ClinicalTrials.gg
RecruitingNCT07718126PRIMEUpdated Sep 23, 2026

Pre-hepatectomy Rehabilitation in Obese MASLD-Complicated Living Liver Donors With Mazdutide (PRIME)

A Phase 4 interventional study of Mazdutide and Placebo (Normal Saline) in Metabolic Dysfunction-Associated Steatohepatitis, Hepatic Steatosis and Living Liver Donors, sponsored by West China Hospital. Recruiting at 4 sites in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-09-23.

Sponsored by West China Hospital · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Started Sep 2026; still recruiting 2 months later.
Phase
Phase 4
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

The purpose of this study is to evaluate the efficacy and safety of a short-term (12-week) prehabilitation strategy combining mazdutide (a novel GLP-1/GCG receptor dual agonist) with lifestyle optimization, compared to lifestyle optimization alone, in potential living liver transplantation donors with metabolic dysfunction-associated steatohepatitis (MASLD).

Overweight or obese individuals who intend to donate a portion of their liver but are temporarily disqualified due to hepatic steatosis will be recruited across multiple clinical centers. Participants will be randomly assigned in a 1:1 ratio to either the experimental group (mazdutide subcutaneous injection once weekly plus standardized lifestyle counseling) or the control group (placebo subcutaneous injection once weekly plus standardized lifestyle counseling).

The primary objective is to determine whether the short-term addition of mazdutide can significantly increase the proportion of donors achieving histological resolution of hepatic steatosis without the worsening of fibrosis within 12 weeks. The study ultimately aims to provide high-quality evidence for a rapid, safe, and effective surgical prehabilitation protocol to expand the living donor pool and optimize perioperative outcomes for both donors and recipients.

Read the detailed description

Background and Rationale:

Hepatic steatosis significantly elevates perioperative complications in major abdominal surgeries. In living donor liver transplantation (LDLT), macrovesicular steatosis exceeding 30% renders potential donors ineligible due to severe ischemia-reperfusion injury risks in recipients and impaired remnant liver regeneration in donors. Traditional prehabilitation strategies relying solely on lifestyle changes or low-calorie diets often fail to achieve satisfactory histological reversal within the critical, time-sensitive pre-operative window. Mazdutide, a dual agonist of GLP-1 and glucagon (GCG) receptors, has demonstrated powerful synergistic effects in rapid weight reduction and rapid hepatic fat clearance by simultaneously suppressing appetite and activating hepatic lipolysis. This trial aims to validate whether short-term mazdutide intervention can serve as an aggressive prehabilitation tool to accelerate donor downstaging.

Study Design and Procedures:

This is a prospective, multicenter, randomized, double-blind, placebo-controlled, parallel-group trial conducted in major transplant centers. The study consists of two parts: Part 1 spans from screening to the liver procurement surgery (up to 24 weeks), and Part 2 covers post-operative follow-up up to 1 year.

Potential donors will undergo a rigorous two-step screening process:

  1. Non-invasive screening: Assessment of body mass index (BMI >= 24 kg/m²) and controlled attenuation parameter via FibroScan (CAP >= 268 dB/m).
  2. Histological confirmation: A baseline liver biopsy (Liver Biopsy 1) demonstrating MASLD with a NAFLD Activity Score (NAS) >= 3 and a steatosis subscore >= 2, strictly excluding any degree of liver fibrosis.

Eligible participants will be randomized (1:1) into:

  • Experimental Group (GG Group): Mazdutide subcutaneous injections once weekly, following a dose-escalation regimen: 2mg for Weeks 1-2, 4mg for Weeks 3-4, and a target dose of 6mg from Week 5 to Week 12.
  • Control Group (LL Group): Matching placebo injections once weekly. Both groups will receive identical, standardized counseling on an energy-restricted diet (deficit of 500-750 kcal/day, total intake \<= 1500 kcal/day) and structured physical exercise (>= 150 minutes/week of moderate-to-high intensity sport). Compliance will be monitored via electronic diaries and smart wearable fitness trackers.

