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Um estudo para avaliar a segurança e a eficácia do elafibranor em participantes adultos com colangite esclerosante primária. (ELMWOOD)

20 de outubro de 2026 atualizado por: Ipsen

Um estudo de fase II, multicêntrico, duplo-cego, randomizado, controlado por placebo e extensão de longo prazo aberta para avaliar a segurança e a eficácia do elafibranor em participantes adultos com colangite esclerosante primária (PSC).

This study will evaluate the effects of elafibranor (the study drug) in participants with Primary Sclerosing Cholangitis (PSC) during the double-blind period, an initial 96 week open-label extension (OLE) period, and an optional open-label extension long-term (OLE-LT) period beyond OLE Week 96. PSC is a rare disease of the liver that leads to injury and destruction of bile ducts. Damage to bile ducts leads to buildup of bile in the liver, which then causes further damage, and leads to disease progression. This study will compare elafibranor to a placebo, a dummy treatment. The main objective of the trial will be to study the safety and side effects of the study drug, including long-term safety during the open-label extension periods. The trial will also study the study drug's effects on blood tests and other tests related to PSC disease activity.

Visão geral do estudo

Status

Ativo, não recrutando

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

68

Estágio

  • Fase 2

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Alemanha
      • Berlin, Alemanha, 13353
        • Charite Campus Virchow
      • Frankfurt, Alemanha, 60590
        • Klinikum der Johann Wolfgang Goethe-Universitaet Frankfurt
      • Heidelberg, Alemanha, 69120
        • Universitaetsklinikum Heidelberg - Nationales Centrum fuer Tumorerkrankungen
      • Ulm, Alemanha, 89081
        • University Hospital Ulm
  • Canadá
      • Calgary, Canadá, T3H 0V5
        • Aspen Woods Clinic
      • Montreal, Canadá, H2X 0A9
        • Centre de Recherche du Centre Hospitalier de l'Universite de Montreal
      • Vancouver, Canadá, V6Z 2K5
        • G.I Research Institute
    • Alberta
      • Calgary, Alberta, Canadá, T2N 4Z6
        • University of Calgary
      • Edmonton, Alberta, Canadá, T6G 2X8
        • University Of Alberta Hospital-Zeidler Ledcor Centre
    • Ontario
      • Brampton, Ontario, Canadá, L6R 3J7
        • Brampton Civic Hospital (BCH) - Osler Hepatitis Centre
  • Espanha
      • Barcelona, Espanha, 08035
        • Hospital Universitario Vall d'Hebron
      • Madrid, Espanha, 28046
        • Hospital Universitario La Paz
      • Madrid, Espanha, 28007
        • Hospital General Universitario Gregorio Maranon (HGUGM)
      • Majadahonda, Espanha, 28222
        • Hospital Universitario Puerta de Hierro
      • Pontevedra, Espanha, 36071
        • Hospital De Montecelo
      • Valladolid, Espanha, 47012
        • Hospital Universitario Rio Hortega
      • Zaragoza, Espanha, 50009
        • Hospital Universitario Miguel Servet
  • Estados Unidos
    • California
      • Lancaster, California, Estados Unidos, 93534
        • Om Research LLC
      • Los Angeles, California, Estados Unidos, 90048
        • Cedars-Sinai Medical Center
      • Sacramento, California, Estados Unidos, 95817
        • University of California, Davis
      • San Francisco, California, Estados Unidos, 94109
        • Sutter Health Van Ness Campus Medical Office Building
    • Colorado
      • Colorado Springs, Colorado, Estados Unidos, 80907
        • Peak Gastroenterology Associates
      • Englewood, Colorado, Estados Unidos, 80113
        • South Denver Gastroenterology,P.C.
      • Littleton, Colorado, Estados Unidos, 80120
        • Rocky Mountain Gastroenterology (RMG)
    • Connecticut
      • New Haven, Connecticut, Estados Unidos, 06510
        • Yale University School Of Medicine - Yale Center For Clinical Investigation
    • Florida
      • Miami, Florida, Estados Unidos, 33136
        • Schiff Center for Liver Diseases - University of Miami
      • Sarasota, Florida, Estados Unidos, 34240
        • Covenant Research
    • Georgia
