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A Randomized, Controlled Trial of the Pan-PPAR Agonist Lanifibranor in NASH

by Balabanska, Rozalina , Abitbol, Jean-Louis , Rouzier, Régine , Harrison, Stephen A , Francque, Sven M , Romero-Gómez, Manuel , Guillaume, Maeva , Junien, Jean-Louis , Schattenberg, Jörn M , Mateva, Lyudmila , Bedossa, Pierre , Anstee, Quentin M , Ratziu, Vlad , Loomba, Rohit , Baudin, Martine , Hodge, Alexander , Moreno, Christophe , Stefanova-Petrova, Diana , Abdelmalek, Manal F , Bugianesi, Elisabetta , Lanthier, Nicolas , Vonghia, Luisa , Richard, Marie-Paule , Sanyal, Arun J , Huot-Marchand, Philippe , Broqua, Pierre , Alkhouri, Naim

in Adverse events / Agonists / Apolipoproteins / Balloon treatment / Benzothiazoles - administration & dosage / Benzothiazoles - adverse effects / Benzothiazoles - therapeutic use / Biopsy / Body Mass Index / Cholesterol / Clinical trials / Confidence intervals / Diabetes / Diabetes mellitus (non-insulin dependent) / Diabetes Mellitus, Type 2 - complications / Diarrhea / Diet / Dose-Response Relationship, Drug / Double-Blind Method / Edema / Female / Fibrosis / Gastroenterology / Gastroenterology General / Gene expression / Humans / Inflammation / Insulin resistance / Life Sciences / Liver Cirrhosis - drug therapy / Liver Cirrhosis - etiology / Liver Disease / Liver diseases / Male / Metabolism / Middle Aged / Nausea / Non-alcoholic Fatty Liver Disease - drug therapy / Non-alcoholic Fatty Liver Disease - etiology / Nutrition / Patients / Peroxisome proliferator-activated receptors / Peroxisome Proliferator-Activated Receptors - agonists / Placebos / Population / Severity of Illness Index / Statistical analysis / Steatosis / Sulfonamides - administration & dosage / Sulfonamides - adverse effects / Sulfonamides - therapeutic use

2021

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A Randomized, Controlled Trial of the Pan-PPAR Agonist Lanifibranor in NASH

2021

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A Randomized, Controlled Trial of the Pan-PPAR Agonist Lanifibranor in NASH

2021

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Journal Article

A Randomized, Controlled Trial of the Pan-PPAR Agonist Lanifibranor in NASH

Balabanska, Rozalina,

Abitbol, Jean-Louis,

Rouzier, Régine,

Harrison, Stephen A,

Francque, Sven M,

Romero-Gómez, Manuel,

Guillaume, Maeva,

Junien, Jean-Louis,

Schattenberg, Jörn M,

Mateva, Lyudmila,

Bedossa, Pierre,

Anstee, Quentin M,

Ratziu, Vlad,

Loomba, Rohit,

Baudin, Martine,

Hodge, Alexander,

Moreno, Christophe,

Stefanova-Petrova, Diana,

Abdelmalek, Manal F,

Bugianesi, Elisabetta,

Lanthier, Nicolas,

Vonghia, Luisa,

Richard, Marie-Paule,

Sanyal, Arun J,

Huot-Marchand, Philippe,

Broqua, Pierre,

Alkhouri, Naim

2021

Overview

Lanifibranor is a pan–peroxisome proliferator–activated receptor agonist that modulates metabolic and inflammatory pathways. In this 24-week, phase 2b, placebo-controlled trial involving patients with NASH, 1200 mg of lanifibranor, but not 800 mg, significantly improved histologic features of NASH. Weight gain, anemia, peripheral edema, diarrhea, and nausea occurred more frequently with lanifibranor than with placebo.

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Publisher

Massachusetts Medical Society

Subject

/ Benzothiazoles - administration & dosage

/ Benzothiazoles - adverse effects

/ Benzothiazoles - therapeutic use