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A Phase 3 Study Evaluating Efficacy and Safety of Lanifibranor Followed by an Active Treatment Extension in Adult Patients With (NASH) and Fibrosis Stages F2 and F3 ( NATiV3 )

Testing lanifibranor's safety and effectiveness for liver fibrosis in adults.

Recruiting
18 years and older
All
Phase 3

Lanifibranor is a drug being tested for treating adults with NASH (Non-Alcoholic Steatohepatitis), a liver disease, and fibrosis stages F2 and F3. This study has two parts: Part A compares lanifibranor with a placebo (a harmless pill that doesn’t contain active medicine), and Part B continues the treatment to ensure its safety.

In Part A, the goal is to see if lanifibranor is safe and can heal the liver by reducing liver damage and improving fibrosis, which is a thickening or scarring of liver tissue. Part B will focus on making sure the drug is safe over a longer period. There are specific criteria for joining this study, like being diagnosed with NASH and having certain levels of liver damage.

To join the study, participants must be adults (18 and older) and meet specific health requirements. They should not have other liver diseases or be receiving certain other treatments. It is important participants have stable weight and follow specific guidelines during the study.

  • The study is divided into two parts, involving treatment and safety assessment.
  • Participants must meet specific health criteria to be eligible.
  • There is no mention of compensation for participation in the study.
Study details
    NASH - Nonalcoholic Steatohepatitis

NCT04849728

Inventiva Pharma

13 December 2024

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