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NCT06215716ClinicalTrials.gov

A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis

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This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in subjects with non-cirrhotic NASH/MASH and fibrosis stage 2 or 3 (F2 or F3). The study will enroll subjects in two cohorts for a total samples…

Phase 31.650 Teilnehmende gesucht356 Studienzentren18 Länder

Kategorien

Gastroenterologie und Hepatologie73%Endokrin und metabolisch27%

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How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

  • Registered after enrolment began (about 52 days after the recorded start)First posted 2024-01-22; recorded start 2023-12-01
  • Has a defined primary outcomeA primary outcome measure is listed in the record
  • The primary outcome states a time frameThe primary outcome measure records a time frame
  • Participants are randomly assignedAllocation is recorded as randomised
  • Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
  • Uses blinding (masking)A masking level is recorded in the record
  • An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
  • Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
  • A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
  • No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
  • Sponsor has 4 other studies in this databaseCounted from the lead sponsor named in the record (Akero Therapeutics, Inc)
  • No posted results from this sponsor are in this database yetBased on the sponsor’s studies in this database
  • The record lists 2 conditions.
  • Lead sponsor type recorded as: industry.
  • Intervention regulatory context: investigational, within a phased regulatory pathway.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourSTRONG

A strong methodological design for a phase 3 study, judged from its ClinicalTrials.gov record.

How this score is built
  • Randomised allocation20/20

    Participants are randomly allocated between arms

  • Blinding20/20

    Quadruple-blind

  • Control arm13/15

    Placebo / sham control arm

  • Primary-outcome specificity10/10

    Named primary outcome with a defined time frame

  • Endpoint type3/10

    Surrogate or intermediate endpoint (conservative default)

  • Multi-centre8/8

    Multi-centre: 356 sites

  • Data monitoring committee0/7

    Data monitoring committee not stated in the record

  • Prospective registration3/5

    Registered within 30 days of the study start

  • Protocol / SAP posted0/5

    No protocol or SAP posted to the registry

ScaleLARGE

A large study, international in scope: 1,650 participants (target), run at 356 sites, across 18 countries.

How this score is built
  • Enrolment32/40

    1,650 participants (target)

  • Site count25/25

    356 sites

  • Country count15/15

    18 countries

  • Planned duration10/10

    Planned over about 112 months

  • Sponsor scale2/10

    Akero Therapeutics, Inc has led 5 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built
  • Investigator standing0/100

    No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

Zusammenfassung

This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in subjects with non-cirrhotic NASH/MASH and fibrosis stage 2 or 3 (F2 or F3). The study will enroll subjects in two cohorts for a total samples size of 1650 subjects.

This is a Phase 3, multi-center, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of efruxifermin (EFX) in subjects with non-cirrhotic nonalcoholic steatohepatitis (NASH)/metabolic dysfunction-associated steatohepatitis (MASH) and fibrosis stage 2 or 3 (F2 or F3). Approximately 1,650 subjects will be enrolled into 2 cohorts. Cohort 1 will enroll approximately 750 subjects with biopsy-confirmed NASH/MASH and fibrosis stage F2 or F3. Subjects in Cohort 1 will undergo evaluation of histologic efficacy endpoints at Week 52. Cohort 2 will enroll approximately 900 subjects with biopsy-confirmed fibrosis stage F3. Subjects in Cohort 2 may enroll regardless of NAFLD Activity Score (NAS). Subjects in Cohort 2 will undergo liver biopsy assessment at Week 96. Eligible subjects will be randomized in a 1:1:1 ratio to receive: * EFX 28 mg administered subcutaneously once weekly * EFX 50 mg administered subcutaneously once weekly * Placebo administered subcutaneously once weekly Subjects will participate in: * a screening period of up to 12 weeks, * a 52-week primary histology endpoint treatment period (Cohort 1), * a 96-week secondary histology endpoint period (Cohort 2), * long-term treatment and clinical outcomes follow-up for up to approximately -240 weeks total treatment duration, and * a follow-up visit approximately 30 days after the last dose of study drug. The study will evaluate the effects of EFX compared with placebo on histologic improvement in NASH/MASH, fibrosis regression, noninvasive markers of liver fibrosis, biochemistry markers of lipidic and glycemic metabolism, liver-related clinical outcomes, and long-term safety. Clinical outcomes assessments include evaluation of liver-related events and all-cause mortality. Key secondary and long-term outcome assessments include evaluation of fibrosis progression, liver stiffness by FibroScan, and Enhanced Liver Fibrosis (ELF) score at prespecified time points including Weeks 96 and 240. Subjects who discontinue study drug may continue study assessments according to the protocol schedule to support long-term efficacy and safety evaluations.

