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Body-weight Reduction Effect on Portal Hypertension in Compensated Cirrhosis

Plain-language guide to NCT07797101: not phased interventional trial of Mazdutide, fatty liver & elevated liver enzymes, 50 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT07797101
Phase
not phased
Status
not yet recruiting
Start
2026-09-01
Completion (planned or actual)
2029-05-31
Participants
50 (estimated)
Design
na, open label (everyone knows who gets what), treatment
Conditions studied
Cirrhosis; Portal Hypertension; Fatty Liver Disease; GLP-1
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

The trial (not phased) is built around Mazdutide for fatty liver & elevated liver enzymes.

It had 1 arm (groups): one (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 50 planned participants were the target.

It was open to people of any sex aged from 18 years up to 75 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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).

The full record lists 8 inclusion and 17 exclusion criteria; among the exclusions: progressive jaundice during the screening period; 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.

How the Study Was Run

The set-up was single-group and open-label.

Everyone knew when Mazdutide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2026-09-01 with completion listed for 2029-05-31.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): 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)).

It also tracked 4 secondary outcomes, for example Proportion of Participants Achieving HVPG Response, Incidence of Hepatic Decompensation Events, Treatment Discontinuation Due to Adverse Events and Change in Liver and Spleen Stiffness.

What This Means in Plain Language

Put simply, this is a not phased trial of Mazdutide in 50 people with fatty liver & elevated liver enzymes.

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Mazdutide compound page, Fatty liver & elevated liver enzymes research.

Our Notes on the Compound

Mazdutide: A dual GLP-1 and glucagon receptor agonist with approvals announced in China for weight management and type 2 diabetes.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.