      • Atlanta, Georgia, Estados Unidos, 30309
        • Piedmont Hospital - Piedmont Transplant Institute
    • Louisiana
      • Marrero, Louisiana, Estados Unidos, 70072
        • Tandem Clinical Research GI
    • Maryland
      • Baltimore, Maryland, Estados Unidos, 21202
        • Mercy Medical Center
    • Massachusetts
      • Boston, Massachusetts, Estados Unidos, 02215
        • Beth Israel Deaconess Medical Center, Liver Research Center
    • Michigan
      • Ypsilanti, Michigan, Estados Unidos, 48197
        • Huron Gastroenterology Associates - Center for Digestive Care
    • Nebraska
      • Omaha, Nebraska, Estados Unidos, 68198
        • University of Nebraska Medical Center
    • New Mexico
      • Albuquerque, New Mexico, Estados Unidos, 87109-4342
        • Southwest Gastroenterology Associates, PC (SWGA)
    • New York
      • New York, New York, Estados Unidos, 06510
        • New York University Langone Health
    • Ohio
      • Cincinnati, Ohio, Estados Unidos, 45219
        • Gastro Health Research
    • Pennsylvania
      • Hershey, Pennsylvania, Estados Unidos, 17033
        • Penn State Milton S Hershey Medical Center
      • Philadelphia, Pennsylvania, Estados Unidos, 19017
        • Thomas Jefferson University
    • South Carolina
      • Charleston, South Carolina, Estados Unidos, 29425
        • Medical University of South Carolina
    • Tennessee
      • Cordova, Tennessee, Estados Unidos, 38018
        • Gastro One
    • Texas
      • Dallas, Texas, Estados Unidos, 75235
        • University Of Texas Southwestern Medical Center At Dallas
      • San Antonio, Texas, Estados Unidos, 78215
        • American Research Corporation at The Texas Liver Institute
    • Utah
      • Murray, Utah, Estados Unidos, 84107
        • Intermountain Medical Center
    • Virginia
      • Charlottesville, Virginia, Estados Unidos, 22093
        • University of Virginia Medical Center
      • Richmond, Virginia, Estados Unidos, 23298
        • Virginia Commonwealth University
      • Richmond, Virginia, Estados Unidos, 23226
        • Bon Secours Richmond Community Hospital LLC. d/b/a Bon Secours Liver Institute of Richmond
    • Washington
      • Seattle, Washington, Estados Unidos, 98105
        • Liver Institute Northwest
  • Itália
      • Modena, Itália, 41124
        • Azienda Ospedaliero Universitaria Modena
      • Padova, Itália, 35128
        • Azienda Ospedaliera di Padova - U.O.C. di Gastroenterologia
      • Palermo, Itália, 90127
        • Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
      • Rozzano, Itália, 20089
        • Gruppo Humanitas - Humanitas Research Hospital, Istituto Clinico Humanitas
      • San Giovanni Rotondo, Itália, 71013
        • Ospedale Casa Sollievo della Sofferenza
  • Portugal
      • Guimarães, Portugal, 4800-055
        • Centro Hospitalar do Alto Ave - Hospital Senhora da Oliveira
      • Lisbon, Portugal, 1345-035
        • Centro Hospitalar Universitario Lisboa Norte
      • Lisbon, Portugal, 1349-019
        • Centro Hospitalar de Lisboa ocidental (CHLO), Hospital Egas Moniz
  • Reino Unido
      • Aberdeen, Reino Unido, AB25 2ZD
        • Aberdeen Royal Infirmary NHS Grampian Grampian Health Board
      • Birmingham, Reino Unido, B15 2TT
        • Queen Elizabeth Hospital
      • Frimley, Reino Unido, GU16 7UJ
        • Frimley Park Hospital - Frimley Health NHS Foundation Trust
      • Glasgow, Reino Unido, G4 0SF
        • Glasgow Royal Infirmary - Greater Glasgow Health Board
      • Hull, Reino Unido, HU3 2JZ
        • Hull Royal Infirmary - Hull University Teaching Hospitals NHS Trust
      • London, Reino Unido, NW3 2QG
        • The Royal Free Hospital - Royal Free London NHS Foundation Trust
      • London, Reino Unido, E1 1BB
        • Ambrose King Centre-Royal London Hospital-Barts Health NHS Trust

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 75 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria :

The following inclusion criteria apply to entry into the double-blind period and initial open-label extension (OLE) period up to OLE Week 96, unless otherwise specified.

