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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06528314




Registration number
NCT06528314
Ethics application status
Date submitted
28/06/2024
Date registered
30/07/2024

Titles & IDs
Public title
A Study Evaluating Efruxifermin in Subjects with Compensated Cirrhosis Due to NASH/MASH
Scientific title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Efruxifermin in Subjects with Compensated Cirrohosis Due to NASH/MASH
Secondary ID [1] 0 0
AK-US-001-0106
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
NASH - Nonalcoholic Steatohepatitis 0 0
MASH - Metabolic Dysfunction-Associated Steatohepatitis 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

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

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
Time from randomization to first occurrence of disease progression as measured by composite of protocol-specified clinical events
Timepoint [1] 0 0
5 years
Primary outcome [2] 0 0
Cohort 1 only: = 1 stage improvement in fibrosis and no worsening of steatohepatitis
Timepoint [2] 0 0
96 Weeks
Secondary outcome [1] 0 0
Change from baseline of non-invasive markers of liver fibrosis
Timepoint [1] 0 0
96 Weeks
Secondary outcome [2] 0 0
Change from baseline of non-invasive markers of liver fibrosis
Timepoint [2] 0 0
96 Weeks
Secondary outcome [3] 0 0
Change from baseline of non-invasive markers of liver fibrosis
Timepoint [3] 0 0
96 Weeks
Secondary outcome [4] 0 0
Change from baseline of non-invasive markers of liver fibrosis
Timepoint [4] 0 0
96 Weeks
Secondary outcome [5] 0 0
Change from baseline of markers of liver injury
Timepoint [5] 0 0
96 Weeks
Secondary outcome [6] 0 0
Change from baseline of lipoproteins
Timepoint [6] 0 0
96 Weeks
Secondary outcome [7] 0 0
Change from baseline of markers of insulin sensitivity and glycemic control
Timepoint [7] 0 0
96 Weeks
Secondary outcome [8] 0 0
Change from baseline of markers of insulin sensitivity and glycemic control
Timepoint [8] 0 0
96 Weeks
Secondary outcome [9] 0 0
Change from baseline of markers of insulin sensitivity and glycemic control
Timepoint [9] 0 0
96 Weeks
Secondary outcome [10] 0 0
Change from baseline of markers of insulin sensitivity and glycemic control
Timepoint [10] 0 0
96 Weeks
Secondary outcome [11] 0 0
Change from baseline of markers of insulin sensitivity and glycemic control
Timepoint [11] 0 0
96 Weeks
Secondary outcome [12] 0 0
Change from baseline of body weight (kg)
Timepoint [12] 0 0
96 Weeks
Secondary outcome [13] 0 0
To assess the safety and tolerability of EFX through the reporting of extent of exposure (weeks)
Timepoint [13] 0 0
96 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
96 Weeks
Secondary outcome [15] 0 0
To assess the safety and tolerability of EFX through the reporting of adverse events (severity of events)
Timepoint [15] 0 0
96 Weeks
Secondary outcome [16] 0 0
Number of participants with abnormal laboratory tests results, abnormal ECGs, abnormal ultrasounds, abnormal vital sign assessments
Timepoint [16] 0 0
96 Weeks
Secondary outcome [17] 0 0
Cohort 1 only: = 1 stage improvement in fibrosis and no worsening of steatohepatitis
Timepoint [17] 0 0
5 Years
Secondary outcome [18] 0 0
Cohort 1 only: = 1 stage improvement in fibrosis
Timepoint [18] 0 0
96 Weeks, 5 Years
Secondary outcome [19] 0 0
Cohort 1 only: Resolution of NASH/MASH
Timepoint [19] 0 0
96 Weeks, 5 Years
Secondary outcome [20] 0 0
Cohort 1 only: Resolution of NASH/MASH and a = 1 stage improvement in fibrosis
Timepoint [20] 0 0
96 Weeks, 5 Years

Eligibility
Key inclusion criteria
* Cohort 1: Biopsy proven compensated cirrhosis (fibrosis stage 4) due to NASH/MASH
* Cohort 2: Biopsy proven or non-invasively diagnosed compensated cirrhosis (fibrosis stage 4) due to NASH/MASH
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
* Type 1 diabetes or unstable Type 2 diabetes
* Any current or prior history of decompensated liver disease

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
4/09/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/10/2029
Actual
Sample size
Target
1150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Akero Clinical Study Site - Westmead
Recruitment hospital [2] 0 0
Akero Clinical Study Site - Adelaide
Recruitment hospital [3] 0 0
Akero Clinical Study Site - Box Hill
Recruitment hospital [4] 0 0
Akero Clinical Study Site - Clayton
Recruitment hospital [5] 0 0
Akero Clinical Study Site - Epping
Recruitment hospital [6] 0 0
Akero Clinical Study Site - Melbourne
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
3128 - Box Hill
Recruitment postcode(s) [4] 0 0
3168 - Clayton
Recruitment postcode(s) [5] 0 0
3076 - Epping
Recruitment postcode(s) [6] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Kansas
Country [10] 0 0
United States of America
State/province [10] 0 0
Louisiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Maryland
Country [12] 0 0
United States of America
State/province [12] 0 0
Massachusetts
Country [13] 0 0
United States of America
State/province [13] 0 0
Michigan
Country [14] 0 0
United States of America
State/province [14] 0 0
Missouri
Country [15] 0 0
United States of America
State/province [15] 0 0
Nevada
Country [16] 0 0
United States of America
State/province [16] 0 0
New Jersey
Country [17] 0 0
United States of America
State/province [17] 0 0
New York
Country [18] 0 0
United States of America
State/province [18] 0 0
North Carolina
Country [19] 0 0
United States of America
State/province [19] 0 0
Ohio
Country [20] 0 0
United States of America
State/province [20] 0 0
Pennsylvania
Country [21] 0 0
United States of America
State/province [21] 0 0
South Carolina
Country [22] 0 0
United States of America
State/province [22] 0 0
Tennessee
Country [23] 0 0
United States of America
State/province [23] 0 0
Texas
Country [24] 0 0
United States of America
State/province [24] 0 0
Virginia
Country [25] 0 0
Canada
State/province [25] 0 0
Alberta
Country [26] 0 0
Canada
State/province [26] 0 0
Ontario
Country [27] 0 0
France
State/province [27] 0 0
Hauts-de-Seine
Country [28] 0 0
France
State/province [28] 0 0
Ile-de-France
Country [29] 0 0
India
State/province [29] 0 0
Gujarat
Country [30] 0 0
India
State/province [30] 0 0
Maharashtra
Country [31] 0 0
India
State/province [31] 0 0
Rajasthan
Country [32] 0 0
India
State/province [32] 0 0
Telangana
Country [33] 0 0
India
State/province [33] 0 0
Uttar Pradesh
Country [34] 0 0
India
State/province [34] 0 0
West Bengal
Country [35] 0 0
Puerto Rico
State/province [35] 0 0
Manatí
Country [36] 0 0
Puerto Rico
State/province [36] 0 0
San Juan
Country [37] 0 0
Spain
State/province [37] 0 0
Cantabria

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.


Results not provided in https://clinicaltrials.gov/study/NCT06528314