Erkrankungen

  • NASH With Fibrosis
  • MASH With Fibrosis

Eignung

GeschlechtAlle
Alter18 Years – 80 Years
Gesunde FreiwilligeNein

Eignung im Wortlaut des Registers

Inclusion Criteria: * Males and non-pregnant, non-lactating females between 18 - 80 years of age inclusive, based on the date of the screening visit. * Previous history or presence of 2 out of 4 components of metabolic syndrome (obesity, dyslipidemia, elevated blood pressure, elevated fasting glucose) or type 2 diabetes. * Cohort 1: Biopsy-proven NASH/MASH. Must have had a liver biopsy obtained ≤ 180 days prior to screening with fibrosis stage 2 or 3 and a non-alcoholic fatty liver disease (NAFLD) activity score (NAS) of ≥ 4 with at least a score of 1 in each of the following NAS components: * Steatosis (scored 0 to 3), * Ballooning degeneration (scored 0 to 2), and * Lobular inflammation (scored 0 to 3). * Cohort 2: Biopsy-proven fibrosis stage 3. Must have had a liver biopsy obtained ≤ 180 days prior to screening. Subjects with NAS \<4 may be enrolled and are not required to meet 1 point in each of the components of NAS. Exclusion Criteria: * Other causes of liver disease based on medical history and/or liver histology and/or central laboratory results. * Presence of cirrhosis on liver biopsy (fibrosis stage 4). * Type 1 or uncontrolled Type 2 diabetes. Other inclusion and exclusion criteria may apply.

Eignung in einfachen Aussagen

Die Kriterien dieses Eintrags wurden noch nicht in einzelne Aussagen aufgeschlüsselt. Der Registertext oben ist vollständig und ist die maßgebliche Fassung.

Studiendesign

StudientypInterventionell
PhasePhase 3
ZuteilungRandomisiert
InterventionsmodellPARALLEL
Primäres ZielTREATMENT
VerblindungQUADRUPLE (4)
Teilnahme1.650 Teilnehmende gesucht

Sponsor und Mitwirkende

  • Akero Therapeutics, Inc Sponsor

Studienarme und Interventionen

  • EFX 28 mgEXPERIMENTAL
  • EFX 50 mgEXPERIMENTAL
  • PlaceboPLACEBO_COMPARATOR

Interventionen

  • Arzneimittel Efruxifermin

    Administered by subcutaneous injection

  • Arzneimittel Placebo

    Administered by subcutaneous injection

Endpunkte

  1. Primärer Endpunkt

    Cohort 1 Only: Resolution of NASH/MASH and a ≥ 1 stage improvement in fibrosis

    Based on NAS (scored by 0-3 for steatosis, 0-3 for inflammation, and 0-2 for ballooning) and NASH CRN fibrosis score (scored by a fibrosis score of 0-4, where 0 = no fibrosis, 1 = perisinusoidal or periportal fibrosis, 2 = perisinusoidal and portal/periportal fibrosis, 3 = bridging fibrosis, 4 = cirrhosis)

    Zeitrahmen 52 Weeks

  2. Primärer Endpunkt

    Event-free survival

    Based on time from randomization to the first clinical event including evidence of disease progression, liver decompensation events, liver transplantation or eligibility for liver transplantation, and all-cause mortality.

    Zeitrahmen 240 Weeks

  3. Sekundärer Endpunkt

    Change from baseline of non-invasive markers of liver fibrosis: ELF score components (TIMP-1, HA, PIIINP, Pro-C3)

    Tissue inhibitor of metalloproteinase-1 \[TIMP-1\], hyaluronic acid \[HA\], amino terminal pro-peptide of type 3 procollagen \[PIIINP\]), and propeptide of type 3 procollagen (Pro-C3)

    Zeitrahmen 52 Weeks

  4. Sekundärer Endpunkt

    Cohort 1 Only: Resolution of NASH/MASH and no worsening of fibrosis

    Based on NAS (scored by 0-3 for steatosis, 0-3 for inflammation, and 0-2 for ballooning) and NASH CRN fibrosis score (scored by a fibrosis score of 0-4, where 0 = no fibrosis, 1 = perisinusoidal or periportal fibrosis, 2 = perisinusoidal and portal/periportal fibrosis, 3 = bridging fibrosis, 4 = cirrhosis)

    Zeitrahmen 52 Weeks

  5. Sekundärer Endpunkt

    Cohort 1 Only: ≥ 1 stage improvement in fibrosis and no worsening of steatohepatitis

    Based on NAS (scored by 0-3 for steatosis, 0-3 for inflammation, and 0-2 for ballooning) and NASH CRN fibrosis score (scored by a fibrosis score of 0-4, where 0 = no fibrosis, 1 = perisinusoidal or periportal fibrosis, 2 = perisinusoidal and portal/periportal fibrosis, 3 = bridging fibrosis, 4 = cirrhosis)

    Zeitrahmen 52 Weeks

  6. Sekundärer Endpunkt

    Change from baseline of non-invasive markers of liver fibrosis: ELF score

    The ELF score measures the severity of liver fibrosis and estimates the risk of disease progression to cirrhosis or liver-related events, with higher scores indicating higher liver fibrosis level and higher risk of disease progression.

