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337HNAS200115 (NATiV3)

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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 at Birth: 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

NASH is a liver disease associated with inflammation and liver cell injury visible under a microscope with a liver biopsy. This condition may lead to advanced scarring of the liver called fibrosis and cirrhosis and deserves serious medical management. The study has 2 main goals: 1. Evaluate if the study medication improves your liver tissue scars (fibrosis) and resolves NASH. This is assessed by a biopsy of your liver that will be done after 72 weeks of treatment. 2. Evaluate on the long term if the study medication can delay the complications that can ultimately damage the liver function (NASH disease progression). You will continue the same treatment until the study collects enough information, without exceeding 7 years, and a final liver biopsy will be done.

Who Can Participate

Age: 18 and above

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

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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