Efficacy and Safety Endpoints:

At Week 12 (or earlier if triggered by regular FibroScan text assessments indicating steatosis resolution), a second liver biopsy (Liver Biopsy 2) and abdominal magnetic resonance imaging proton density fat fraction (MRI-PDFF) will be completed to evaluate the primary endpoint: resolution of hepatic steatosis without worsening of MASLD.

For donors successfully meeting the transplantation criteria, a mandatory 1-week drug washout period will be enforced before surgery to mitigate potential anesthesia risks associated with delayed gastric emptying. On the day of surgery, an ultrasound assessment of gastric volume will be performed prior to anesthesia induction.

Exploratory analysis in Part 2 will dynamically track the remnant liver regeneration rate in donors (via CT volumetry) and early graft function (AST/ALT peaks, TBil, and INR recovery profiles) as well as long-term quality of life (SF-36) in recipients up to 1 year post-transplantation.

02

Conditions studied

  • Metabolic Dysfunction-Associated Steatohepatitis
  • Hepatic Steatosis
  • Living Liver Donors

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Keywords

  • Mazdutide
  • GLP-1/GCG receptor dual agonist
  • Living Donor Liver Transplantation
  • Prehabilitation
  • MASLD
  • Organ Donation
  • Preoperative Weight Loss
03

In context

Fatty Liver

662 studies on the registry are indexed under Fatty Liver; 184 are open to participants now.

This study's planned enrollment of 60 is close to the median of 60 across 431 interventional studies indexed under Fatty Liver.

Browse Fatty Liver studies →

Lead sponsor

West China Hospital is the lead sponsor of 501 studies on the registry; 246 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age between 18 and 60 years old at the time of signing the form.
  • Overweight, defined as (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®.
  • 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

Exclusion Criteria:

  • Liver indicates complication with any degree of liver fibrosis.
  • Failure to diagnose overweight or MASLD by non-invasive means, including \< 24 kg/m² and/or CAP \< 268 dB/m.
  • Histological evaluation shows a total NAS \< 3 and/or a steatosis subscore \< 2.
  • (ALT) and/or aspartate aminotransferase (AST) > 5 × (ULN) at screening, and/or ALT or AST levels increase by more than 1 fold compared to baseline during screening, which is considered by the investigator.
  • Total (TBil) > 25.6 μmol/L (1.5 mg/dL), and/or alkaline phosphatase (ALP) > 2 × ULN, and/or (INR) > 1.35 at screening.
  • 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 (eGFR) \< 30 mL/min/1.73m² based on the CKD-EPI formula at screening.
  • (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 , positive anti-, or positive 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, class IV heart failure, hospitalization due to unstable angina, or 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 of the study drug.
  • Females who are pregnant, lactating, planning a pregnancy, or of but not utilizing highly effective methods.
  • Participation in any approved or unapproved 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.
Terms in these criteria, in plain language(21)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    GLP-1/GCG receptor dual agonist plus lifestyle optimization (GG Group)

    Subcutaneous injection of mazdutide once weekly following a 12-week dose-escalation regimen: 2 mg q1w for Weeks 1-2, 4 mg q1w for Weeks 3-4 (if gastrointestinal tolerated), and a target dose of 6 mg q1w from Week 5 to Week 12 (if gastrointestinal tolerated). Standardized lifestyle optimization consists of an energy-restricted diet (deficit of 500-750 kcal/day, total daily intake \<=1500 kcal/day) and structured physical exercise (\>=150 minutes/week of moderate-to-high intensity exercise). A mandatory 1-week drug washout period is enforced prior to surgery.

    Drug: Mazdutide · Behavioral: Lifestyle Optimization

  • Placebo comparator
    Lifestyle optimization only (LL group)

    Subcutaneous injection of a matching placebo once weekly with identical appearance, volume, and injection device for 12 weeks. Standardized lifestyle optimization is identical to the experimental group, consisting of an energy-restricted diet (deficit of 500-750 kcal/day, total daily intake \<=1500 kcal/day) and structured physical exercise (\>=150 minutes/week of moderate-to-high intensity exercise). A matching 1-week placebo washout period is enforced prior to surgery to maintain blinding.

    Drug: Placebo (Normal Saline) · Behavioral: Lifestyle Optimization

Interventions

  • Active drug intervention consisting of a novel GLP-1/GCG receptor dual agonist solution (Mazdutide) administered via subcutaneous injection once weekly using a single-use prefilled automatic injection pen. The dosing schedule follows a 12-week step-up titration regimen starting at 2 mg q1w for Weeks 1-2, increasing to 4 mg q1w for Weeks 3-4 if gastrointestinal tolerated, and reaching a target dose of 6 mg q1w from Week 5 to Week 12 if gastrointestinal tolerated. For participants with intolerable gastrointestinal adverse events, the titration cycle can be prolonged to 3 weeks, or they are permitted to maintain a lower tolerated dose based on multidisciplinary team consensus. To ensure surgical safety, this prehabilitation protocol enforces a mandatory 1-week drug washout period prior to hepatectomy, followed by a preoperative gastric ultrasound assessment by an anesthesiologist to rule out aspiration risks.

  • DrugPlacebo (Normal Saline)

    Inactive comparator intervention consisting of a matching placebo (normal saline) solution administered via subcutaneous injection once weekly. To strictly maintain the double-blind design, the placebo features an identical appearance, volume, and automatic prefilled injection pen delivery device. The administration schedule, dose escalation simulation steps, and the mandatory 1-week pre-operative drug washout period mirror the experimental mazdutide group exactly to maintain the blinding integrity prior to the hepatectomy.

  • BehavioralLifestyle Optimization

    Standardized lifestyle optimization provided to both groups, consisting of an calorie-restricted diet (CRD) and structured physical exercise. The CRD targets a daily calorie deficit of 500 to 750 kcal, with a total daily intake not exceeding 1500 kcal (1000-1200 kcal for females; 1200-1500 kcal for males). The structured exercise requires at least 5 days per week, totaling \>=150 minutes of moderate-to-high intensity aerobic training with a daily energy expenditure \>=150 kcal. Adherence is tracked objectively using a provided smart fitness tracker and daily electronic diaries without mandatory enforcement.

06

What researchers measure

Primary outcomes

  1. Proportion of Participants Achieving Resolution of MASLD Without Worsening of Liver Fibrosis (ROM)

    Percentage of participants who achieve histological resolution of MASLD. Resolution is defined based on the second liver biopsy as a NAFLD Activity Score (NAS) steatosis subscore \<= 1, a hepatocyte ballooning subscore = 0, and a lobular inflammation subscore \<= 1. Additionally, to meet the criteria for resolution, there must be no increase in the total NAS, hepatocyte ballooning, or lobular inflammation subscores, and no worsening of liver fibrosis compared to the baseline liver biopsy.

    Time frame: From randomization (Week 0) to Week 12

Secondary outcomes

  1. Proportion of Participants Achieving Ultrasound-Assessed Improvement of Hepatic Steatosis (uIOS)

    Percentage of participants who achieve improvement of hepatic steatosis evaluated by FibroScan®. Improvement is defined as the Controlled Attenuation Parameter (CAP) dropping to \< 268 dB/m.

    Time frame: From randomization (Week 0) up to Week 12

  2. Proportion of Participants Achieving Imaging-Assessed Improvement of Hepatic Steatosis (iIOS)

    Percentage of participants who achieve improvement of hepatic steatosis evaluated by Magnetic Resonance Imaging (MRI). Improvement is defined as the MRI Proton Density Fat Fraction (MRI-PDFF) dropping to \< 15%.

