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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

قيد التجنيديقبل مشاركين الآن، وفقاً لسجل السجل.
التواصل مع هذه الدراسة

باختصار

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…

المرحلة 3مطلوب 1,650 مشاركاً356 موقعاً18 دولة

الفئات

أمراض الجهاز الهضمي والكبد73%الغدد الصمّاء والأيض27%

مسجَّلة في سجل واحد

يمكن أن تُسجَّل دراسة واحدة في عدة سجلات. نعرضها مرة واحدة ونربط بكل سجل نحتفظ به.

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هل أنت مهتم بهذه الدراسة؟

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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.

ملخص

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.

الحالات

  • NASH With Fibrosis
  • MASH With Fibrosis

الأهلية

الجنسالجميع
الأعمار18 Years – 80 Years
المتطوعون الأصحّاءلا

الأهلية كما كُتبت في السجل

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.

الأهلية في عبارات بسيطة

لم تُقسَّم معايير هذا السجل إلى عبارات منفصلة بعد. نص السجل أعلاه كامل وهو النسخة المُعتمَدة.

تصميم الدراسة

نوع الدراسةتدخّلية
المرحلةالمرحلة 3
التخصيصمعشّاة
نموذج التدخّلPARALLEL
الغرض الأساسيTREATMENT
التعميةQUADRUPLE (4)
التجنيدمطلوب 1,650 مشاركاً

الجهة الراعية والمتعاونون

  • Akero Therapeutics, Inc الجهة الراعية

الأذرع والتدخلات

  • EFX 28 mgEXPERIMENTAL
  • EFX 50 mgEXPERIMENTAL
  • PlaceboPLACEBO_COMPARATOR

التدخلات

  • دواء Efruxifermin

    Administered by subcutaneous injection

  • دواء Placebo

    Administered by subcutaneous injection

مقاييس النتائج

  1. مقياس النتيجة الأولي

    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)

    الإطار الزمني 52 Weeks

  2. مقياس النتيجة الأولي

    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.

    الإطار الزمني 240 Weeks

  3. مقياس النتيجة الثانوي

    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)

    الإطار الزمني 52 Weeks

  4. مقياس النتيجة الثانوي

    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)

    الإطار الزمني 52 Weeks

  5. مقياس النتيجة الثانوي

    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)

    الإطار الزمني 52 Weeks

  6. مقياس النتيجة الثانوي

    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.

    الإطار الزمني 52 Weeks

  7. مقياس النتيجة الثانوي

    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.

    الإطار الزمني 96 Weeks, 240 Weeks

  8. مقياس النتيجة الثانوي

    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.

    الإطار الزمني Week 240

  9. مقياس النتيجة الثانوي

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

    Liver stiffness assessed by transient elastography (FibroScan)

    الإطار الزمني 52 Weeks

  10. مقياس النتيجة الثانوي

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

    Liver stiffness assessed by transient elastography (FibroScan)

    الإطار الزمني 96 Weeks, 240 Weeks

  11. مقياس النتيجة الثانوي

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

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

    الإطار الزمني 52 Weeks, 240 Weeks

  12. مقياس النتيجة الثانوي

    Change from baseline of markers of liver injury: Uric Acid

    Uric acid (mg/dL)

    الإطار الزمني 52 Weeks, 240 Weeks

  13. مقياس النتيجة الثانوي

    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)

    الإطار الزمني 52 Weeks, 240 Weeks

  14. مقياس النتيجة الثانوي

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

    HbA1c (%)

    الإطار الزمني 52 Weeks, 240 Weeks

  15. مقياس النتيجة الثانوي

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

    Adiponectin (mg/L)

    الإطار الزمني 52 Weeks, 240 Weeks

  16. مقياس النتيجة الثانوي

    Change from baseline of body weight (kg)

    الإطار الزمني 52 Weeks, 240 Weeks

  17. مقياس النتيجة الثانوي

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

    الإطار الزمني 52 Weeks, 240 Weeks

  18. مقياس النتيجة الثانوي

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

    الإطار الزمني 52 Weeks, 240 Weeks

  19. مقياس النتيجة الثانوي

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

    الإطار الزمني 52 Weeks, 240 Weeks

  20. مقياس النتيجة الثانوي

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

    الإطار الزمني 52 Weeks, 240 Weeks

  21. مقياس النتيجة الثانوي

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

    الإطار الزمني 52 Weeks, 240 Weeks

التواريخ

تاريخ البدء1 ديسمبر 2023 (فعلي)
الإتمام الأولي1 فبراير 2033 (تقديري)
الإتمام1 فبراير 2033 (تقديري)
أول نشر22 يناير 2024 (فعلي)
آخر تحديث7 أغسطس 2026
النتائج منشورةغير مذكور في سجل السجل
آخر تأكيد للحالةأغسطس 2026

فعلي يعني أن الحدث وقع. تقديري يعني أن الجهة الراعية تتوقعه. للكلمتين معنيان مختلفان.

