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
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Arizona
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Chandler, Arizona, Forenede Stater, 85224
- Akero Clinical Study Site
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Glendale, Arizona, Forenede Stater, 85306
- Akero Clinical Study Site
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Tucson, Arizona, Forenede Stater, 85711
- Akero Clinical Study Site
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Tucson, Arizona, Forenede Stater, 85712
- Akero Clinical Study Site
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Arkansas
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North Little Rock, Arkansas, Forenede Stater, 72117
- Akero Clinical Study Site
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California
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Fresno, California, Forenede Stater, 93720
- Akero Clinical Study Site
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Long Beach, California, Forenede Stater, 90808
- Akero Clinical Study Site
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Los Angeles, California, Forenede Stater, 90036
- Akero Clinical Study Site
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Pasadena, California, Forenede Stater, 91105
- Akero Clinical Study Site
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Colorado
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Englewood, Colorado, Forenede Stater, 80113
- Akero Clinical Study Site
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Florida
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Clearwater, Florida, Forenede Stater, 33761
- Akero Clinical Study Site
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Fort Myers, Florida, Forenede Stater, 33907
- Akero Clinical Study Site
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Fort Myers, Florida, Forenede Stater, 33912
- Akero Clinical Study Site
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Hialeah Gardens, Florida, Forenede Stater, 33016
- Akero Clinical Study Site
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Lakewood Rch, Florida, Forenede Stater, 34211
- Akero Clinical Study Site
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Miami Lakes, Florida, Forenede Stater, 33016
- Akero Clinical Study Site
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Ocala, Florida, Forenede Stater, 34471
- Akero Clinical Study Site
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Sarasota, Florida, Forenede Stater, 34240
- Akero Clinical Study Site
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Indiana
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South Bend, Indiana, Forenede Stater, 46635
- Akero Clinical Study Site
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Kansas
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Topeka, Kansas, Forenede Stater, 66606
- Akero Clinical Study Site
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Louisiana
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Bastrop, Louisiana, Forenede Stater, 71220
- Akero Clinical Study Site
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Marrero, Louisiana, Forenede Stater, 70072
- Akero Clinical Study Site
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Nevada
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Las Vegas, Nevada, Forenede Stater, 89109
- Akero Clinical Study Site
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North Carolina
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Concord, North Carolina, Forenede Stater, 28027
- Akero Clinical Study Site
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Fayetteville, North Carolina, Forenede Stater, 28304
- Akero Clinical Study Site
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Morehead City, North Carolina, Forenede Stater, 28557
- Akero Clinical Study Site
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Ohio
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Springboro, Ohio, Forenede Stater, 45066
- Akero Clinical Study Site
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Westlake, Ohio, Forenede Stater, 44145
- Akero Clinical Study Site
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South Carolina
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Greenville, South Carolina, Forenede Stater, 29605
- Akero Clinical Study Site
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Greenwood, South Carolina, Forenede Stater, 29646
- Akero Clinical Study Site
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Summerville, South Carolina, Forenede Stater, 29485
- Akero Clinical Study Site
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Tennessee
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Nashville, Tennessee, Forenede Stater, 37211
- Akero Clinical Study Site
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Texas
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Austin, Texas, Forenede Stater, 78746
- Akero Clinical Study Site
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Dallas, Texas, Forenede Stater, 75246
- Akero Clinical Study Site
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Edinburg, Texas, Forenede Stater, 78504
- Akero Clinical Study Site
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Edinburg, Texas, Forenede Stater, 78539
- Akero Clinical Study Site
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Fort Worth, Texas, Forenede Stater, 75044
- Akero Clinical Study Site
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Fort Worth, Texas, Forenede Stater, 76104
- Akero Clinical Study Site
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Houston, Texas, Forenede Stater, 77030
- Akero Clinical Study Site
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Houston, Texas, Forenede Stater, 77079
- Akero Clinical Study Site
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San Antonio, Texas, Forenede Stater, 78215
- Akero Clinical Study Site
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Waco, Texas, Forenede Stater, 76710
- Akero Clinical Study Site
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Webster, Texas, Forenede Stater, 77598
- Akero Clinical Study Site
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Wichita Falls, Texas, Forenede Stater, 76301
- Akero Clinical Study Site
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Utah
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Ogden, Utah, Forenede Stater, 84405
- Akero Clinical Study Site
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Virginia
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Richmond, Virginia, Forenede Stater, 23298
- Akero Clinical Study Site
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Mexico City, Mexico
- Akero Clinical Study Site
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Monterrey, Mexico
- Akero Clinical Study Site
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San Juan, Puerto Rico, 00927
- Akero Clinical Study Site
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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 |
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Placebo komparator: Placebo (hovedundersøgelse)
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Placebo
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Eksperimentel: EFX 28 mg (hovedundersøgelse)
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Undersøgelseslægemiddel, Efroxifermin
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Eksperimentel: EFX 50 mg (hovedundersøgelse)
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Undersøgelseslægemiddel, Efroxifermin
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Eksperimentel: EFX 50 mg (kohorte D)
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Undersøgelseslægemiddel, Efroxifermin
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Placebo komparator: Placebo (kohorte D)
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Placebo
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Main: Change From Baseline in Fibrosis With no Worsening Steatohepatitis Assessed by NASH CRN System
Tidsramme: Week 36
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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.
