Efficacy, Safety, and Tolerability of CS0159 Combined With Semaglutide in MAFLD Patients With Obesity and T2DM

What Was Tested

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

This is an exploratory study evaluating CS0159 in combination with Semaglutide in metabolic dysfunction-associated fatty liver disease (MAFLD) patients with obesity and type 2 diabetes (T2DM).

It had two arms (groups): one (active comparator) and CS0159 Placebo (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

Approximately 30 patients were randomly assigned to two groups in a 1:1 ratio for treatment for 12 weeks.

Who Took Part

The registry lists 30 planned participants were the target.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: 1\. Age≥18 and ≤65 years, male or female. 3\. Diagnosis of T2DM. 6\. BMI: 30-45 kg/m2. 7\. Subjects control blood glucose only by lifestyle intervention for at least 3 months before the screening period. 9\. Can understand the research content, follow the research protocol, and voluntarily sign the ICF.

The full record lists 9 inclusion and 24 exclusion criteria; among the exclusions: 2\. use of glucose-lowering medication in the 3 months prior to randomization; 5\. subjects with t1dm, monogenic diabetes, diabetes caused by pancreatic damage, or other secondary diabetes; 6\. subjects with a history of severe pruritus.

How the Study Was Run

Design: randomized, parallel-group and triple-blind.

Random assignment meant chance, not the researchers, decided who got Semaglutide and who got the comparison, which limits bias.

Groups ran in parallel: each of the fatty liver & elevated liver enzymes participants stayed in one arm throughout.

Blinding on both sides kept the fatty liver & elevated liver enzymes participants and researchers unaware of who received Semaglutide.

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2026-06-01 with completion listed for 2026-11-30.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Percentage change in body weight relative to baseline (time frame: Baseline to 12 weeks). Changes in energy expenditure (time frame: Baseline to 12 weeks).

It also tracked 15 secondary outcomes, for example Change in patient's weight relative to the baseline, Number of participants with treatment-related adverse events as assessed by CTCAE v5.0, Change in patient's glucose oxidation, Change in patient's lipid oxidation, Percentage change in HbA1c relative to baseline and Changes relative to baseline in BMI.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Semaglutide in 30 people with fatty liver & elevated liver enzymes.

Its size is small, so on its own it can only give an early look.

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, Fatty liver & elevated liver enzymes research.