A Study of CS060380 Tablets in Patients With MASH and Obesity

NCT07466017 · Recruiting

Last updated 2026-05-28

This clinical trial is testing the effects of CS060380 tablets on liver fat and obesity in adults with metabolic dysfunction-associated steatohepatitis (MASH) and obesity.

Status Recruiting Currently enrolling participants.

Phase Phase 2 Tests whether it works and watches safety in a moderate group.

Type Interventional (clinical trial)

Design Randomized, quadruple-blind treatment study

Participants 120 people Planned (estimated).

Who can join Ages 18–65 · all sexes

Timeline Started 2026-04 · est. completion 2027-07

Where 12 sites · China

What this study is testing ClinicalTrials.gov NCT07466017 ↗

Description as written by the study sponsor.

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. This is a Phase II clinical trial, which means we are testing the medicine to see if it works and is safe. The study will last up to 54 weeks, which is a little over a year. It includes: * A screening period of up to 2 weeks to check if you are eligible to take part. * A 36-week double-blind treatment period, where you will be randomly assigned (like flipping a coin) to receive either the study drug CS060380 or a placebo (an inactive pill that looks like the study drug). Both groups will also receive semaglutide, which is an approved medicine for weight management. Neither you nor your doctor will know which treatment you are receiving. * A 16-week open-label period, where all participants will receive CS060380. The main goal of this study is to see how the study drug affects the amount of fat in the liver, measured by a special MRI scan, and body weight. We will also monitor your overall health and safety throughout the study by checking your vital signs, doing blood and urine tests, and asking about any side effects you might experience. About 120 participants will take part in this study at almost 15 different hospitals across China, with Ruijin Hospital in Shanghai as the main study site.

Treatments tested

semaglutide Drug

Semaglutide 1.7 mg as the background therapy for all participants
CS060380 Drug

CS060380 1.0 mg tablets for the treatment of metabolic dysfunction-associated steatohepatitis complicated with obesity
Placebo Drug

Placebo tablets matching CS060380 of double-blind control for 36 weeks

Main thing measured	Percentage change in liver fat content from baseline to Week 36 (MRI-PDFF)
Sponsor	Cascade Pharmaceuticals, Inc
Conditions studied	Metabolic Dysfunction-associated Steatohepatitis (MASH), Obesity
GLP-1 drugs	—

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT07466017 ↗