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Obesity / CS060380 / Metabolic Dysfunction Associated Steatohepatitis (MASH) · Phase 2 Trial
ClinicalTrials.gov · August 10, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a Phase 2 clinical trial registration (not results) evaluating CS060380 in combination with semaglutide for adults with MASH and obesity. The trial uses a 36-week double-blind, placebo-controlled design followed by a 16-week open-label extension, with liver fat content (MRI-PDFF) as the primary endpoint. No outcome data are posted in this registry record; the study is active but not recruiting.
Phase 2, Interventional, Randomized, Parallel, Quadruple masking, Treatment purpose. Metabolic Dysfunction-associated Steatohepatitis (MASH), Obesity; age from 18 Years; to 65 Years. Intervention: CS060380 1.0 mg + Semaglutide. Compared with: Placebo + Semaglutide — Placebo Comparator. n = 130. 12 sites: China.
This is a Phase 2 clinical trial registration (not results) evaluating CS060380 in combination with semaglutide for adults with MASH and obesity. The trial uses a 36-week double-blind, placebo-controlled design followed by a 16-week open-label extension, with liver fat content (MRI-PDFF) as the primary endpoint. No outcome data are posted in this registry record; the study is active but not recruiting.
No results, effect sizes, safety data, or comparator arms are reported in this registry entry.
No clinical impact can be assessed from this registry record, as no results are posted. Clinicians should monitor for publication of findings when the trial concludes to evaluate the efficacy and safety of CS060380 combined with semaglutide in this population.
Phase 2 interventional trial in recruitment with no posted results; represents early-stage efficacy and safety testing of an investigational drug combination.
As stated by the source record.
Quoted from the source exactly as published.
No clinical impact can be assessed from this registry record, as no results are posted. Clinicians should monitor for publication of findings when the trial concludes to evaluate the efficacy and safety of CS060380 combined with semaglutide in this population.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07466017). This is a study registration, not published results. Lead sponsor: Cascade Pharmaceuticals, Inc. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 130 participants (ACTUAL). Conditions: Metabolic Dysfunction-associated Steatohepatitis (MASH), Obesity. Interventions: DRUG: semaglutide; DRUG: CS060380; DRUG: Placebo. Primary outcome measures: Percentage change in liver fat content from baseline to Week 36 (MRI-PDFF) , Baseline, Week 36. Brief 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.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.