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NATIiV3 Study for NASH and Stage 3 Liver Fibrosis

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A randomised, double-blind, placebo-controlled, multicentre, Phase 3 study evaluating long-term efficacy and safety of lanifibranor in adult patients with non-cirrhotic non-alcoholic steatohepatitis (NASH) and fibrosis 2 (F2)/fibrosis 3 (F3) stage of liver fibrosis

  • Sex: Any
  • Age: Adult (18 - 64), Older Adult (65+)
  • Accepting Healthy People: No
  • Type: Interventional / Therapeutic
  • Trial Phase: Phase III
  • Conditions Being Studied: Liver, Nonalcoholic Fatty Liver Disease

Study Purpose

The purpose of this research study is to evaluate if the study investigational medication improves your liver tissue scars (fibrosis) and resolves NASH. The study will also evaluate on the long term if the study medication can delay the complications that can ultimately damage the liver function (NASH disease progression).

Who Can Participate

Participants 18 years and older with a diagnosis of NASH may be eligible for this study.

Principal Investigator
Pierre Gholam MD
Department/Division
Medicine (Gastroenterology)

Locations

UH Minoff Health Center at Chagrin Highlands
3909 Orange Place
Orange Village OH, 44122

UH Cleveland Medical Center
11100 Euclid Avenue
Cleveland OH, 44106

UH Westlake Health Center
960 Clague Road
Westlake OH, 44145

  • UH IRB: SITE00001580
  • StudyID: 2021-0723
  • ClinicalTrials.gov: NCT04849728
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