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En undersøgelse af efroxifermin hos personer med kompenseret skrumpelever på grund af ikke-alkoholisk Steatohepatitis (NASH) (symmetri)

23. juni 2026 opdateret af: Akero Therapeutics, Inc

En fase 2b, randomiseret, dobbeltblind, placebokontrolleret undersøgelse, der evaluerer sikkerheden og effektiviteten af ​​efroxifermin hos forsøgspersoner med kompenseret skrumpelever på grund af ikke-alkoholisk Steatohepatitis (NASH)

Dette er en multicenter-evaluering af efroxifermin (EFX) i et randomiseret, dobbeltblindt, placebokontrolleret studie i cirrose forsøgspersoner med biopsi-bevist F4-kompenseret NASH.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

213

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Arizona
      • Chandler, Arizona, Forenede Stater, 85224
        • Akero Clinical Study Site
      • Glendale, Arizona, Forenede Stater, 85306
        • Akero Clinical Study Site
      • Tucson, Arizona, Forenede Stater, 85711
        • Akero Clinical Study Site
      • Tucson, Arizona, Forenede Stater, 85712
        • Akero Clinical Study Site
    • Arkansas
      • North Little Rock, Arkansas, Forenede Stater, 72117
        • Akero Clinical Study Site
    • California
      • Fresno, California, Forenede Stater, 93720
        • Akero Clinical Study Site
      • Long Beach, California, Forenede Stater, 90808
        • Akero Clinical Study Site
      • Los Angeles, California, Forenede Stater, 90036
        • Akero Clinical Study Site
      • Pasadena, California, Forenede Stater, 91105
        • Akero Clinical Study Site
    • Colorado
      • Englewood, Colorado, Forenede Stater, 80113
        • Akero Clinical Study Site
    • Florida
      • Clearwater, Florida, Forenede Stater, 33761
        • Akero Clinical Study Site
      • Fort Myers, Florida, Forenede Stater, 33907
        • Akero Clinical Study Site
      • Fort Myers, Florida, Forenede Stater, 33912
        • Akero Clinical Study Site
      • Hialeah Gardens, Florida, Forenede Stater, 33016
        • Akero Clinical Study Site
      • Lakewood Rch, Florida, Forenede Stater, 34211
        • Akero Clinical Study Site
      • Miami Lakes, Florida, Forenede Stater, 33016
        • Akero Clinical Study Site
      • Ocala, Florida, Forenede Stater, 34471
        • Akero Clinical Study Site
      • Sarasota, Florida, Forenede Stater, 34240
        • Akero Clinical Study Site
    • Indiana
      • South Bend, Indiana, Forenede Stater, 46635
        • Akero Clinical Study Site
    • Kansas
      • Topeka, Kansas, Forenede Stater, 66606
        • Akero Clinical Study Site
    • Louisiana
      • Bastrop, Louisiana, Forenede Stater, 71220
        • Akero Clinical Study Site
      • Marrero, Louisiana, Forenede Stater, 70072
        • Akero Clinical Study Site
    • Nevada
      • Las Vegas, Nevada, Forenede Stater, 89109
        • Akero Clinical Study Site
    • North Carolina
      • Concord, North Carolina, Forenede Stater, 28027
        • Akero Clinical Study Site
      • Fayetteville, North Carolina, Forenede Stater, 28304
        • Akero Clinical Study Site
      • Morehead City, North Carolina, Forenede Stater, 28557
        • Akero Clinical Study Site
    • Ohio
      • Springboro, Ohio, Forenede Stater, 45066
        • Akero Clinical Study Site
      • Westlake, Ohio, Forenede Stater, 44145
        • Akero Clinical Study Site
    • South Carolina
      • Greenville, South Carolina, Forenede Stater, 29605
        • Akero Clinical Study Site
      • Greenwood, South Carolina, Forenede Stater, 29646
        • Akero Clinical Study Site
      • Summerville, South Carolina, Forenede Stater, 29485
        • Akero Clinical Study Site
    • Tennessee
      • Nashville, Tennessee, Forenede Stater, 37211
        • Akero Clinical Study Site
    • Texas
      • Austin, Texas, Forenede Stater, 78746
        • Akero Clinical Study Site
      • Dallas, Texas, Forenede Stater, 75246
        • Akero Clinical Study Site
      • Edinburg, Texas, Forenede Stater, 78504
        • Akero Clinical Study Site
      • Edinburg, Texas, Forenede Stater, 78539
        • Akero Clinical Study Site
      • Fort Worth, Texas, Forenede Stater, 75044
        • Akero Clinical Study Site
      • Fort Worth, Texas, Forenede Stater, 76104
        • Akero Clinical Study Site
      • Houston, Texas, Forenede Stater, 77030
        • Akero Clinical Study Site
      • Houston, Texas, Forenede Stater, 77079
        • Akero Clinical Study Site
      • San Antonio, Texas, Forenede Stater, 78215
        • Akero Clinical Study Site
      • Waco, Texas, Forenede Stater, 76710
        • Akero Clinical Study Site
      • Webster, Texas, Forenede Stater, 77598
        • Akero Clinical Study Site
      • Wichita Falls, Texas, Forenede Stater, 76301
        • Akero Clinical Study Site
    • Utah
      • Ogden, Utah, Forenede Stater, 84405
        • Akero Clinical Study Site
    • Virginia
      • Richmond, Virginia, Forenede Stater, 23298
        • Akero Clinical Study Site
      • Mexico City, Mexico
        • Akero Clinical Study Site
      • Monterrey, Mexico
        • Akero Clinical Study Site
      • San Juan, Puerto Rico, 00927
        • Akero Clinical Study Site