  • Participants with a diagnosis of Primary sclerosing cholangitis (PSC) as demonstrated by the presence of the following, and in the absence of apparent causes of secondary sclerosing cholangitis: i) Historical evidence of an elevated Alkaline phosphatase (ALP) > Upper Limit Normal (ULN) since at least 6 months prior to SV1. ii) Cholangiogram (e.g. magnetic resonance cholangiopancreatography (MRCP), endoscopic retrograde cholangiopancreatography (ERCP), percutaneous transhepatic cholangiography (PTC) with features compatible with large duct PSC.
  • ALP ≥1.5x ULN during screening (with variability ≤30% based on two values).
  • Total bilirubin ≤2.0x ULN at Screening Visit 1(SV1)
  • Participants taking ursodeoxycholic acid (UDCA) at a total daily dose ≤23 mg/kg/day, with a minimum of 6 months of stable treatment prior to screening period and expected to remain on stable dose through the 12-week DBP. Minimum of 3 months off treatment prior to screening period if UDCA was recently discontinued.
  • For participants with Inflammatory bowel disease (IBD): i) Participants with Crohn's disease must be in remission based on the investigator's clinical assessment and should be on stable treatment prior to randomisation and during screening. ii) Participants with ulcerative colitis must be in remission or have low activity disease as per the judgement of the investigator and should be on stable treatment prior to randomisation and during screening. iii) Current treatment for IBD is permitted, if the participant has been well controlled for ≥3 months prior to the screening period and is anticipated to remain on a stable dose of drugs for IBD treatment, including biologics, immunosuppressants, immunomodulators, or systemic corticosteroids. iv) Participants with IBD should have a colonoscopy performed within one year prior to the screening period showing no evidence of dysplasia or cancer.
  • Medications for management of pruritus (e.g. cholestyramine, rifampin, naltrexone or sertraline) must be on a stable dose for ≥3 months prior to the screening period.
  • Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. -A female participant is eligible to participate if she is not pregnant or breastfeeding at screening, is willing not to become pregnant during the study and is willing to follow applicable protocol requirements related to this. - Male participants are eligible to participate if they agree to follow applicable protocol requirements related to contraception.
  • Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

Inclusion Criteria for Entry into Optional Open-Label Extension Long-Term (OLE-LT) Period Beyond Week 96

For entry into the optional OLE-LT period, participants:

  • Must have completed the initial OLE period up to OLE Week 96
  • Must not have permanently discontinued the study intervention during the initial OLE period
  • Must, in the opinion of the investigator, benefit from continuing to receive study intervention The eligibility criteria assessed at Screening Visit 1 (SV1) for entry into the double-blind period are not reassessed for entry into the optional OLE-LT period.

Contraception requirements applicable during the OLE-LT period:

  • Male participants: No contraception requirements apply.
  • Female participants of childbearing potential: Must continue to use a highly effective contraceptive method during study intervention and for at least one month after the last dose. If using a hormonal contraceptive, an additional barrier method or a switch to a highly effective non-hormonal method is required.

Exclusion Criteria :

