Use of any GLP-1 receptor agonist (GLP-1RA) within 90 days prior to screening. * Receipt of glucose-lowering drugs (except GLP-1RA), lipid-lowering drugs, or weight-loss drugs considered by the investigator to be at unstable doses within 90 days prior to screening. * Any condition considered by the investigator to render the participant unsuitable for liver donation, or diseases/conditions that may compromise participant safety, pose safety hazards from substantial weight loss, or affect compliance with the protocol. * The recipient designated to receive the liver graft is not a spouse or a direct or collateral blood relative within three generations, or the donation violates ethical, moral, legal, or regulatory codes.
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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
3 sites. 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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Anhui Provincial Hospital (The First Affiliated Hospital of USTC)
Hefei, Anhui, 230036, China
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Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050, China
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West China Hospital, Sichuan University
Chengdu, Sichuan, 610041, China
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Other studies related to the condition(s) this trial covers.
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