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NCT07797101Toborzás még nem indult

Body-weight Reduction Effect on Portal Hypertension in Compensated Cirrhosis

Efficacy and Safety of Mazdutide Injection for the Treatment of Overweight Patients With Compensated Cirrhosis and Clinically Significant Portal Hypertension

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. szept. 1.

Rövid összefoglaló (regiszter, angolul)

Obesity and metabolic abnormalities accelerate decompensation in compensated cirrhosis, driven by clinically significant portal hypertension (CSPH, HVPG≥10 mmHg). Lifestyle-induced weight loss can lower portal pressure, but pharmacological options are limited. Mazdutide, a dual GLP-1/glucagon receptor agonist, has proven weight-loss and glycaemic benefits, yet its safety and efficacy in cirrhosis with portal hypertension are unknown. This investigator-initiated, single-arm, open-label, exploratory trial evaluates whether mazdutide can safely reduce portal pressure in overweight patients with compensated cirrhosis and CSPH. The main questions it aims to answer are: Does 16-week mazdutide treatment reduce HVPG (percentage change from baseline)? What adverse events occur, and is the drug tolerated? Participants will: Receive mazdutide SC injection once weekly for 16 weeks, titrated from 2 mg to 4 mg to 6 mg (if tolerated), with dose adjustment for intolerance. Undergo HVPG at baseline and week 16 (primary endpoint). Have FibroScan® (liver/spleen stiffness, CAP) at baseline and weeks 4, 8, 12, 16. Provide blood samples for liver, renal, glucose, lipid, and coagulation tests at each visit. Undergo body composition, handgrip strength, and nutritional assessments to monitor muscle mass. Attend clinic visits every 4 weeks during treatment and one follow-up visit 4 weeks post-treatment. Key eligibility: Adults 18-75 with compensated cirrhosis (viral, MASLD, or alcohol-related), HVPG≥10 mmHg, BMI≥28 or ≥26 with comorbidities, stable weight, and stable carvedilol/propranolol if used. Exclude prior decompensation, HCC, CTP≥B8, eGFR\<60, mazdutide contraindications, active infection, uncontrolled hepatitis, portal vein thrombosis, etc. Endpoints: Primary - % change in HVPG. Secondary - HVPG response (≥10% decrease or \<10 mmHg), decompensation events, treatment discontinuation due to AEs. Exploratory - changes in stiffness, liver fat, metabolic parameters, body composition, nutrition. Safety: AEs (CTCAE v5.0), labs, vitals, with special monitoring for GI symptoms, dehydration, renal function, hepatic encephalopathy, muscle loss, pancreatitis, and gallbladder events. Sample size and analysis: 50 patients. Primary endpoint analysed by paired t-test or Wilcoxon (α=0.05, two-sided) in FAS and PPS. Secondary endpoints mainly descriptive; key secondary tested for support. Subgroup analyses planned if feasible. Study duration: 20 weeks (2-week screening, 16-week treatment, 4-week follow-up). Conducted at Second Affiliated Hospital of Chongqing Medical University, China. Ethics approved, informed consent required. This study will provide first evidence on mazdutide for portal hypertension in overweight cirrhosis.

Állapot (regiszter)
Toborzás még nem indult
Vizsgálattípus
Beavatkozással járó
Résztvevők száma
50 (tervezett)
Első benyújtás
2026. aug. 20.
Kezdés
2026. szept. 1.
Elsődleges befejezés
2029. máj. 31.
Fő szponzor
The Second Affiliated Hospital of Chongqing Medical University
NCT-szám
NCT07797101

Mit vállalsz

  • Vizsgálat típusa: Beavatkozással járó
  • Tervezett résztvevők: 50
  • 2026. szept. 1. és az elsődleges befejezés (2029. máj. 31.) között
  • Nincs megadott helyszín, ország nélkül
  • Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket

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Korábbi kezelés

  • Concurrent hepatocellular carcinoma or other malignancies (excluding cured basal cell carcinoma of the skin).
  • Prior history of clinically significant decompensation events (grade 2/3 ascites, overt hepatic encephalopathy, or gastroesophageal variceal bleeding).
  • Previous or current use of other weight-loss interventions (e.g., bariatric surgery, endoscopic bariatric procedures, other weight-loss drugs).
  • Participation in another interventional clinical trial within 3 months prior to screening, or previous treatment with mazdutide.
  • Prior portal-systemic shunt surgery (e.g., splenectomy).
  • Previous orthotopic liver transplantation.

Más betegség

  • Hepatic impairment defined as Child-Turcotte-Pugh (CTP) score ≥B8 at screening.
  • Contraindications to mazdutide: known allergy, personal or family history of medullary thyroid carcinoma, or multiple endocrine neoplasia syndrome type 2.
  • Active infection at screening.
  • For alcohol-related cirrhosis: alcohol abstinence \<6 months or ongoing alcohol consumption. For viral cirrhosis (hepatitis B/C): failure to achieve virologic suppression (HBV-DNA \<100 IU/mL for hepatitis B; for hepatitis C, HCV-RNA below the lower limit of detection after \>12 weeks of antiviral therapy).
  • Known portal vein thrombosis.
  • Psychiatric or cognitive disorders that interfere with study compliance.
  • Any other condition judged by the investigator to make the participant unsuitable for participation.

Laborértékek

  • Moderate to severe renal impairment (eGFR \<60 mL/min) or current renal replacement therapy.

Egyéb

  • Progressive jaundice during the screening period.
  • Contraindications to trial assessments, e.g., inability to undergo HVPG measurement.
  • Pregnancy or breastfeeding, or unwillingness to use investigator-approved contraception during the study and for 6 months after the study end.

Kiket keres a vizsgálat

  • Aged 18 to 75 years (inclusive), male or female.
  • Documented etiology of chronic liver disease, limited to chronic hepatitis B, chronic hepatitis C, metabolic dysfunction-associated steatotic liver disease (MASLD), or alcohol-related liver disease.
  • Cirrhosis confirmed by imaging (ultrasound, CT, or MRI), or pathology showing F3/F4 fibrosis, or liver stiffness measurement (LSM) ≥15 kPa by vibration-controlled transient elastography (VCTE).
  • Hepatic venous pressure gradient (HVPG) ≥10 mmHg.
  • Body mass index (BMI) ≥28 kg/m², or BMI ≥26 kg/m² with at least one weight-related comorbidity (e.g., hyperglycemia, hypertension, dyslipidemia, fatty liver, obstructive sleep apnea syndrome).
  • Stable body weight over the past 6 months, defined as weight fluctuation \<3 kg.
  • For patients with gastroesophageal varices requiring carvedilol or propranolol, the dose must have been stable for at least 3 months with no planned dose adjustments during the trial.
  • Voluntarily signed informed consent form.

Életkor a regiszterben: 18 év – 75 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad

A teljes feltétellista: ClinicalTrials.gov

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