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

  • Hanner og ikke-gravide, ikke-ammende kvinder mellem 18-75 år inklusive, baseret på datoen for underskrivelse af informeret samtykke.
  • Kun hovedundersøgelse: Tidligere historie eller tilstedeværelse af type 2-diabetes eller 2 ud af 4 komponenter af metabolisk syndrom (fedme, dyslipidæmi, forhøjet blodtryk, forhøjet fastende glukose).
  • Kun hovedundersøgelse: Biopsi-bevist kompenseret cirrhose på grund af NASH.
  • Kun kohorte D: Diagnose af type 2-diabetes
  • Kun kohorte D: Brug af GLP-1R-agonist i mindst 90 dage
  • Kun kohorte D: Biopsi-bevist leverfibrose stadier 1, 2 eller 3

Ekskluderingskriterier:

  • Kun hovedundersøgelse: Vægttab > 10 % i de 90 dage før screening indtil randomisering eller fra tidspunktet for indsamling af leverbiopsien brugt til at vurdere forsøgspersonens egnethed indtil randomisering, alt efter hvad der er længst.
  • Type 1 diabetes eller ukontrolleret type 2 diabetes
  • Kun kohorte D: Vægttab > 5 % i de 90 dage før screening
  • Kun kohorte D: Tilstedeværelse af skrumpelever på leverbiopsi

Andre inklusions- og eksklusionskriterier kan være gældende

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: Placebo (hovedundersøgelse)
Placebo
Eksperimentel: EFX 28 mg (hovedundersøgelse)
Undersøgelseslægemiddel, Efroxifermin
Eksperimentel: EFX 50 mg (hovedundersøgelse)
Undersøgelseslægemiddel, Efroxifermin
Eksperimentel: EFX 50 mg (kohorte D)
Undersøgelseslægemiddel, Efroxifermin
Placebo komparator: Placebo (kohorte D)
Placebo

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Main: Change From Baseline in Fibrosis With no Worsening Steatohepatitis Assessed by NASH CRN System
Tidsramme: Week 36
Proportion of subjects who achieve ≥ 1 stage improvement in fibrosis (based on NASH CRN fibrosis score) and no worsening of steatohepatitis at Week 36. No worsening of steatohepatitis was defined as no increase in score for any of the 3 components of NAS. The evaluation of the NAS endpoint was calculated using the following 3 categorical features: steatosis [0-3], lobular inflammation [0-3], and hepatocellular ballooning [0-2]. NAS was derived as the unweighted sum of steatosis, lobular inflammation, and hepatocellular ballooning scores.
Week 36

