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

מגייסמקבל משתתפים כעת, לפי רשומת המרשם.

יצירת קשר עם המחקר

בקצרה

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…

שלב 3דרושים 1,650 משתתפים356 אתרים18 מדינות

קטגוריות

גסטרואנטרולוגיה והפטולוגיה73%אנדוקריני ומטבולי27%

רשום במרשם אחד

ClinicalTrials.govNCT06215716פתיחת רשומה זו ב־ClinicalTrials.govסונכרן החודש שעבר

מחקר יחיד יכול להיות רשום בכמה מרשמים. אנו מציגים אותו פעם אחת ומקשרים לכל רשומה שברשותנו.

מידע הניסוי מוצג כפי שפורסם על ידי המרשם, בשפת המקור שלו.

מתעניינים במחקר הזה?

התחברות או צרו חשבון כדי לרשום את התעניינותכם ולעקוב אחר המחקר הזה.

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.

Not stated: Registered after enrolment began (about 52 days after the recorded start)First posted 2024-01-22; recorded start 2023-12-01
Present: Has a defined primary outcomeA primary outcome measure is listed in the record
Present: The primary outcome states a time frameThe primary outcome measure records a time frame
Present: Participants are randomly assignedAllocation is recorded as randomised
Present: Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
Present: Uses blinding (masking)A masking level is recorded in the record
Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
Not stated: 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.
Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
Present: Sponsor has 4 other studies in this databaseCounted from the lead sponsor named in the record (Akero Therapeutics, Inc)
Not stated: 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.

תקציר

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.

מצבים רפואיים

NASH With Fibrosis
MASH With Fibrosis

זכאות

זכאות
מין	הכול
גילאים	18 Years – 80 Years
מתנדבים בריאים	לא

זכאות כפי שנכתבה במרשם

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.

זכאות במשפטים פשוטים

הקריטריונים של רשומה זו טרם פורקו למשפטים נפרדים. טקסט המרשם שלמעלה שלם והוא הגרסה המחייבת.

תכנון המחקר

תכנון המחקר
סוג המחקר	התערבותי
שלב	שלב 3
הקצאה	אקראי
מודל ההתערבות	PARALLEL
מטרה ראשית	TREATMENT
הסתרה	QUADRUPLE (4)
גיוס	דרושים 1,650 משתתפים

נותן חסות ושותפים

Akero Therapeutics, Inc נותן חסות

זרועות והתערבויות

EFX 28 mgEXPERIMENTAL
EFX 50 mgEXPERIMENTAL
PlaceboPLACEBO_COMPARATOR

התערבויות

תרופה Efruxifermin
Administered by subcutaneous injection
תרופה Placebo
Administered by subcutaneous injection

מדדי תוצאה

מדד תוצאה ראשוני
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)
מסגרת זמן 52 Weeks
מדד תוצאה ראשוני
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.
מסגרת זמן 240 Weeks
מדד תוצאה משני
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)
מסגרת זמן 52 Weeks
מדד תוצאה משני
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)
מסגרת זמן 52 Weeks
מדד תוצאה משני
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)
מסגרת זמן 52 Weeks
מדד תוצאה משני
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.
מסגרת זמן 52 Weeks
מדד תוצאה משני
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.
מסגרת זמן 96 Weeks, 240 Weeks
מדד תוצאה משני
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.
מסגרת זמן Week 240
מדד תוצאה משני
Change from baseline of non-invasive markers of liver fibrosis: Fibroscan
Liver stiffness assessed by transient elastography (FibroScan)
מסגרת זמן 52 Weeks
מדד תוצאה משני
Change from baseline of non-invasive markers of liver fibrosis: Fibroscan
Liver stiffness assessed by transient elastography (FibroScan)
מסגרת זמן 96 Weeks, 240 Weeks
מדד תוצאה משני
Change from baseline of markers of liver injury: ALT, AST, GGT
ALT (U/L), AST (U/L), GGT (U/L)
מסגרת זמן 52 Weeks, 240 Weeks
מדד תוצאה משני
Change from baseline of markers of liver injury: Uric Acid
Uric acid (mg/dL)
מסגרת זמן 52 Weeks, 240 Weeks
מדד תוצאה משני
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)
מסגרת זמן 52 Weeks, 240 Weeks
מדד תוצאה משני
Change from baseline of markers of insulin sensitivity and glycemic control: HbA1c
HbA1c (%)
מסגרת זמן 52 Weeks, 240 Weeks
מדד תוצאה משני
Change from baseline of markers of insulin sensitivity and glycemic control: Adiponectin
Adiponectin (mg/L)
מסגרת זמן 52 Weeks, 240 Weeks
מדד תוצאה משני
Change from baseline of body weight (kg)
מסגרת זמן 52 Weeks, 240 Weeks
מדד תוצאה משני
To assess the safety and tolerability of EFX through the reporting of extent of exposure (weeks)
מסגרת זמן 52 Weeks, 240 Weeks
מדד תוצאה משני
To assess the safety and tolerability of EFX through the reporting of adverse events (severity of events)
מסגרת זמן 52 Weeks, 240 Weeks
מדד תוצאה משני
To assess the safety and tolerability of EFX through the reporting of adverse events (frequency of events)
מסגרת זמן 52 Weeks, 240 Weeks
מדד תוצאה משני
To assess the safety and tolerability of EFX through the reporting of abnormal clinical laboratory tests, ECGs, ultrasounds, vital sign assessments (number of patients)
מסגרת זמן 52 Weeks, 240 Weeks
מדד תוצאה משני
To assess the immunogenicity of EFX through the reporting of antidrug antibodies (number of patients)
מסגרת זמן 52 Weeks, 240 Weeks

תאריכים

תאריכים
תאריך התחלה	1 בדצמבר 2023 (בפועל)
סיום ראשוני	1 בפברואר 2033 (משוער)
סיום	1 בפברואר 2033 (משוער)
פורסם לראשונה	22 בינואר 2024 (בפועל)
עודכן לאחרונה	7 באוגוסט 2026
התוצאות פורסמו	לא צוין ברשומת המרשם
המצב אומת לאחרונה	אוגוסט 2026

בפועל פירושו שהאירוע התרחש. משוער פירושו שנותן החסות צופה אותו. שתי המשמעויות שונות זו מזו.

