Can a Weight-Loss drug ease pressure in cirrhosis?

NCT ID NCT07797101

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 01, 2026 · Last updated Sep 02, 2026 · Updated 1 time

Summary

This trial tests whether mazdutide, a weekly injection that targets GLP-1 and glucagon receptors, can safely reduce portal pressure in overweight adults with compensated cirrhosis and clinically significant portal hypertension. Participants receive 16 weeks of mazdutide, with the dose gradually increased from 2 mg to 6 mg. Researchers measure portal pressure at the start and end of treatment, and track side effects, liver stiffness, body composition, and metabolic changes. The goal is to see if this drug offers a new way to manage a condition that currently has few medication options.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Mazdutide injection, a dual GLP-1/glucagon receptor agonist given as a weekly subcutaneous injection
What this could lead to
If it works, mazdutide could become a drug treatment to lower portal pressure and reduce the risk of complications in overweight people with cirrhosis.
What could go wrong
This is a small, early exploratory trial with no control group, so results may not be conclusive. The drug can cause gastrointestinal side effects, and its safety in cirrhosis with portal hypertension is unknown.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

May 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Cirrhosis are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

More trials for these conditions

Other studies related to the condition(s) this trial covers.