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En studie for å vurdere sikkerhet og effektivitet av Elafibranor hos voksne deltakere med primær skleroserende kolangitt. (ELMWOOD)

20. oktober 2026 oppdatert av: Ipsen

En fase II, multisenter, dobbeltblind, randomisert, placebokontrollert studie og langtidsforlengelse for åpen etikett for å evaluere sikkerheten og effekten av Elafibranor hos voksne deltakere med primær skleroserende kolangitt (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.

Studieoversikt

Status

Aktiv, ikke rekrutterende

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

68

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 75 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Legemiddel: Elafibranor 80 mg

Oral Tablet

Andre navn:
  • GFT505
Legemiddel: Placebo Matched to Elafibranor 120 mg

Oral Tablet
Eksperimentell: 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.
Legemiddel: Elafibranor 120 mg

Oral Tablet

Andre navn:
  • GFT505
Legemiddel: Placebo Matched to Elafibranor 80 mg

Oral Tablet
Placebo komparator: 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.
Legemiddel: Placebo Matched to Elafibranor 80 mg

Oral Tablet
Eksperimentell: 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.
Legemiddel: Elafibranor 120 mg

Oral Tablet

Andre navn:
  • GFT505
Eksperimentell: 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
Legemiddel: Elafibranor 120 mg

Oral Tablet

Andre navn:
  • GFT505

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Related TEAEs, Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Prosentandel av deltakere med ALP:
Tidsramme: Dobbeltblindperiode: uke 12
Dobbeltblindperiode: uke 12
Prosentandel av deltakere som normaliserte ALP
Tidsramme: Dobbeltblindperiode: uke 12
Dobbeltblindperiode: uke 12
Endring fra baseline i albuminnivåer i uke 12
Tidsramme: Baseline, uke 12
Baseline, uke 12
Endring fra baseline i forbedret leverfibrose (ELF) testscore
Tidsramme: Dobbeltblindperiode: Baseline, uke 12
Dobbeltblindperiode: Baseline, uke 12
Endring fra baseline i leverstivhetsmåling (LSM) verdier vurdert av FibroScan® i uke 12
Tidsramme: Dobbeltblindperiode: Baseline, uke 12
Dobbeltblindperiode: Baseline, uke 12
Endring fra baseline i andre ikke-invasive hepatisk fibrose-serummarkører målt ved PAI-1, TGF-β, markør for type V kollagendannelse (Pro-C5) og markør for type III kollagendannelse (Pro-C3)
Tidsramme: Dobbeltblindperiode: Baseline, uke 12
Dobbeltblindperiode: Baseline, uke 12
Endring fra baseline i fibrose-4 (FIB-4) og AST til blodplateforholdsindeks (APRI)
Tidsramme: Dobbeltblindperiode: Baseline, uke 12
Dobbeltblindperiode: Baseline, uke 12
Endring fra baseline i Cytokeratin-18 (CK-18) (M65 og M30) nivåer
Tidsramme: Dobbeltblindperiode: Baseline, uke 12
Dobbeltblindperiode: Baseline, uke 12
PK av Elafibranor og dets metabolitt GFT1007: Maksimal (topp) observert plasmalegemiddelkonsentrasjon (Cmax)
Tidsramme: Fordose, 0,5 time (t), 1 time, mellom 1,5 og 2 timer, 4 timer og 6 timer etter dosering ved uke 4
Fordose, 0,5 time (t), 1 time, mellom 1,5 og 2 timer, 4 timer og 6 timer etter dosering ved uke 4
Relative Change From Baseline in Alkaline Phosphatase Levels (ALP)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Baseline, Week 12
Baseline, Week 12
Change From Baseline in Total bilirubin Levels
Tidsramme: 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
Tidsramme: Baseline, Week 12
Baseline, Week 12
Number and Percentage of Participants With Clinical Outcome Events During the OLE-LT Period
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Ipsen

Etterforskere

  • Studieleder: Ipsen Medical, Director, Ipsen

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

29. desember 2022

Primær fullføring (Antatt)

23. september 2031

Studiet fullført (Antatt)

23. september 2031

Datoer for studieregistrering

Først innsendt

22. november 2022

Først innsendt som oppfylte QC-kriteriene

23. november 2022

Først lagt ut (Faktiske)

25. november 2022

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

23. oktober 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

20. oktober 2026

Sist bekreftet

1. oktober 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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.

IPD-delingstidsramme

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.

Tilgangskriterier for IPD-deling

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

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere