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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
Cohort 1 Only: Resolution of NASH/MASH and a = 1 stage improvement in fibrosis
Timepoint [1] 0 0
52 Weeks
Primary outcome [2] 0 0
Event-free survival
Timepoint [2] 0 0
240 Weeks
Secondary outcome [1] 0 0
Cohort 1 Only: Resolution of NASH/MASH and no worsening of fibrosis
Timepoint [1] 0 0
52 Weeks
Secondary outcome [2] 0 0
Cohort 1 Only: = 1 stage improvement in fibrosis and no worsening of steatohepatitis
Timepoint [2] 0 0
52 Weeks
Secondary outcome [3] 0 0
Change from baseline of non-invasive markers of liver fibrosis
Timepoint [3] 0 0
52 Weeks, 240 Weeks
Secondary outcome [4] 0 0
Change from baseline of non-invasive markers of liver fibrosis
Timepoint [4] 0 0
52 Weeks, 240 Weeks
Secondary outcome [5] 0 0
Change from baseline of non-invasive markers of liver fibrosis
Timepoint [5] 0 0
52 Weeks, 240 Weeks
Secondary outcome [6] 0 0
Change from baseline of markers of liver injury
Timepoint [6] 0 0
52 Weeks, 240 Weeks
Secondary outcome [7] 0 0
Change from baseline of markers of liver injury
Timepoint [7] 0 0
52 Weeks, 240 Weeks
Secondary outcome [8] 0 0
Change from baseline of lipoproteins
Timepoint [8] 0 0
52 Weeks, 240 Weeks
Secondary outcome [9] 0 0
Change from baseline of markers of insulin sensitivity and glycemic control
Timepoint [9] 0 0
52 Weeks, 240 Weeks
Secondary outcome [10] 0 0
Change from baseline of markers of insulin sensitivity and glycemic control
Timepoint [10] 0 0
52 Weeks, 240 Weeks
Secondary outcome [11] 0 0
Change from baseline of body weight (kg)
Timepoint [11] 0 0
52 Weeks, 240 Weeks
Secondary outcome [12] 0 0
To assess the safety and tolerability of EFX through the reporting of extent of exposure (weeks)
Timepoint [12] 0 0
52 Weeks, 240 Weeks
Secondary outcome [13] 0 0
To assess the safety and tolerability of EFX through the reporting of adverse events (severity of events)
Timepoint [13] 0 0
52 Weeks, 240 Weeks
Secondary outcome [14] 0 0
To assess the safety and tolerability of EFX through the reporting of adverse events (frequency of events)
Timepoint [14] 0 0
52 Weeks, 240 Weeks
Secondary outcome [15] 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 [15] 0 0
52 Weeks, 240 Weeks
Secondary outcome [16] 0 0
To assess the immunogenicity of EFX through the reporting of antidrug antibodies (number of patients)
Timepoint [16] 0 0
52 Weeks, 240 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.
* 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).
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 (fibrosis stage 4).
* 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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
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 - Epping
Recruitment hospital [6] 0 0
Akero Clinical Study Site - Heidelberg
Recruitment hospital [7] 0 0
Akero Clinical Study Site - Melbourne
Recruitment hospital [8] 0 0
Akero Clinical Study Site - Murdoch
Recruitment hospital [9] 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
3076 - Epping
Recruitment postcode(s) [6] 0 0
3084 - Heidelberg
Recruitment postcode(s) [7] 0 0
3004 - Melbourne
Recruitment postcode(s) [8] 0 0
6150 - Murdoch
Recruitment postcode(s) [9] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
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Alabama
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Arizona
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Arkansas
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Colorado
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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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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 York
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Switzerland
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Taichung
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Taipei
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Taoyuan
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Ankara
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Izmir
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Bursa
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Rize
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United Kingdom
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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
AkeroSynchrony@akerotx.com
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.