    Zeitrahmen 52 Weeks

  7. Sekundärer Endpunkt

    Change from baseline in non-invasive markers of liver fibrosis: ELF score

    The ELF score measures the severity of liver fibrosis and estimates the risk of disease progression to cirrhosis or liver-related events, with higher scores indicating higher liver fibrosis level and higher risk of disease progression.

    Zeitrahmen 96 Weeks, 240 Weeks

  8. Sekundärer Endpunkt

    Change from baseline in non-invasive markers of liver fibrosis: ELF score components: TIMP-1, HA, PIIINP, Pro-C3

    The ELF score measures the severity of liver fibrosis and estimates the risk of disease progression to cirrhosis or liver-related events, with higher scores indicating higher liver fibrosis level and higher risk of disease progression.

    Zeitrahmen Week 240

  9. Sekundärer Endpunkt

    Change from baseline of non-invasive markers of liver fibrosis: Fibroscan

    Liver stiffness assessed by transient elastography (FibroScan)

    Zeitrahmen 52 Weeks

  10. Sekundärer Endpunkt

    Change from baseline of non-invasive markers of liver fibrosis: Fibroscan

    Liver stiffness assessed by transient elastography (FibroScan)

    Zeitrahmen 96 Weeks, 240 Weeks

  11. Sekundärer Endpunkt

    Change from baseline of markers of liver injury: ALT, AST, GGT

    ALT (U/L), AST (U/L), GGT (U/L)

    Zeitrahmen 52 Weeks, 240 Weeks

  12. Sekundärer Endpunkt

    Change from baseline of markers of liver injury: Uric Acid

    Uric acid (mg/dL)

    Zeitrahmen 52 Weeks, 240 Weeks

  13. Sekundärer Endpunkt

    Change from baseline of lipoproteins: Total cholesterol, TG, Non-HDL-C, HDL-C, and LDL-C

    Total cholesterol (mg/dL), TG (mg/dL), Non-HDL-C (mg/dL), HDL-C (mg/dL), and LDL-C (mg/dL)

    Zeitrahmen 52 Weeks, 240 Weeks

  14. Sekundärer Endpunkt

    Change from baseline of markers of insulin sensitivity and glycemic control: HbA1c

    HbA1c (%)

    Zeitrahmen 52 Weeks, 240 Weeks

  15. Sekundärer Endpunkt

    Change from baseline of markers of insulin sensitivity and glycemic control: Adiponectin

    Adiponectin (mg/L)

    Zeitrahmen 52 Weeks, 240 Weeks

  16. Sekundärer Endpunkt

    Change from baseline of body weight (kg)

    Zeitrahmen 52 Weeks, 240 Weeks

  17. Sekundärer Endpunkt

    To assess the safety and tolerability of EFX through the reporting of extent of exposure (weeks)

    Zeitrahmen 52 Weeks, 240 Weeks

  18. Sekundärer Endpunkt

    To assess the safety and tolerability of EFX through the reporting of adverse events (severity of events)

    Zeitrahmen 52 Weeks, 240 Weeks

  19. Sekundärer Endpunkt

    To assess the safety and tolerability of EFX through the reporting of adverse events (frequency of events)

    Zeitrahmen 52 Weeks, 240 Weeks

  20. Sekundärer Endpunkt

    To assess the safety and tolerability of EFX through the reporting of abnormal clinical laboratory tests, ECGs, ultrasounds, vital sign assessments (number of patients)

    Zeitrahmen 52 Weeks, 240 Weeks

  21. Sekundärer Endpunkt

    To assess the immunogenicity of EFX through the reporting of antidrug antibodies (number of patients)

    Zeitrahmen 52 Weeks, 240 Weeks

Daten

Startdatum1. Dezember 2023 (tatsächlich)
Primärer Abschluss1. Februar 2033 (geschätzt)
Abschluss1. Februar 2033 (geschätzt)
Erstveröffentlichung22. Januar 2024 (tatsächlich)
Zuletzt aktualisiert7. August 2026
Ergebnisse veröffentlichtIm Registereintrag nicht angegeben
Status zuletzt bestätigtAugust 2026

Tatsächlich bedeutet, dass das Ereignis eingetreten ist. Geschätzt bedeutet, dass der Sponsor es erwartet. Die beiden bedeuten Unterschiedliches.