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Week 36
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Main: Resolution of NASH Assessed by the NASH CRN System
Tidsramme: Week 36, Week 96
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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.
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Week 36, Week 96
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Main: Fibrosis Improvement and Resolution of NASH Assessed by the NASH CRN System
Tidsramme: Week 36, Week 96
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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
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Week 36, Week 96
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Main: Change From Baseline in Fibrosis With no Worsening of Steatohepatitis Assessed by the NASH CRN System
Tidsramme: Week 96
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Proportion of subjects who achieve ≥ 1 stage improvement in fibrosis (based on NASH CRN fibrosis score) and no worsening of steatohepatitis at Week 96
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Week 96
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Main: Change From Baseline in Fibrosis by NASH CRN System
Tidsramme: Week 36, Week 96
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Proportion of subjects who achieve ≥ 1 stage improvement in fibrosis (based on NASH CRN fibrosis score) at Week 36 and Week 96
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Week 36, Week 96
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Main: Change From Baseline in S-Pro-C3
Tidsramme: Week 36, Week 48, Week 72, Week 96
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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.
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Week 36, Week 48, Week 72, Week 96
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Main: Change From Baseline in Enhanced Liver Fibrosis (ELF) Score
Tidsramme: Week 36, Week 48, Week 72, Week 96
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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.
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Week 36, Week 48, Week 72, Week 96
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Main: Change From Baseline in Liver Stiffness Assessed by Liver Elastography (kPa)
Tidsramme: Week 36, Week 48, Week 72, Week 96
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Change from baseline in liver stiffness assessed by liver elastography (kPa)
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Week 36, Week 48, Week 72, Week 96
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Main: Change From Baseline in Lipoproteins
Tidsramme: Week 36, Week 48, Week 72, Week 96
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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)
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Week 36, Week 48, Week 72, Week 96
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Main: Change From Baseline in HbA1c (%)
Tidsramme: Week 36, Week 48, Week 72, Week 96
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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
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Week 36, Week 48, Week 72, Week 96
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Main: Change From Baseline in C-peptide (ug/L)
Tidsramme: Week 36, Week 48, Week 72, Week 96
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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.
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Week 36, Week 48, Week 72, Week 96
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Main: Change From Baseline in Adiponectin (mg/L)
Tidsramme: Week 36, Week 48, Week 72, Week 96
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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.
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Week 36, Week 48, Week 72, Week 96
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Main: Change From Baseline in Insulin (mIU/L)
Tidsramme: Week 36, Week 48, Week 72, Week 96
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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.
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Week 36, Week 48, Week 72, Week 96
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Main: Change From Baseline in HOMA-IR
Tidsramme: Week 36, Week 48, Week 72, Week 96
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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.
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Week 36, Week 48, Week 72, Week 96
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Main: Change From Baseline in Body Weight
Tidsramme: Week 36, Week 48, Week 96
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Change from baseline in body weight (kg)
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Week 36, Week 48, Week 96
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Main: Number of Participants With ADA Against EFX
Tidsramme: Through Week 96
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Detect and measure ADA against EFX
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Through Week 96
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Main: To Assess the Safety and Tolerability of EFX
Tidsramme: Through Week 96
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Safety and tolerability will be assessed through the reporting of AEs, clinical laboratory tests, ECGs, ultrasounds, vital sign assessments, and concomitant medication usage
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Through Week 96
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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
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Safety and tolerability will be assessed through the reporting of AEs, clinical laboratory assessments, ECGs, ultrasounds, vital sign assessments, and concomitant medication usage
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Through Week 12
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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.
Generelle publikationer
- Noureddin M, Rinella ME, Chalasani NP, Neff GW, Lucas KJ, Rodriguez ME, Rudraraju M, Patil R, Behling C, Burch M, Chan DC, Tillman EJ, Zari A, de Temple B, Shringarpure R, Jain M, Rolph T, Cheng A, Yale K. Efruxifermin in Compensated Liver Cirrhosis Caused by MASH. N Engl J Med. 2025 Jun 26;392(24):2413-2424. doi: 10.1056/NEJMoa2502242. Epub 2025 May 9.
- Harrison SA, Frias JP, Lucas KJ, Reiss G, Neff G, Bollepalli S, Su Y, Chan D, Tillman EJ, Moulton A, de Temple B, Zari A, Shringarpure R, Rolph T, Cheng A, Yale K. Safety and Efficacy of Efruxifermin in Combination With a GLP-1 Receptor Agonist in Patients With NASH/MASH and Type 2 Diabetes in a Randomized Phase 2 Study. Clin Gastroenterol Hepatol. 2025 Jan;23(1):103-113. doi: 10.1016/j.cgh.2024.02.022. Epub 2024 Mar 4.
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
Yderligere relevante MeSH-vilkår
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
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Ja
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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 .