    Time frame: From randomization (Week 0) up to Week 12

  3. Proportion of Participants Achieving Improvement of MASLD Without Worsening of Liver Fibrosis (IOM)

    Percentage of participants achieving MASLD improvement evaluated by liver biopsy. It is defined as a decrease in the total NAS by \>= 2 or a total NAS \<= 3, with a steatosis subscore \<= 1, while maintaining no increase in subscores for hepatocyte ballooning or lobular inflammation, and no worsening of liver fibrosis.

    Time frame: From randomization (Week 0) up to Week 12

  4. Proportion of Participants Achieving Improvement of Hepatic Steatosis Without Worsening of MASLD (IOS)

    Percentage of participants achieving steatosis improvement evaluated by liver biopsy. It is defined as a decrease in the total NAS by \>= 1 and a NAS steatosis subscore \<= 1, while maintaining no increase in total NAS, hepatocyte ballooning, or lobular inflammation subscores, and no worsening of liver fibrosis.

    Time frame: From randomization (Week 0) up to Week 12

  5. Proportion of Participants Successfully Completing Liver Donation (SCD)

    Percentage of participants who successfully fulfill the clinical criteria for living donor liver transplantation and complete the liver procurement surgery.

    Time frame: From randomization (Week 0) up to Week 24

  6. Percentage Change from Baseline in Body Weight

    Relative change in body weight measured in percentage using calibrated electronic scales under fasting conditions.

    Time frame: From randomization (Week 0) up to Week 12

  7. Percentage Change from Baseline in Body Mass Index (BMI)

    Relative change in BMI calculated as weight in kilograms divided by height in meters squared.

    Time frame: From randomization (Week 0) up to Week 12

  8. Percentage Change from Baseline in Body Fat Percentage

    Relative change in body fat percentage evaluated using the Bioelectrical Impedance Analysis (BIA) method.

    Time frame: From randomization (Week 0) up to Week 12

  9. Percentage Change from Baseline in Visceral Fat Content

    Relative change in visceral fat volume and content quantitatively assessed via abdominal MRI scans.

    Time frame: From randomization (Week 0) up to Week 12

  10. Daily Net Energy Intake During the Treatment Period

    Daily net energy intake calculated based on the total daily energy expenditure estimated by smart fitness trackers minus the daily dietary calorie intake self-reported via electronic questionnaires.

    Time frame: From randomization (Week 0) up to Week 12

  11. Time to Ultrasound-Assessed Hepatic Steatosis Improvement

    The number of days from randomization to the first documentation of hepatic steatosis improvement, defined as a CAP score \< 268 dB/m via regular FibroScan® assessments.

    Time frame: From randomization (Week 0) up to Week 12

  12. Time to Successful Liver Donation

    The number of days from randomization to the date of the successful liver procurement surgery.

    Time frame: From randomization (Week 0) up to Week 24

  13. Change from Baseline in Health-Related Quality of Life (HRQoL) Score

    Change in patient-reported quality of life assessed using the validated Chinese version of the Short Form-36 (SF-36) questionnaire. Total scores range from 0 to 100 for each subscale, with higher scores representing better health status and quality of life.

    Time frame: From randomization (Week 0) up to Week 12

Other outcomes

  1. Peak Serum AST and ALT Levels Post-Hepatectomy

    The maximum serum concentration values of AST and ALT recorded during the donor's post-operative hospitalization period.

    Time frame: From liver procurement surgery up to post-operative Week 2

  2. Time to Serum TBil Normalization Post-Hepatectomy

    The number of days from the liver procurement surgery until the serum total bilirubin level drops back to the normal reference range, defined as \<= 17.1 μmol/L (1 mg/dL).

    Time frame: From liver procurement surgery up to post-operative Week 2

  3. Time to INR Normalization Post-Hepatectomy

    The number of days from the liver procurement surgery until the international normalized ratio (INR) returns to the reference range of 0.8 to 1.5.

    Time frame: From liver procurement surgery up to post-operative Week 2

  4. Remnant Liver Volume After Liver Procurement Surgery

    Absolute volume of the remnant liver measured in mL using multi-slice spiral abdominal contrast-enhanced CT scans.

    Time frame: From liver procurement surgery up to post-operative Week 4

  5. Peak Serum AST and ALT Levels in Recipients Post-Transplantation

    The maximum serum concentration values of AST and ALT recorded in the transplant recipient during their post-operative hospitalization.

    Time frame: From liver transplantation surgery up to post-operative Week 2

  6. Liver Graft Volume in Recipients After Transplantation

    Absolute volume of the transplanted liver graft measured in mL via abdominal contrast-enhanced CT scans.

    Time frame: From liver transplantation surgery up to post-operative Week 4

  7. Time to Serum TBil Normalization in Recipients Post-Transplantation

    The number of days from the transplantation surgery until the recipient's serum total bilirubin drops to the normal reference range (\<= 17.1 μmol/L or 1 mg/dL).

    Time frame: From liver transplantation surgery up to post-operative Week 2

  8. Time to INR Normalization in Recipients Post-Transplantation

    The number of days from the transplantation surgery until the recipient's INR returns to the normal reference range (0.8 to 1.5).

    Time frame: From liver transplantation surgery up to post-operative Week 2

07

Study locations

1 of 4 sites recruiting
  • Anhui Provincial Hospital (The First Affiliated Hospital of USTC)
    Hefei, Anhui 230036, China
    Not yet recruiting
    • Shugeng Zhang, MD · Contactzsg0517@ustc.edu.cn · 8615945965885
    • Shugeng Zhang, MD · Principal investigator
    • Ning Wang, MD · Sub investigator
    • Can Qi, MD · Sub investigator
  • Beijing Friendship Hospital, Capital Medical University
    Beijing, Beijing Municipality 100050, China
    Not yet recruiting
    • Lin Wei, MD · Contactweilin@ccmu.edu.cn · 8618610932626
    • Zhijun Zhu, MD · Principal investigator
    • Lin Wei, MD · Principal investigator
  • The First Affiliated Hospital of Chongqing Medical University
    Chongqing, Chongqing Municipality 400016, China
    Recruiting
    • Jianguo Qiu, MD · Contactqiujianguo456@163.com · 8615703042673
    • Jingyang Gu, MD · Principal investigator
    • Jianguo Qiu, MD · Principal investigator
  • West China Hospital, Sichuan University
    Chengdu, Sichuan 610041, China
    Not yet recruiting
    • Kunlin Xie, MD, PhD · Contactxiekun@scu.edu.cn · 8618980607259
    • Hong Wu, MD · Principal investigator
    • Kunlin Xie, MD · Principal investigator
    • Hongzhao Yang, MBBS · Sub investigator
08

References and documents

Individual participant data

Plan to share: Yes — The data that support the findings of this study are available from the corresponding author upon reasonable request.

Supporting information: Study protocol

Time frame: The data that support the findings of this study are available from the corresponding author upon reasonable request.

Access criteria: The data that support the findings of this study are available from the corresponding author upon reasonable request.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Sep 2026 (actual). Primary completion is estimated for Feb 2029, 29 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 16, 2026
First posted
Jul 21, 2026
StartActual
Sep 1, 2026
Primary completionEst.
Feb 28, 2029
CompletionEst.
Aug 31, 2029
Last update
Sep 23, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07718126
Collaborators
Beijing Friendship Hospital, Anhui Provincial Hospital, First Affiliated Hospital of Chongqing Medical University
Responsible party
Kunlin Xie (Associate professor, West China Hospital) — Principal investigator
First posted
Jul 21, 2026
Start date
Sep 1, 2026
Primary completion
Feb 28, 2029 (estimated)
Completion
Aug 31, 2029 (estimated)
Last update
Sep 23, 2026

Study contacts

Kunlin Xie, MD, PhD
Contact
xiekun@scu.edu.cn
8618980607259

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Mazdutide

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