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

16. juli 2026 opdateret af: Kunlin Xie, West China Hospital

Short-term Mazdutide Plus Lifestyle Intervention Versus Placebo for Pre-hepatectomy Prehabilitation in Living Liver Donors With MASLD: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

60

Fase

  • Fase 2
  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Kina
    • Anhui
      • Hefei, Anhui, Kina, 230036
        • Anhui Provincial Hospital (The First Affiliated Hospital of USTC)
        • Underforsker:
          • Ning Wang, MD
        • Kontakt:
        • Ledende efterforsker:
          • Shugeng Zhang, MD
    • Beijing Municipality
      • Beijing, Beijing Municipality, Kina, 100050
        • Beijing Friendship hospital, Capital Medical University
        • Ledende efterforsker:
          • Lin Wei, MD
        • Kontakt:
        • Ledende efterforsker:
          • Zhijun Zhu, MD
    • Sichuan
      • Chengdu, Sichuan, Kina, 610041
        • West China Hospital, Sichuan University
        • Kontakt:
        • Ledende efterforsker:
          • Hong Wu, MD
        • Ledende efterforsker:
          • Kunlin Xie, MD
        • Underforsker:
          • Hongzhao Yang, MBBS

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Medicin: Mazdutide
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.
Adfærdsmæssigt: Lifestyle 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.
Placebo komparator: 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.
Adfærdsmæssigt: Lifestyle 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.
Medicin: Placebo (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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Proportion of Participants Achieving Resolution of MASLD Without Worsening of Liver Fibrosis (ROM)
Tidsramme: From randomization (Week 0) to Week 12
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.
From randomization (Week 0) to Week 12

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Proportion of Participants Achieving Ultrasound-Assessed Improvement of Hepatic Steatosis (uIOS)
Tidsramme: From randomization (Week 0) up to Week 12
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.
From randomization (Week 0) up to Week 12
Proportion of Participants Achieving Imaging-Assessed Improvement of Hepatic Steatosis (iIOS)
Tidsramme: From randomization (Week 0) up to Week 12
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%.
From randomization (Week 0) up to Week 12
Proportion of Participants Achieving Improvement of MASLD Without Worsening of Liver Fibrosis (IOM)
Tidsramme: From randomization (Week 0) up to Week 12
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.
From randomization (Week 0) up to Week 12
Proportion of Participants Achieving Improvement of Hepatic Steatosis Without Worsening of MASLD (IOS)
Tidsramme: From randomization (Week 0) up to Week 12
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.
From randomization (Week 0) up to Week 12
Proportion of Participants Successfully Completing Liver Donation (SCD)
Tidsramme: From randomization (Week 0) up to Week 24
Percentage of participants who successfully fulfill the clinical criteria for living donor liver transplantation and complete the liver procurement surgery.
From randomization (Week 0) up to Week 24
Percentage Change from Baseline in Body Weight
Tidsramme: From randomization (Week 0) up to Week 12
Relative change in body weight measured in percentage using calibrated electronic scales under fasting conditions.
From randomization (Week 0) up to Week 12
Percentage Change from Baseline in Body Mass Index (BMI)
Tidsramme: From randomization (Week 0) up to Week 12
Relative change in BMI calculated as weight in kilograms divided by height in meters squared.
From randomization (Week 0) up to Week 12
Percentage Change from Baseline in Body Fat Percentage
Tidsramme: From randomization (Week 0) up to Week 12
Relative change in body fat percentage evaluated using the Bioelectrical Impedance Analysis (BIA) method.
From randomization (Week 0) up to Week 12
Percentage Change from Baseline in Visceral Fat Content
Tidsramme: From randomization (Week 0) up to Week 12
Relative change in visceral fat volume and content quantitatively assessed via abdominal MRI scans.
From randomization (Week 0) up to Week 12
Daily Net Energy Intake During the Treatment Period
Tidsramme: From randomization (Week 0) up to Week 12
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.
From randomization (Week 0) up to Week 12
Time to Ultrasound-Assessed Hepatic Steatosis Improvement
Tidsramme: From randomization (Week 0) up to Week 12
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.
From randomization (Week 0) up to Week 12
Time to Successful Liver Donation
Tidsramme: From randomization (Week 0) up to Week 24
The number of days from randomization to the date of the successful liver procurement surgery.
From randomization (Week 0) up to Week 24
Change from Baseline in Health-Related Quality of Life (HRQoL) Score
Tidsramme: From randomization (Week 0) up to Week 12
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.
From randomization (Week 0) up to Week 12
Peak Serum AST and ALT Levels Post-Hepatectomy
Tidsramme: From liver procurement surgery up to post-operative Week 2
The maximum serum concentration values of AST and ALT recorded during the donor's post-operative hospitalization period.
From liver procurement surgery up to post-operative Week 2
Time to Serum TBil Normalization Post-Hepatectomy
Tidsramme: From liver procurement surgery up to post-operative Week 2
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).
From liver procurement surgery up to post-operative Week 2
Time to INR Normalization Post-Hepatectomy
Tidsramme: From liver procurement surgery up to post-operative Week 2
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.
From liver procurement surgery up to post-operative Week 2
Remnant Liver Volume After Liver Procurement Surgery
Tidsramme: From liver procurement surgery up to post-operative Week 4
Absolute volume of the remnant liver measured in mL using multi-slice spiral abdominal contrast-enhanced CT scans.
From liver procurement surgery up to post-operative Week 4

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Peak Serum AST and ALT Levels in Recipients Post-Transplantation
Tidsramme: From liver transplantation surgery up to post-operative Week 2
The maximum serum concentration values of AST and ALT recorded in the transplant recipient during their post-operative hospitalization.
From liver transplantation surgery up to post-operative Week 2
Time to Serum TBil Normalization in Recipients Post-Transplantation
Tidsramme: From liver transplantation surgery up to post-operative Week 2
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).
From liver transplantation surgery up to post-operative Week 2
Time to INR Normalization in Recipients Post-Transplantation
Tidsramme: From liver transplantation surgery up to post-operative Week 2
The number of days from the transplantation surgery until the recipient's INR returns to the normal reference range (0.8 to 1.5).
From liver transplantation surgery up to post-operative Week 2
Liver Graft Volume in Recipients After Transplantation
Tidsramme: From liver transplantation surgery up to post-operative Week 4
Absolute volume of the transplanted liver graft measured in mL via abdominal contrast-enhanced CT scans.
From liver transplantation surgery up to post-operative Week 4

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

West China Hospital

Samarbejdspartnere

Beijing Friendship Hospital
The Second Affiliated Hospital of Chongqing Medical University
First Affiliated Hospital of Chongqing Medical University
Anhui Provincial Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. september 2026

Primær færdiggørelse (Anslået)

31. august 2028

Studieafslutning (Anslået)

31. august 2028

Datoer for studieregistrering

Først indsendt

16. juli 2026

Først indsendt, der opfyldte QC-kriterier

16. juli 2026

Først opslået (Faktiske)

21. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

21. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2026-1206

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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

IPD-delingstidsramme

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

IPD-delingsadgangskriterier

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

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL

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