  • History or presence of other concomitant chronic liver disease including: i) ImmunoglobulinG 4 (IgG4) related sclerosing cholangitis, or IgG4 ≥4x ULN at SV1. ii) Small duct PSC. iii) Documented history of secondary sclerosing cholangitis. iv) Presence of hepatitis B surface antigen (HBsAg) at screening. v) Hepatitis C virus (HCV) infection vi) Primary biliary cholangitis (PBC) or positive anti-mitochondrial antibody. vii) Alcohol-related liver disease. viii) Autoimmune hepatitis (AIH): Simplified Diagnostic Criteria of the IAIHG ≥6. ix) Presence of history of PSC-PBC or PSC-AIH overlap syndrome. x) Non-alcoholic steatohepatitis (NASH). SMD form protocol master data--23- INT / Version 1 Known history of alpha-1 antitrypsin deficiency
  • Presence of percutaneous drain or bile duct stent at screening or within three months prior to screening.
  • History of bacterial cholangitis within 60 days prior to the screening period, or participant on antibiotics for prophylaxis of recurrent cholangitis.
  • History or any current suspicion of cholangiocarcinoma or elevated value of carbohydrate antigen 19-9 (CA19-9) >129 U/mL at SV1.
  • Alpha-fetoprotein (AFP) >20 ng/mL with 4-phase liver computerised tomography (CT) or magnetic resonance imaging (MRI) suggesting presence of liver cancer.
  • Participants with cirrhosis who are also classified as Child-Pugh B or C based on the Child-Pugh score. Participants with cirrhosis with Child-Pugh A score are allowed.
  • History of clinically significant hepatic decompensation as described in the study protocol
  • Presence or history of hepatocellular carcinoma.
  • Medical conditions that may cause non-hepatic increases in ALP (e.g. Paget's disease).
  • Medical conditions that may diminish life expectancy to <2 years, including known cancers.
  • Participant has a positive test for human immunodeficiency virus (HIV) type 1 or 2 at SV1, or participant is known to have tested positive for HIV.
  • Evidence of any other unstable or untreated clinically significant immunological, endocrine, neurological, gastrointestinal, haematologic, psychiatric diseases as evaluated by the investigator; other clinically significant conditions that are not well controlled
  • Known malignancy or history of malignancy within the last 5 years, with the exception of local, successfully treated basal cell carcinoma or in-situ carcinoma of the uterine cervix.
  • Participants with previous exposure to elafibranor
  • ALT and/or AST >5x ULN
  • Albumin <3.0 g/dL at SV1.
  • Platelet count <100,000/microliter.
  • International normalised ratio (INR) >1.3 due to altered hepatic function.
  • Creatine phosphokinase (CPK) >2x ULN during screening period.
  • Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73m2

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Dobro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Double-Blind Period: Elafibranor 80 mg

Participant will receive two tablets per day (one tablet of elafibranor 80 mg + 1 tablet of placebo matching the 120 mg sized tablet) over the 12 weeks in Double-blind period.
Medicamento: Elafibranor 80 mg

Oral Tablet

Outros nomes:
  • GFT505
Medicamento: Placebo Matched to Elafibranor 120 mg

Oral Tablet
Experimental: Double-Blind Period: Elafibranor 120 mg

Participant will receive 2 tablets per day (one tablet of elafibranor 120 mg + 1 tablet of placebo matching the 80 mg sized tablet) over the 12 weeks in Double-blind period.
Medicamento: Elafibranor 120 mg

Oral Tablet

Outros nomes:
  • GFT505
Medicamento: Placebo Matched to Elafibranor 80 mg

Oral Tablet
Comparador de Placebo: Double-Blind Period: Placebo

Participant will receive 2 placebo tablets per day (one matching the 80 mg sized tablet + one matching the 120 mg sized tablet) over the 12 weeks in Double-blind period.
Medicamento: Placebo Matched to Elafibranor 80 mg

Oral Tablet
Experimental: Initial Open-Label Extension (OLE) Period up to OLE Week 96: Elafibranor 120 mg

Participant will receive one tablet per day (elafibranor 120 mg) during the initial 96-weeks Open-Label extension period.
Medicamento: Elafibranor 120 mg

Oral Tablet

Outros nomes:
  • GFT505
Experimental: Open-Label Extension Long-Term (OLE-LT) Period Beyond OLE Week 96: Elafibranor 120 mg

Participant will receive one tablet per day (elafibranor 120 mg) during the optional Open-Label Extension Long-Term period beyond OLE Week 96
Medicamento: Elafibranor 120 mg

Oral Tablet

Outros nomes:
  • GFT505

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Related TEAEs, Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)
Prazo: Double Blind Period: Baseline up to week 12, Initial Open Label Extension (OLE) Period: Baseline up to week 100, Open-Label Extension Long-Term (OLE-LT) Period Beyond OLE Week 96: OLE-LT baseline up to OLE-LT Week 260

An Adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. AESIs are AEs that may not be serious but are of special importance to a particular drug or class of drugs.
Double Blind Period: Baseline up to week 12, Initial Open Label Extension (OLE) Period: Baseline up to week 100, Open-Label Extension Long-Term (OLE-LT) Period Beyond OLE Week 96: OLE-LT baseline up to OLE-LT Week 260
Percentage of Participants With Clinically Significant Changes in Physical Examination Findings
Prazo: Double Blind Period: Baseline up to week 12, Initial OLE Period: Baseline up to week 100

