Clin2
NCT05945537Likely a fitRecruiting

Testing INI-822 in healthy people and those with MASH

Metabolic Dysfunction-Associated Steatohepatitis

Part of Digestive system clinical trials.

This study tests a new oral medication (INI-822) to see if it’s safe and how the body handles it in healthy volunteers and in people with MASH. MASH is a type of fatty liver disease with inflammation and possible scarring. If you have MASH, the study also checks if the drug can improve markers of liver health. You will need to come to the study site for visits and follow strict guidelines about birth control, alcohol, and other medicines.

Summary written for real people, not researchers, by Clin2.

Phase
Phase 1
Enrollment
168 people
Ages
18 years to 70 years
Study type
Interventional

Who can take part

  • You must be in good general health (or have MASH with specific test results).
  • You need a recent FibroScan showing fat in your liver (at least 280 dB/m) and not too much scarring.
  • Your liver enzyme level (ALT) must be above normal at least once in the past 6 months for MASH parts.
  • You cannot have other liver diseases (like hepatitis B, C, or alcoholic liver disease).
  • You must avoid alcohol during the study and limit it before visits.
  • You cannot take certain medications that interact with the study drug (e.g., warfarin, some statins, antibiotics).

View the official record on ClinicalTrials.gov

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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