A Study of CS060380 Tablets in Patients With MASH and Obesity

Sponsor
Cascade Pharmaceuticals, Inc
Study ID
NCT07466017
Phase
PHASE2
Status
Recruiting
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Conditions

  • Metabolic Dysfunction-associated Steatohepatitis (MASH)
  • Obesity

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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.

Key Dates

Start date
Apr 2, 2026
Status verified
Feb 2026
Primary completion
Apr 30, 2027
Completion
Jul 30, 2027

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo + Semaglutide
    Participants receive CS060380 placebo tablets orally once daily in combination with semaglutide 1.7 mg subcutaneously once weekly for 36 weeks during the double-blind treatment period.
  • Experimental: CS060380 1.0 mg + Semaglutide
    Participants receive CS060380 1.0 mg tablets orally once daily in combination with semaglutide 1.7 mg subcutaneously once weekly for 36 weeks during the double-blind treatment period.

Primary Outcome Measure

Percentage change in liver fat content from baseline to Week 36 (MRI-PDFF) [ Time Frame: Baseline, Week 36 ]

Central Contacts

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