Efficacy and Safety of Mazdutide in Patients With Type 2 Diabetes Mellitus and Moderate to Severe Nonalcoholic Fatty Liver Disease Previously Treated With Semaglutide

What Was Tested

This registered not phased trial tested Semaglutide and Mazdutide for fatty liver & elevated liver enzymes.

It had two arms (groups): Mazdutide Treatment Group (experimental) and Semaglutide Maintenance Group (active comparator).

The registry classes the interventions as drug.

Who Took Part

72 planned participants were the target.

It was open to people of any sex aged from 18 years up to 60 years.

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

Examples of who could join: Aged between 18 and 60 years (inclusive) at the time of informed consent signing. Diagnosed with type 2 diabetes mellitus. Body mass index (BMI) ≥24 kg/m². Glycemic and weight management regimens without adjustments within 3 months prior to screening. Voluntarily signed written informed consent and agreed to comply with the study protocol.

The full record lists 8 inclusion and 11 exclusion criteria; among the exclusions: history of alcoholic fatty liver, drug-induced fatty liver, viral hepatitis, autoimmune diseases, or acute gallbladder diseases; use of weight-loss drugs or alternative weight-loss therapies within 3 months prior to screening; addition to sulfonylureas, glinides, dorzagliatin, or various insulin preparations within 3 months prior to screening.

How the Study Was Run

Design: randomized, parallel-group and open-label.

Because people in this Semaglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Semaglutide group and the comparison group ran side by side rather than switching.

Being open-label, the Semaglutide study did not mask who received what.

It started in 2026-09-15 with completion listed for 2027-12-31.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Absolute change in liver fat content measured by MRI-PDFF (time frame: Baseline, Week 16, Week 32). Absolute change in liver fat content measured by liver transient elastography (time frame: Baseline, Week 16, Week 32).

It also tracked 14 secondary outcomes, for example Absolute change in fasting plasma glucose (FPG), Absolute change in glycated hemoglobin (HbA1c), Changes in derived indices from oral glucose tolerance test (OGTT) from baseline to study endpoint, Absolute change in liver stiffness measurement (LSM), Absolute change in body weight and Absolute change in total cholesterol (TC).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Semaglutide and Mazdutide in 72 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 Semaglutide compound page and the Mazdutide compound page, Fatty liver & elevated liver enzymes research.