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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06215716




Registration number
NCT06215716
Ethics application status
Date submitted
6/12/2023
Date registered
22/01/2024

Titles & IDs
Public title
A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis
Scientific title
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
Secondary ID [1] 0 0
AK-US-001-0105
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
NASH With Fibrosis 0 0
MASH With Fibrosis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Metabolic and Endocrine 0 0 0 0
Metabolic disorders
Diet and Nutrition 0 0 0 0
Obesity
Inflammatory and Immune System 0 0 0 0
Connective tissue diseases
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Efruxifermin
Treatment: Drugs - Placebo

Experimental: EFX 28 mg -

Experimental: EFX 50 mg -

Placebo comparator: Placebo -


Treatment: Drugs: Efruxifermin
Administered by subcutaneous injection

Treatment: Drugs: Placebo
Administered by subcutaneous injection
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Resolution of NASH/MASH and a = 1 stage improvement in fibrosis
Timepoint [1] 0 0
52 Weeks
Secondary outcome [1] 0 0
Resolution of NASH/MASH and no worsening of fibrosis
Timepoint [1] 0 0
52 Weeks
Secondary outcome [2] 0 0
Change from baseline in liver fibrosis and no worsening of steatohepatitis
Timepoint [2] 0 0
52 Weeks
Secondary outcome [3] 0 0
Resolution of NASH/MASH and a = 1 stage improvement in fibrosis
Timepoint [3] 0 0
96 Weeks
Secondary outcome [4] 0 0
Resolution of NASH/MASH and no worsening of fibrosis
Timepoint [4] 0 0
96 Weeks
Secondary outcome [5] 0 0
Change from baseline in liver fibrosis and no worsening of steatohepatitis
Timepoint [5] 0 0
96 Weeks
Secondary outcome [6] 0 0
Change from baseline of non-invasive markers of liver fibrosis
Timepoint [6] 0 0
52 Weeks, 96 Weeks
Secondary outcome [7] 0 0
Change from baseline of non-invasive markers of liver fibrosis
Timepoint [7] 0 0
52 Weeks, 96 Weeks
Secondary outcome [8] 0 0
Change from baseline of non-invasive markers of liver fibrosis
Timepoint [8] 0 0
52 Weeks, 96 Weeks
Secondary outcome [9] 0 0
Change from baseline of non-invasive markers of liver fibrosis
Timepoint [9] 0 0
52 Weeks, 96 Weeks
Secondary outcome [10] 0 0
Change from baseline of markers of liver injury
Timepoint [10] 0 0
52 Weeks, 96 Weeks
Secondary outcome [11] 0 0
Change from baseline of markers of liver injury
Timepoint [11] 0 0
52 Weeks, 96 Weeks
Secondary outcome [12] 0 0
Change from baseline of lipoproteins
Timepoint [12] 0 0
52 Weeks, 96 Weeks
Secondary outcome [13] 0 0
Change from baseline of markers of insulin sensitivity and glycemic control
Timepoint [13] 0 0
52 Weeks, 96 Weeks
Secondary outcome [14] 0 0
Change from baseline of markers of insulin sensitivity and glycemic control
Timepoint [14] 0 0
52 Weeks, 96 Weeks
Secondary outcome [15] 0 0
Change from baseline of body weight (kg)
Timepoint [15] 0 0
52 Weeks, 96 Weeks
Secondary outcome [16] 0 0
To assess the safety and tolerability of EFX through the reporting of extent of exposure (weeks)
Timepoint [16] 0 0
52 Weeks, 96 Weeks
Secondary outcome [17] 0 0
To assess the safety and tolerability of EFX through the reporting of adverse events (severity of events)
Timepoint [17] 0 0
52 Weeks, 96 Weeks
Secondary outcome [18] 0 0
To assess the safety and tolerability of EFX through the reporting of adverse events (frequency of events)
Timepoint [18] 0 0
52 Weeks, 96 Weeks
Secondary outcome [19] 0 0
To assess the safety and tolerability of EFX through the reporting of abnormal clinical laboratory tests, ECGs, ultrasounds, vital sign assessments (number of patients)
Timepoint [19] 0 0
52 Weeks, 96 Weeks

Eligibility
Key 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
* FibroScan® measurement > 7.5 kPa
* ELF score = 7.7
* Biopsy-proven NASH. 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).
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 (stage 4 fibrosis)
* Type 1 or uncontrolled Type 2 diabetes

Other inclusion and exclusion criteria may apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2027
Actual
Sample size
Target
1000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
Akero Clinical Study Site - Broadmeadow
Recruitment hospital [2] 0 0
Akero Clinical Study Site - Westmead
Recruitment hospital [3] 0 0
Akero Clinical Study Site - Adelaide
Recruitment hospital [4] 0 0
Akero Clinical Study Site - Caulfield South
Recruitment hospital [5] 0 0
Akero Clinical Study Site - Heidelberg
Recruitment hospital [6] 0 0
Akero Clinical Study Site - Melbourne
Recruitment hospital [7] 0 0
Akero Clinical Study Site - Murdoch
Recruitment hospital [8] 0 0
Akero Clinical Study Site - Perth
Recruitment postcode(s) [1] 0 0
2292 - Broadmeadow
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
3162 - Caulfield South
Recruitment postcode(s) [5] 0 0
3084 - Heidelberg
Recruitment postcode(s) [6] 0 0
3004 - Melbourne
Recruitment postcode(s) [7] 0 0
6150 - Murdoch
Recruitment postcode(s) [8] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
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Arizona
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Arkansas
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California
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Colorado
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Florida
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Georgia
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Indiana
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Iowa
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Kansas
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Louisiana
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Maryland
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Massachusetts
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Michigan
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Missouri
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Nevada
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New Jersey
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New Mexico
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New York
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North Carolina
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Ohio
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Oregon
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Pennsylvania
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Utah
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Virginia
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Washington
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Argentina
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Buenos Aires
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Canada
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Alberta
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Canada
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Ontario
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Canada
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Quebec
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France
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Alpes-Maritimes
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Ile-de-France
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Lorraine
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France
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Maine-et-Loire
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France
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Occitanie
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France
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Provence Alpes Cote d'Azur
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France
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Provence-Alpes-Côte d'Azur
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France
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Rhone-Alpes
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Germany
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Bayern
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Germany
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Hessen
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Germany
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Rheinland-Pfalz
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Germany
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Sachsen
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Germany
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Gujarat
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Kerala
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Maharashtra
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Rajasthan
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India
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Tamil Nadu
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Telangana
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Uttar Pradesh
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West Bengal
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Israel
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Haifa District
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Northern District
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Foggia
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Bologna
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Messina
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Napoli
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Novara
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Daegu Gwang'yeogsi [Taegu-Kwangyokshi]
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Korea, Republic of
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Gyeonggi-Do
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Korea, Republic of
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Dolnoslaskie
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Malopolskie
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Mazowieckie
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Pomorskie
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Slaskie
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Wielkopolskie
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Lódzkie
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Puerto Rico
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Manati
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Puerto Rico
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San Juan
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Spain
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Barcelona
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Spain
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Cantabria
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Spain
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Madrid
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Spain
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València
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Spain
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Sevilla
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Switzerland
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Solothurn
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Switzerland
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Bern
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Switzerland
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Sankt Gallen
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Taiwan
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Taichung
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United Kingdom
State/province [94] 0 0
England

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Akero Therapeutics, Inc
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Akero Study Director
Address 0 0
Country 0 0
Phone 0 0
650-487-6488
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06215716