A Study of CS060380 Tablets in Patients With MASH and Obesity

What Was Tested

The trial (phase 2) is built around Semaglutide.

This study is looking at a new investigational medicine called CS060380, when used together with semaglutide, in adults who have both metabolic dysfunction-associated steatohepatitis (MASH) and obesity.

MASH is a condition where too much fat builds up in the liver, leading to inflammation and damage.

Obesity is a major risk factor for this condition.

It had two arms (groups): Placebo + Semaglutide (placebo comparator) and one (experimental).

The registry classes the interventions as drug.

More on the Plan

The total study duration will not exceed 54 weeks, consisting of: screening period (up to 2 weeks), 36-week double-blind treatment period, and 16-week open-label period. 1.

The double-blind treatment period will employ a randomized, double-blind, placebo-controlled, parallel-group design. 2.

During the open-label period, all participants will receive CS060380. 3.

This study will enroll participants with MASH and obesity.

Who Took Part

Enrollment: 130 actual participants took part.

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: Age 18 to 65 years (inclusive), male or female. BMI ≥30 kg/m². Voluntary consent to participate in this clinical trial and provide written informed consent.

The full record lists 8 inclusion and 44 exclusion criteria; among the exclusions: use of glucagon-like peptide-1 receptor agonists (glp-1 ra) or compound preparations containing glp-1 ra components within 3 months before randomization; use of metformin, sglt2 inhibitors, and other hypoglycemic agents within 3 months before randomization; ALT ≥2.5×ULN at screening.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

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.

As a double-blind Semaglutide study, the assignments were hidden from both participants and investigators until the end.

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

It started in 2026-04-02 with completion listed for 2027-04-30.

It ran at 12 sites in China (12).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Percentage change in liver fat content from baseline to Week 36 (MRI-PDFF) (time frame: Baseline, Week 36).

It also tracked 2 secondary outcomes, for example Percentage change in body weight measured by weight scale from baseline to Week 36 and Percentage change in liver fat content (MRI-PDFF) from baseline to week 24.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Semaglutide in 130 people.

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

More context: the Semaglutide compound page, all human trials.