Standorte

319 Studienzentren rekrutieren

Argentina

EinrichtungStadtBundesland oder RegionStatus
Akero Clinical Study SiteBuenos AiresRekrutiert
Akero Clinical Study SiteBuenos AiresRekrutiert
Akero Clinical Study SiteBuenos AiresRekrutiert
Akero Clinical Study SiteBuenos AiresDistrito FederalRekrutiert
Akero Clinical Study SiteCiudad Autónoma de Buenos AiresBuenos AiresRekrutiert
Akero Clinical Study SiteLa PlataBuenos AiresRekrutiert
Akero Clinical Study SiteRamos MejíaBuenos AiresRekrutiert

Australia

EinrichtungStadtBundesland oder RegionStatus
Akero Clinical Study SiteAdelaideSouth AustraliaRekrutiert
Akero Clinical Study SiteBroadmeadowNew South WalesRekrutiert
Akero Clinical Study SiteCaulfield SouthVictoriaRekrutiert
Akero Clinical Study SiteCoffs HarbourNew South WalesRekrutiert
Akero Clinical Study SiteEppingVictoriaRekrutiert
Akero Clinical Study SiteFrankstonVictoriaRekrutiert
Akero Clinical Study SiteHeidelbergVictoriaRekrutiert
Akero Clinical Study SiteKogarahNew South WalesRekrutiert
Akero Clinical Study SiteLiverpoolNew South WalesRekrutiert
Akero Clinical Study SiteMelbourneVictoriaRekrutiert
Akero Clinical Study SiteMurdochWestern AustraliaRekrutiert
Akero Clinical Study SiteNedlandsWestern AustraliaRekrutiert
Akero Clinical Study SitePenrithNew South WalesRekrutiert
Akero Clinical Study SitePerthWestern AustraliaRekrutiert
Akero Clinical Study SiteWestmeadNew South WalesRekrutiert

Canada

EinrichtungStadtBundesland oder RegionStatus
Akero Clinical Study SiteEdmontonAlbertaRekrutiert
Akero Clinical Study SiteHamiltonOntarioRekrutiert
Akero Clinical Study SiteMontrealQuebecRekrutiert
Akero Clinical Study SiteTerrebonneQuebecRekrutiert
Akero Clinical Study SiteTorontoOntarioRekrutiert
Akero Clinical Study SiteVaughanOntarioRekrutiert

France

EinrichtungStadtBundesland oder RegionStatus
Akero Clinical Study SiteAngersMaine-et-LoireRekrutiert
Akero Clinical Study SiteClichyHauts-de-SeineRekrutiert
Akero Clinical Study SiteCréteilVal-De-MarneRekrutiert
Akero Clinical Study SiteLimogesHaute-VienneRekrutiert
Akero Clinical Study SiteLyonAuvergne-Rhône-AlpesRekrutiert
Akero Clinical Study SiteMarseilleProvence-Alpes-Côte d'Azur RegionRekrutiert
Akero Clinical Study SiteMontpellier Cedex 5Provence-Alpes-Côte d'Azur RegionRekrutiert
Akero Clinical Study SiteNiceAlpes-MaritimesRekrutiert
Akero Clinical Study SiteParisÎle-de-France RegionRekrutiert
Akero Clinical Study SiteStrasbourgBas-RhinRekrutiert
Akero Clinical Study SiteToulouseOccitanieRekrutiert
Akero Clinical Study SiteVandœuvre-lès-NancyLorraineRekrutiert
Akero Clinical Study SiteVersaillesYvelines, Île-de-FranceRekrutiert

Germany

EinrichtungStadtBundesland oder RegionStatus
Akero Clinical Study SiteBerlinRekrutiert
Akero Clinical Study SiteBerlinRekrutiert
Akero Clinical Study SiteFrankfurt am MainHesseAbgeschlossen
Akero Clinical Study SiteHomburgSaarlandRekrutiert
Akero Clinical Study SiteLeipzigSaxonyRekrutiert
Akero Clinical Study SiteLeipzigSaxonyAbgeschlossen
Akero Clinical Study SiteLeipzigSaxonyRekrutiert
Akero Clinical Study SiteLübeckSchleswig-HolsteinRekrutiert
Akero Clinical Study SiteMainzRhineland-PalatinateRekrutiert

306 weitere Studienzentren sind im Registereintrag aufgeführt.

Studiendokumente

In diesem Registereintrag sind keine Dokumente verlinkt.

Änderungen im Zeitverlauf

Seit wir diesen Eintrag erstmals eingelesen haben, wurden keine Änderungen erfasst.

Eine Änderung wird jedes Mal erfasst, wenn der Sponsor den Registereintrag aktualisiert. Status, Daten, Teilnahme und Studienzentren erscheinen hier, sobald sie sich ändern.

Register: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT06215716