Percentage of participants with clinically significant changes in physical examination findings will be reported. The clinical significance will be decided by the investigator.
Double Blind Period: Baseline up to week 12, Initial OLE Period: Baseline up to week 100
Percentage of Participants With Clinically Significant changes in Laboratory Parameters (blood chemistry, hematology and coagulation)
Prazo: Double Blind Period: Baseline up to week 12, Initial OLE Period: Baseline up to week 100

Percentage of participants with clinically significant change in laboratory parameters (blood chemistry, hematology and coagulation) will be reported. The clinical significance will be decided by the investigator.
Double Blind Period: Baseline up to week 12, Initial OLE Period: Baseline up to week 100
Percentage of Participants With Clinically Significant Changes in Vital Signs
Prazo: Double Blind Period: Baseline up to week 12, Initial OLE Period: Baseline up to week 100

Percentage of participants with clinically significant changes in Vital Signs will be reported. The clinical significance will be decided by the investigator.
Double Blind Period: Baseline up to week 12, Initial OLE Period: Baseline up to week 100
Percentage of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Readings
Prazo: Double Blind Period: Baseline up to week 12, Initial OLE Period: Baseline up to week 100

Percentage of participants with clinically significant changes in ECG readings will be reported. The clinical significance will be decided by the investigator.
Double Blind Period: Baseline up to week 12, Initial OLE Period: Baseline up to week 100

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Porcentagem de participantes com ALP:
Prazo: Período duplo-cego: Semana 12
Período duplo-cego: Semana 12
Porcentagem de participantes que normalizaram ALP
Prazo: Período duplo-cego: Semana 12
Período duplo-cego: Semana 12
Mudança da linha de base nos níveis de albumina na semana 12
Prazo: Linha de base, Semana 12
Linha de base, Semana 12
Alteração da linha de base na pontuação do teste de fibrose hepática aprimorada (ELF)
Prazo: Período duplo-cego: linha de base, semana 12
Período duplo-cego: linha de base, semana 12
Alteração da linha de base nos valores de medição da rigidez do fígado (LSM) avaliados pelo FibroScan® na semana 12
Prazo: Período duplo-cego: linha de base, semana 12
Período duplo-cego: linha de base, semana 12
Mudança da linha de base em outros marcadores séricos de fibrose hepática não invasivos conforme medido por PAI-1, TGF-β, marcador de formação de colágeno tipo V (Pro-C5) e marcador de formação de colágeno tipo III (Pro-C3)
Prazo: Período duplo-cego: linha de base, semana 12
Período duplo-cego: linha de base, semana 12
Mudança da linha de base em Fibrose-4 (FIB-4) e AST para Índice de Razão de Plaquetas (APRI)
Prazo: Período duplo-cego: linha de base, semana 12
Período duplo-cego: linha de base, semana 12
Alteração da linha de base nos níveis de citoqueratina-18 (CK-18) (M65 e M30)
Prazo: Período duplo-cego: linha de base, semana 12
Período duplo-cego: linha de base, semana 12
PK de Elafibranor e seu Metabólito GFT1007: Concentração Máxima (pico) da Droga no Plasma Observada (Cmax)
Prazo: Pré-dose, 0,5 hora (h), 1h, entre 1,5h e 2h, 4h e 6h após a dosagem na Semana 4
Pré-dose, 0,5 hora (h), 1h, entre 1,5h e 2h, 4h e 6h após a dosagem na Semana 4
Relative Change From Baseline in Alkaline Phosphatase Levels (ALP)
Prazo: Double Blind Period: Baseline, Week 12, Initial OLE Period: Baseline, Week 52, Week 96, OLE-LT Period Beyond OLE Week 96: OLE-LT baseline up to OLE-LT Week 260
Double Blind Period: Baseline, Week 12, Initial OLE Period: Baseline, Week 52, Week 96, OLE-LT Period Beyond OLE Week 96: OLE-LT baseline up to OLE-LT Week 260
Percentage of Participants With ≥40% Decrease from Baseline in ALP Levels
Prazo: Double Blind Period: Baseline, Week 12, Initial OLE Period: Baseline, Week 52, Week 96
Double Blind Period: Baseline, Week 12, Initial OLE Period: Baseline, Week 52, Week 96
Absolute Change from Baseline in ALP
Prazo: Double Blind Period: Baseline, Week 12, Initial OLE Period: Baseline, Week 52, Week 96
Double Blind Period: Baseline, Week 12, Initial OLE Period: Baseline, Week 52, Week 96
Change From Baseline in Alanine Transaminase (ALT), Aspartate Transaminase (AST), Gamma-glutamyl transferase (GGT) Levels
Prazo: Baseline, Week 12, Initial OLE-LT Period Beyond OLE Week 96: OLE-LT baseline up to OLE-LT Week 260
Baseline, Week 12, Initial OLE-LT Period Beyond OLE Week 96: OLE-LT baseline up to OLE-LT Week 260
Change From Baseline in 5' Nucleotidase and Fractionated ALP Levels at Week 12
Prazo: Baseline, Week 12
Baseline, Week 12
Change From Baseline in Total bilirubin Levels
Prazo: Baseline, Week 12, Initial OLE-LT Period Beyond OLE Week 96: OLE-LT baseline up to OLE-LT Week 260
Baseline, Week 12, Initial OLE-LT Period Beyond OLE Week 96: OLE-LT baseline up to OLE-LT Week 260
Change From Baseline in Conjugated bilirubin Levels at Week 12
Prazo: Baseline, Week 12
Baseline, Week 12
Number and Percentage of Participants With Clinical Outcome Events During the OLE-LT Period
Prazo: Initial OLE-LT Period Beyond OLE Week 96: OLE-LT baseline up to OLE-LT Week 260
Initial OLE-LT Period Beyond OLE Week 96: OLE-LT baseline up to OLE-LT Week 260
Pharmacokinetics (PK) of Elafibranor and its Metabolite GFT1007: Area Under the Concentration-time Curve Over the Dosing Interval from Time 0 to 24 hours(AUC0-24)
Prazo: Pre-dose, 0.5 hour (h), 1h, between 1.5 hours and 2h, 4h, and 6h after dosing at Week 4

