Drug ADI-PEG 20 for NASH in people with mild cirrhosis
Treatments studied
Part of Digestive system clinical trials.
This trial tests ADI-PEG 20 against a placebo (inactive pill) to see if it improves liver disease in people with NASH and compensated cirrhosis. It may help by targeting liver fat and inflammation seen on scans and biopsy.
Summary written for real people, not researchers, by Clin2.
Who can take part
- You’re age 18–80 and assigned male, or for non-pregnant/non-breastfeeding females with a negative pregnancy test.
- Your NASH diagnosis must be confirmed by a recent or recent-within-6-months liver biopsy, showing specific levels of fat, swelling, and inflammation.
- Your liver scarring stage must be F1 to F4, and people with the mildest stage (F1) make up a limited portion of the study.
- Your MRI scan must show at least 5% liver fat, and your FibroScan reading must be between 7.0 and 20.0 kPa.
- You must be able to safely have MRI scans (no certain metal devices/implants) and agree to use effective birth control during treatment and for 90 days after.
- You must avoid alcohol above the trial limit and have certain blood test results (kidney function, liver enzymes, clotting) within allowed ranges.
Quick eligibility check
Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.
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