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Not yet recruitingPhase NA

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

Asset

Mazdutide

Subcutaneous · GLP-1 / glucagon dual

Listed sites

0

Recruiting sites

-

Estimated enrollment

50

Study population

Fibrosis, Hepatic impairment, Hypertension, MASH / NAFLD / liver fibrosis

Eligibility highlights

•BMI ≥28

Primary endpoint

•Hepatic Venous Pressure Gradient (HVPG)

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07797101
Org study ID2026-IIT-SL-233

Timeline

Milestones

Study first posted2026-09-01actual
Study start2026-09-01estimated
Last update posted2026-09-01actual
Primary completion2029-05-31estimated
Study completion2029-05-31estimated

Assets

Investigational agents

Mazdutide

Who this study enrolls

FibrosisHepatic impairmentHypertensionMASH / NAFLD / liver fibrosis

Who can enroll

Minimum age18 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•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.

Exclusion criteria

•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).
•Progressive jaundice during the screening period.
•Hepatic impairment defined as Child-Turcotte-Pugh (CTP) score ≥B8 at screening.
•Moderate to severe renal impairment (eGFR <60 mL/min) or current renal replacement therapy.
•Contraindications to mazdutide: known allergy, personal or family history of medullary thyroid carcinoma, or multiple endocrine neoplasia syndrome type 2.
•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.
•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).
•Prior portal-systemic shunt surgery (e.g., splenectomy).
•Previous orthotopic liver transplantation.
•Known portal vein thrombosis.
•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.
•Psychiatric or cognitive disorders that interfere with study compliance.
•Any other condition judged by the investigator to make the participant unsuitable for participation.

Endpoints (15)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

MASH / liver
5
Other (unclassified)
5
Weight & body composition
1
Glycemic / diabetes
1
Renal / kidney
1
Cardiometabolic biomarkers
1
Safety / tolerability / PK
1

Weight & body composition

1 endpoint
Other/protocol endpoint

Body Composition Indices (BMI, Waist-to-Hip Ratio, Waist-to-Height Ratio)

Time frame:Baseline to weeks 4, 8, 12, and 16 (Days 28, 56, 84, 112; ±3 days)

ratio, improvement

Glycemic / diabetes

1 endpoint
Other/protocol endpoint

Fasting Glucose and Lipid Profile

Time frame:Baseline to weeks 4, 8, 12, and 16 (Days 28, 56, 84, 112; ±3 days)

descriptive

MASH / liver

5 endpoints
Primary/protocol endpoint

Percentage Change in Hepatic Venous Pressure Gradient (HVPG) from Baseline

Time frame:Baseline (screening, Day -14 to -1) to Week 16 (End of Treatment, Day 112 ± 3 days)

percent change from baseline, improvement

Secondary/protocol endpoint

Incidence of Hepatic Decompensation Events

Time frame:Baseline up to Week 16 (End of Treatment)

event count, event

Other/protocol endpoint

Liver stiffness measured by VCTE

Time frame:Baseline to weeks 4, 8, 12, and 16 (Days 28, 56, 84, 112; ±3 days)

descriptive

Other/protocol endpoint

Liver Fat Content measured by Controlled Attenuation Parameter (CAP)

Time frame:Baseline to weeks 4, 8, 12, and 16 (Days 28, 56, 84, 112; ±3 days)

descriptive

Other/protocol endpoint

Liver Function Tests (ALT, AST, Bilirubin, Albumin)

Time frame:Baseline to weeks 4, 8, 12, and 16 (Days 28, 56, 84, 112; ±3 days)

descriptive

Renal / kidney

1 endpoint
Other/protocol endpoint

Renal Function (eGFR)

Time frame:Baseline to weeks 4, 8, 12, and 16 (Days 28, 56, 84, 112; ±3 days)

descriptive

Cardiometabolic biomarkers

1 endpoint
Other/protocol endpoint

Uric Acid

Time frame:Baseline to weeks 4, 8, 12, and 16 (Days 28, 56, 84, 112; ±3 days)

descriptive

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

Treatment Discontinuation Due to Adverse Events

Time frame:Day 1 (First dose) to Week 16 (End of Treatment)

descriptive

Other (unclassified)

5 endpoints
Secondary/protocol endpoint/low confidence

Proportion of Participants Achieving HVPG Response

Time frame:Baseline to Week 16 (End of Treatment, Day 112 ± 3 days)

threshold achievement, improvement

Secondary/protocol endpoint/low confidence

Change in Liver and Spleen Stiffness

Time frame:Baseline to Week 16 (End of Treatment, Day 112 ± 3 days)

change from baseline, improvement

Other/protocol endpoint/low confidence

Spleen Stiffness measured by VCTE

Time frame:Baseline to weeks 4, 8, 12, and 16 (Days 28, 56, 84, 112; ±3 days)

descriptive

Other/protocol endpoint/low confidence

Coagulation Function (PT, INR, APTT)

Time frame:Baseline to weeks 4, 8, 12, and 16 (Days 28, 56, 84, 112; ±3 days)

descriptive

Other/protocol endpoint/low confidence

Urine Protein

Time frame:Baseline to weeks 4, 8, 12, and 16 (Days 28, 56, 84, 112; ±3 days)

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateNovember 5, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the November 5, 2026 snapshot.