AUC 0-24 will be recorded from the PK blood samples collected.
Pre-dose, 0.5 hour (h), 1h, between 1.5 hours and 2h, 4h, and 6h after dosing at Week 4
PK of Elafibranor and its Metabolite GFT1007: Time to Maximum Observed Drug Concentration (Tmax)
Prazo: Pre-dose, 0.5 hour (h), 1h, between 1.5h and 2h, 4h, and 6h after dosing at Week 4

Tmax will be recorded from the PK blood samples collected.
Pre-dose, 0.5 hour (h), 1h, between 1.5h and 2h, 4h, and 6h after dosing at Week 4
PK of Elafibranor and its Metabolite GFT1007: Total Body Clearance (Cl/F)
Prazo: Double Blind Period: Baseline up to Week 12

Cl/F will be recorded from the PK blood samples collected.
Double Blind Period: Baseline up to Week 12
PK of Elafibranor and its Metabolite GFT1007: Volume of distribution (Vz)
Prazo: Double Blind Period: Baseline up to Week 12

Vz will be recorded from the PK blood samples collected.
Double Blind Period: Baseline up to Week 12

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Ipsen

Investigadores

  • Diretor de estudo: Ipsen Medical, Director, Ipsen

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

29 de dezembro de 2022

Conclusão Primária (Estimado)

23 de setembro de 2031

Conclusão do estudo (Estimado)

23 de setembro de 2031

Datas de inscrição no estudo

Enviado pela primeira vez

22 de novembro de 2022

Enviado pela primeira vez que atendeu aos critérios de CQ

23 de novembro de 2022

Primeira postagem (Real)

25 de novembro de 2022

Atualizações de registro de estudo

Última Atualização Postada (Real)

23 de outubro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

20 de outubro de 2026

Última verificação

1 de outubro de 2026

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • CLIN-60190-453
  • 2022-002695-37 (Número EudraCT)
  • 2024-511370-72-00 (Ctis)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications.

Patient level data will be anonymized and study documents will be redacted to protect the privacy of study participants.

Prazo de Compartilhamento de IPD

Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and/or EU.

Critérios de acesso de compartilhamento IPD

Further details on Ipsen's sharing criteria and process for sharing are available here (https://www.ipsen.com/science/clinical-trials/clinical-data-transparency/).

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Sim

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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