Phase IIb Study to Evaluate the Efficacy and Safety of GFT505 Versus Placebo in Patients With Non-Alcoholic Steatohepatitis (NASH)

Summary

Abdominal obesity and type-2 Diabetes are associated with chronic liver disorders resulting from the accumulation of fat in the liver (steatosis), which may progress towards hepatitis and possibly lead to cirrhosis and liver cancer. NAFLD (Non Alcoholic Fatty Liver Disease) is considered as the most common form of chronic liver disease in adults in the United States, Australia, Asia and Europe. In the USA, the estimated prevalence of NAFLD is 20-30% of the adult population.

Non-alcoholic Steatohepatitis (NASH) is a progressing form of NAFLD, which corresponds to hepatic steatosis associated with inflammation and liver cell injury upon microscopic examination of a liver biopsy. This condition may lead to advanced fibrosis and cirrhosis and deserves serious medical management. Up to now, there is no effective drug which has clearly demonstrated therapeutic efficacy which may help lifestyle and dietary recommendations in the resolution of NASH.

In this context, GENFIT is developing a new liver targeted drug candidate, GFT505, for the treatment of NASH and the reduction of multiple cardiometabolic risk factors associated with the metabolic syndrome and type 2 Diabetes.

This phase IIb study will evaluate the efficacy and safety of GFT505 80mg and 120mg once daily for 52 weeks on the reversal of NASH without worsening of fibrosis, based on liver biopsy assessments.

Conditions

• Non-Alcoholic Steatohepatitis (NASH)

Interventions

DRUG

GFT505 80mg

DRUG

GFT505 120mg

DRUG

Placebo

Sponsors & Collaborators

• Naturalpha

  collaborator INDUSTRY

• Premier Research Group plc

  collaborator UNKNOWN

• Genfit

  lead INDUSTRY

Principal Investigators

• Rémy HANF, PhD · Development Director Genfit, France

• Pr. Vlad RATZIU, M.D. · International Coordinator - La Pitié-Salpêtrière Hospital - Paris 13, France

• Pr. Arun SANYAL, M.D. · National Coordinator -Virginia Commonwealth University - Richmond - USA

• Dr. Sven FRANCQUE, M.D. · National Coordinator - UZA - Edegem - Belgium

• Dr. Jost PH DRENTH, MD, Ph.D · National Coordinator - UMC St Radboud Nijmegen - Nijmegen - The Netherlands

• Pr. Michael Manns, M.D. · National Coordinator - Medical School of Hannover - Hannover - Germany

• Pr. Elisabetha BUGIANESI, M.D. · National Coordinator - University of Torino - S. Giovanni Battista Hospital - Torino - Italy

• Pr. Mihai VOICULESCU, M.D. · National Coordinator - Center of Internal Medicine, Fundeni Clinical Institute - Bucharest - Romania

• Pr. Manuel ROMERO-GOMEZ, M.D. · National Coordinator - Valme University hospital - Sevilla - Spain

• Pr. Quentin M. ANSTEE, M.D. · National Coordinator - Freeman Hospital - Newcastle - UK

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-09-30

Primary Completion

2015-02-28

Completion

2015-12-31

Countries

• United States
• Belgium
• France
• Germany
• Italy
• Netherlands
• Romania
• Spain
• United Kingdom

Study Locations