מיקומים

319 אתרים מגייסים

Argentina

Argentina
מתקן	עיר	מדינה או אזור	מצב
Akero Clinical Study Site	Buenos Aires		מגייס
Akero Clinical Study Site	Buenos Aires		מגייס
Akero Clinical Study Site	Buenos Aires		מגייס
Akero Clinical Study Site	Buenos Aires	Distrito Federal	מגייס
Akero Clinical Study Site	Ciudad Autónoma de Buenos Aires	Buenos Aires	מגייס
Akero Clinical Study Site	La Plata	Buenos Aires	מגייס
Akero Clinical Study Site	Ramos Mejía	Buenos Aires	מגייס

Australia

Australia
מתקן	עיר	מדינה או אזור	מצב
Akero Clinical Study Site	Adelaide	South Australia	מגייס
Akero Clinical Study Site	Broadmeadow	New South Wales	מגייס
Akero Clinical Study Site	Caulfield South	Victoria	מגייס
Akero Clinical Study Site	Coffs Harbour	New South Wales	מגייס
Akero Clinical Study Site	Epping	Victoria	מגייס
Akero Clinical Study Site	Frankston	Victoria	מגייס
Akero Clinical Study Site	Heidelberg	Victoria	מגייס
Akero Clinical Study Site	Kogarah	New South Wales	מגייס
Akero Clinical Study Site	Liverpool	New South Wales	מגייס
Akero Clinical Study Site	Melbourne	Victoria	מגייס
Akero Clinical Study Site	Murdoch	Western Australia	מגייס
Akero Clinical Study Site	Nedlands	Western Australia	מגייס
Akero Clinical Study Site	Penrith	New South Wales	מגייס
Akero Clinical Study Site	Perth	Western Australia	מגייס
Akero Clinical Study Site	Westmead	New South Wales	מגייס

Canada

Canada
מתקן	עיר	מדינה או אזור	מצב
Akero Clinical Study Site	Edmonton	Alberta	מגייס
Akero Clinical Study Site	Hamilton	Ontario	מגייס
Akero Clinical Study Site	Montreal	Quebec	מגייס
Akero Clinical Study Site	Terrebonne	Quebec	מגייס
Akero Clinical Study Site	Toronto	Ontario	מגייס
Akero Clinical Study Site	Vaughan	Ontario	מגייס

France

France
מתקן	עיר	מדינה או אזור	מצב
Akero Clinical Study Site	Angers	Maine-et-Loire	מגייס
Akero Clinical Study Site	Clichy	Hauts-de-Seine	מגייס
Akero Clinical Study Site	Créteil	Val-De-Marne	מגייס
Akero Clinical Study Site	Limoges	Haute-Vienne	מגייס
Akero Clinical Study Site	Lyon	Auvergne-Rhône-Alpes	מגייס
Akero Clinical Study Site	Marseille	Provence-Alpes-Côte d'Azur Region	מגייס
Akero Clinical Study Site	Montpellier Cedex 5	Provence-Alpes-Côte d'Azur Region	מגייס
Akero Clinical Study Site	Nice	Alpes-Maritimes	מגייס
Akero Clinical Study Site	Paris	Île-de-France Region	מגייס
Akero Clinical Study Site	Strasbourg	Bas-Rhin	מגייס
Akero Clinical Study Site	Toulouse	Occitanie	מגייס
Akero Clinical Study Site	Vandœuvre-lès-Nancy	Lorraine	מגייס
Akero Clinical Study Site	Versailles	Yvelines, Île-de-France	מגייס

Germany

Germany
מתקן	עיר	מדינה או אזור	מצב
Akero Clinical Study Site	Berlin		מגייס
Akero Clinical Study Site	Berlin		מגייס
Akero Clinical Study Site	Frankfurt am Main	Hesse	הושלם
Akero Clinical Study Site	Homburg	Saarland	מגייס
Akero Clinical Study Site	Leipzig	Saxony	מגייס
Akero Clinical Study Site	Leipzig	Saxony	הושלם
Akero Clinical Study Site	Leipzig	Saxony	מגייס
Akero Clinical Study Site	Lübeck	Schleswig-Holstein	מגייס
Akero Clinical Study Site	Mainz	Rhineland-Palatinate	מגייס

306 אתרים נוספים מצוינים ברשומת המרשם.

מסמכי המחקר

לא צורפו מסמכים ברשומת מרשם זו.

שינויים לאורך זמן

לא נרשמו שינויים מאז שקלטנו רשומה זו לראשונה.

שינוי נרשם בכל פעם שנותן החסות מעדכן את רשומת המרשם. מצב, תאריכים, גיוס ואתרים מופיעים כאן ככל שהם משתנים.

מרשם: ClinicalTrials.gov · NCT########

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