NCT07797101Not yet recruiting
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
Source: ClinicalTrials.gov · Last updated 1 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 20 Aug 2026
- Start date
- 1 Sept 2026
- Primary completion date
- 31 May 2029
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical University
- NCT number
- NCT07797101
What you commit to
- Study type: Interventional
- Planned participants: 50
- From 1 Sept 2026 to the primary completion date, 31 May 2029
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Lab values
- Moderate to severe renal impairment (eGFR \<60 mL/min) or current renal replacement therapy.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.