المواقع

319 موقعاً قيد التجنيد

Argentina

المنشأةالمدينةالولاية أو المنطقةالحالة
Akero Clinical Study SiteBuenos Airesقيد التجنيد
Akero Clinical Study SiteBuenos Airesقيد التجنيد
Akero Clinical Study SiteBuenos Airesقيد التجنيد
Akero Clinical Study SiteBuenos AiresDistrito Federalقيد التجنيد
Akero Clinical Study SiteCiudad Autónoma de Buenos AiresBuenos Airesقيد التجنيد
Akero Clinical Study SiteLa PlataBuenos Airesقيد التجنيد
Akero Clinical Study SiteRamos MejíaBuenos Airesقيد التجنيد

Australia

المنشأةالمدينةالولاية أو المنطقةالحالة
Akero Clinical Study SiteAdelaideSouth Australiaقيد التجنيد
Akero Clinical Study SiteBroadmeadowNew South Walesقيد التجنيد
Akero Clinical Study SiteCaulfield SouthVictoriaقيد التجنيد
Akero Clinical Study SiteCoffs HarbourNew South Walesقيد التجنيد
Akero Clinical Study SiteEppingVictoriaقيد التجنيد
Akero Clinical Study SiteFrankstonVictoriaقيد التجنيد
Akero Clinical Study SiteHeidelbergVictoriaقيد التجنيد
Akero Clinical Study SiteKogarahNew South Walesقيد التجنيد
Akero Clinical Study SiteLiverpoolNew South Walesقيد التجنيد
Akero Clinical Study SiteMelbourneVictoriaقيد التجنيد
Akero Clinical Study SiteMurdochWestern Australiaقيد التجنيد
Akero Clinical Study SiteNedlandsWestern Australiaقيد التجنيد
Akero Clinical Study SitePenrithNew South Walesقيد التجنيد
Akero Clinical Study SitePerthWestern Australiaقيد التجنيد
Akero Clinical Study SiteWestmeadNew South Walesقيد التجنيد

Canada

المنشأةالمدينةالولاية أو المنطقةالحالة
Akero Clinical Study SiteEdmontonAlbertaقيد التجنيد
Akero Clinical Study SiteHamiltonOntarioقيد التجنيد
Akero Clinical Study SiteMontrealQuebecقيد التجنيد
Akero Clinical Study SiteTerrebonneQuebecقيد التجنيد
Akero Clinical Study SiteTorontoOntarioقيد التجنيد
Akero Clinical Study SiteVaughanOntarioقيد التجنيد

France

المنشأةالمدينةالولاية أو المنطقةالحالة
Akero Clinical Study SiteAngersMaine-et-Loireقيد التجنيد
Akero Clinical Study SiteClichyHauts-de-Seineقيد التجنيد
Akero Clinical Study SiteCréteilVal-De-Marneقيد التجنيد
Akero Clinical Study SiteLimogesHaute-Vienneقيد التجنيد
Akero Clinical Study SiteLyonAuvergne-Rhône-Alpesقيد التجنيد
Akero Clinical Study SiteMarseilleProvence-Alpes-Côte d'Azur Regionقيد التجنيد
Akero Clinical Study SiteMontpellier Cedex 5Provence-Alpes-Côte d'Azur Regionقيد التجنيد
Akero Clinical Study SiteNiceAlpes-Maritimesقيد التجنيد
Akero Clinical Study SiteParisÎle-de-France Regionقيد التجنيد
Akero Clinical Study SiteStrasbourgBas-Rhinقيد التجنيد
Akero Clinical Study SiteToulouseOccitanieقيد التجنيد
Akero Clinical Study SiteVandœuvre-lès-NancyLorraineقيد التجنيد
Akero Clinical Study SiteVersaillesYvelines, Île-de-Franceقيد التجنيد

Germany

المنشأةالمدينةالولاية أو المنطقةالحالة
Akero Clinical Study SiteBerlinقيد التجنيد
Akero Clinical Study SiteBerlinقيد التجنيد
Akero Clinical Study SiteFrankfurt am MainHesseمكتمل
Akero Clinical Study SiteHomburgSaarlandقيد التجنيد
Akero Clinical Study SiteLeipzigSaxonyقيد التجنيد
Akero Clinical Study SiteLeipzigSaxonyمكتمل
Akero Clinical Study SiteLeipzigSaxonyقيد التجنيد
Akero Clinical Study SiteLübeckSchleswig-Holsteinقيد التجنيد
Akero Clinical Study SiteMainzRhineland-Palatinateقيد التجنيد

تُدرَج 306 مواقع إضافية في سجل السجل.

مستندات الدراسة

لا تُرتبط أي مستندات في سجل السجل هذا.

التغيّرات عبر الزمن

لم تُسجَّل أي تغييرات منذ أن أدرجنا هذا السجل لأول مرة.

يُسجَّل تغيير في كل مرة تحدّث فيها الجهة الراعية سجل السجل. تظهر هنا الحالة والتواريخ والتجنيد والمواقع كلما تغيّرت.

السجل: ClinicalTrials.gov · NCT########

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