NCT07466017

A Study of CS060380 Tablets in Patients With MASH and Obesity

A Randomized, Double-blind, Placebo-controlled, Parallel-group Phase II Study to Evaluate the Efficacy and Safety of CS060380 Tablets in Patients With Metabolic Dysfunction-associated Steatohepatitis (MASH) and Obesity.

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Cascade Pharmaceuticals, Inc · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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. A total of 120 participants are planned for enrollment. 4. Eligible participants will be randomized in a 1:1 ratio to Control Group A (60 participants) and Experimental Group B (60 participants). 5. Both groups will receive semaglutide 1.7 mg as background therapy. Control Group A will receive placebo, while Experimental Group B will receive CS060380 1.0 mg. 6. Interim analyses will be conducted when approximately 80% of participants complete Week 16 and Week 24 visits. 7. The sponsor will decide whether to continue the open-label study based on safety and efficacy data.

Conditions

• Metabolic Dysfunction-associated Steatohepatitis (MASH)
• Obesity

Interventions

Type	Name	Description
DRUG	semaglutide	Semaglutide 1.7 mg as the background therapy for all participants
DRUG	CS060380	CS060380 1.0 mg tablets for the treatment of metabolic dysfunction-associated steatohepatitis complicated with obesity
DRUG	Placebo	Placebo tablets matching CS060380 of double-blind control for 36 weeks

Timeline

• Start date: 2026-04-02
• Primary completion: 2027-04-30
• Completion: 2027-07-30
• First posted: 2026-03-12
• Last updated: 2026-04-13

Locations

14 sites across 1 country: China