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Main: Resolution of NASH Assessed by the NASH CRN System
Tidsramme: Week 36, Week 96
Proportion of subjects who achieve NASH resolution (defined as a NAS of 0-1 for inflammation and 0 for ballooning) as determined by the NASH CRN criteria at Week 36 and Week 96.
Week 36, Week 96
Main: Fibrosis Improvement and Resolution of NASH Assessed by the NASH CRN System
Tidsramme: Week 36, Week 96
Proportion of subjects who achieve NASH resolution (defined as a NAS of 0-1 for inflammation and 0 for ballooning) and ≥ 1 stage improvement in fibrosis (based on NASH CRN fibrosis score) at Week 36 and Week 96
Week 36, Week 96
Main: Change From Baseline in Fibrosis With no Worsening of Steatohepatitis Assessed by the NASH CRN System
Tidsramme: Week 96
Proportion of subjects who achieve ≥ 1 stage improvement in fibrosis (based on NASH CRN fibrosis score) and no worsening of steatohepatitis at Week 96
Week 96
Main: Change From Baseline in Fibrosis by NASH CRN System
Tidsramme: Week 36, Week 96
Proportion of subjects who achieve ≥ 1 stage improvement in fibrosis (based on NASH CRN fibrosis score) at Week 36 and Week 96
Week 36, Week 96
Main: Change From Baseline in S-Pro-C3
Tidsramme: Week 36, Week 48, Week 72, Week 96
Change from baseline in Serum Pro-C3 (N-terminal type III collagen propeptide), a biomarker of type III collagen formation reflecting fibrogenesis, measured in ug/L.
Week 36, Week 48, Week 72, Week 96
Main: Change From Baseline in Enhanced Liver Fibrosis (ELF) Score
Tidsramme: Week 36, Week 48, Week 72, Week 96
ELF score is a composite serum biomarker score derived from HA, PIIINP, and TIMP-1 concentrations. Scores range approximately from 6 to 16, with higher scores indicating greater liver fibrosis severity.
Week 36, Week 48, Week 72, Week 96
Main: Change From Baseline in Liver Stiffness Assessed by Liver Elastography (kPa)
Tidsramme: Week 36, Week 48, Week 72, Week 96
Change from baseline in liver stiffness assessed by liver elastography (kPa)
Week 36, Week 48, Week 72, Week 96
Main: Change From Baseline in Lipoproteins
Tidsramme: Week 36, Week 48, Week 72, Week 96
Change from baseline in Triglycerides (mg/dL), total cholesterol (mg/dL), high-density lipoprotein (HDL-C) (mg/dL), non-HDL-C (mg/dL), and low-density lipoprotein (LDL-C) (mg/dL)
Week 36, Week 48, Week 72, Week 96
Main: Change From Baseline in HbA1c (%)
Tidsramme: Week 36, Week 48, Week 72, Week 96
Glycated hemoglobin (HbA1c), expressed as a percentage, reflects average blood glucose levels over approximately 2 to 3 months and is used as a measure of glycemic control
Week 36, Week 48, Week 72, Week 96
Main: Change From Baseline in C-peptide (ug/L)
Tidsramme: Week 36, Week 48, Week 72, Week 96
C-peptide reflects endogenous insulin secretion and pancreatic beta-cell function. Change from baseline represents the difference between the post-baseline value and the baseline measurement.
Week 36, Week 48, Week 72, Week 96
Main: Change From Baseline in Adiponectin (mg/L)
Tidsramme: Week 36, Week 48, Week 72, Week 96
Adiponectin is involved in glucose and lipid metabolism and is used as a marker of metabolic status. Change from baseline represents the difference between the post-baseline value and the baseline measurement.
Week 36, Week 48, Week 72, Week 96
Main: Change From Baseline in Insulin (mIU/L)
Tidsramme: Week 36, Week 48, Week 72, Week 96
Insulin reflects endogenous insulin levels measured after a period of fasting. Change from baseline represents the difference between the post-baseline value and the baseline measurement.
Week 36, Week 48, Week 72, Week 96
Main: Change From Baseline in HOMA-IR
Tidsramme: Week 36, Week 48, Week 72, Week 96
HOMA-IR has no fixed upper limit. Values near 1 are typically observed in individuals with normal insulin sensitivity, while progressively higher values indicate increasing insulin resistance. The clinical significance of a given value may vary depending on the population and assay methodology. Change from baseline represents the difference between the post-baseline value and the baseline measurement.
Week 36, Week 48, Week 72, Week 96
Main: Change From Baseline in Body Weight
Tidsramme: Week 36, Week 48, Week 96
Change from baseline in body weight (kg)
Week 36, Week 48, Week 96
Main: Number of Participants With ADA Against EFX
Tidsramme: Through Week 96
Detect and measure ADA against EFX
Through Week 96
Main: To Assess the Safety and Tolerability of EFX
Tidsramme: Through Week 96
Safety and tolerability will be assessed through the reporting of AEs, clinical laboratory tests, ECGs, ultrasounds, vital sign assessments, and concomitant medication usage
Through Week 96
Cohort D: To Assess the Safety and Tolerability of EFX Compared to Placebo When Added to an Existing GLP-1R Agonist in Subjects With Type 2 Diabetes and Liver Fibrosis Due to NASH
Tidsramme: Through Week 12
Safety and tolerability will be assessed through the reporting of AEs, clinical laboratory assessments, ECGs, ultrasounds, vital sign assessments, and concomitant medication usage
Through Week 12

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

30. juli 2021

Primær færdiggørelse (Faktiske)

15. december 2023

Studieafslutning (Faktiske)

28. august 2025

Datoer for studieregistrering

Først indsendt

29. juli 2021

Først indsendt, der opfyldte QC-kriterier

2. september 2021

Først opslået (Faktiske)

9. september 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

21. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • AK-US-001-0103

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .