| Iqirvo (elafibranor) / Ipsen |
NCT01694849 / 2012-000295-42: Phase IIb Study to Evaluate the Efficacy and Safety of GFT505 Versus Placebo in Patients With Non-Alcoholic Steatohepatitis (NASH) |
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| Completed | 2b | 275 | Europe, US | GFT505 80mg, GFT505 120mg, Placebo | Genfit, Naturalpha, Premier Research Group plc | Non-Alcoholic Steatohepatitis (NASH) | 02/15 | 12/15 | | |
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| Completed | 2 | 96 | Europe, RoW | GFT505 80mg, Placebo | Genfit | Atherogenic Dyslipidaemia, Abdominal Obesity | 09/09 | 11/09 | | |
| Completed | 2 | 47 | Europe | GFT505 80mg, Placebo | Genfit | Impaired Glucose Tolerance, Abdominal Obesity | 12/09 | 01/10 | | |
| Completed | 2 | 97 | Europe, RoW | GFT505 80mg, Placebo | Genfit | Type II Diabetes Mellitus | 06/11 | 06/11 | | |
NCT01271777: Pilot Study With GFT505 (80mg) in Patients With Insulin Resistance and Abdominal Obesity |
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| Completed | 2 | 22 | Europe | GFT505 80mg, Placebo | Genfit | Insulin Resistance, Abdominal Obesity | 11/11 | 11/11 | | |
2010-023219-32: A Pilot study to evaluate the Efficacy of GFT505 (80mg) orally administered once daily for 8 weeks on insulin sensitivity and hepatic glucose production using a glucose clamp technique and Safety in patients with insulin resistance and abdominal obesity.A Multicentre, Randomised, Single Blind, Placebo-Controlled, cross over study. |
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| Not yet recruiting | 2 | 20 | Europe | GFT505 20mg lactose - magnesium stearate, GFT505, Capsule, hard | GENFIT | Patients with insulin resistance and abdominal obesity | | | | |
NCT03124108 / 2016-003817-80: Study to Evaluate the Efficacy and Safety of Elafibranor in Patients With Primary Biliary Cholangitis (PBC) and Inadequate Response to Ursodeoxycholic Acid |
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| Completed | 2 | 45 | Europe, US | Elafibranor 80 mg, GFT505, Elafibranor 120 mg, Placebo | Genfit | Primary Biliary Cholangitis (PBC) | 10/18 | 10/18 | | |
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NCT03953456: Study to Evaluate the Effect of Elafibranor on Hepatic Lipid Composition in Subjects With Nonalcoholic Fatty Liver (NAFL) |
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| Terminated | 2 | 17 | Europe | elafibranor 120mg, GFT505, Placebo | Genfit | Non-Alcoholic Fatty Liver | 03/20 | 07/20 | | |
NCT03883607 / 2019-003400-12: Elafibranor, PK and Safety in Children and Adolescents 8 to 17 Years of Age With Non Alcoholic Steatohepatitis (NASH) |
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| Terminated | 2 | 10 | US | Elafibranor 80mg, GFT505, Elafibranor 120mg | Genfit | Non Alcoholic Steatohepatitis | 06/20 | 06/20 | | |
2019-000645-12: Clinical study to assess the effect of a 6-week Elafibranor (120mg) treatment administered once daily on liver fat composition in subjects with Nonalcoholic Fatty Liver (NAFL). |
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| Not yet recruiting | 2 | 16 | Europe | elafibranor, GFT505, Coated tablet | GENFIT SA, GENFIT | Subjects with Nonalcoholic Fatty Liver (NAFL), Non-Alcoholic Fatty Liver (NAFL)., Diseases [C] - Nutritional and Metabolic Diseases [C18] | | | | |
2022-002695-37: A study on safety and efficacy of Elafibranor in Adult Participants with Primary Sclerosing Cholangitis (PSC) Estudio sobre la seguridad y la eficacia del elafibranor en participantes adultos con colangitis esclerosante primaria (CEP) |
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| Ongoing | 2 | 60 | Europe | IPN60190; GFT505, Tablet | Ipsen Bioscience, Inc., Ipsen Bioscience, Inc. | Adults patients with Primary Sclerosing Cholangitis (PSC) Pacientes adultos con colangitis esclerosante primaria (CEP), Primary Sclerosing Cholangitis (PSC) is a progressive liver disease characterised by inflammation and fibrosis of the bile ducts with risk of liver failure. La colangitis esclerosante primaria (CEP) es una enfermedad hepática progresiva caracterizada por inflamación y fibrosis de los conductos biliares, con riesgo de insuficiencia hepática., Body processes [G] - Metabolic Phenomena [G03] | | | | |
| Recruiting | 2 | 60 | Europe, Canada, US | Elafibranor 80 mg, GFT505, Elafibranor 120 mg, Placebo Matched to Elafibranor 80 mg, Placebo Matched to Elafibranor 120 mg | Ipsen, Ipsen Bioscience, Inc. | Primary Sclerosing Cholangitis | 12/24 | 12/24 | | |
