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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06161571




Registration number
NCT06161571
Ethics application status
Date submitted
22/11/2023
Date registered
8/12/2023
Date last updated
7/11/2024

Titles & IDs
Public title
A Study Evaluating Efruxifermin in Subjects with Non-invasively Diagnosed Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Nonalcoholic Fatty Liver Disease (NAFLD)/Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Scientific title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Efruxifermin in Subjects with Non-invasively Diagnosed Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Nonalcoholic Fatty Liver Disease (NAFLD)/Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Secondary ID [1] 0 0
AK-US-001-0107
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
NASH/MASH 0 0
NAFLD/MASLD 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
Cancer 0 0 0 0
Liver
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 -

Experimental: EFX 50 mg (Open-Label Rollover) -


Treatment: Drugs: Efruxifermin
Administered by subcutaneous (SC) injection

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

Outcomes
Primary outcome [1] 0 0
Extent of exposure
Timepoint [1] 0 0
52 Weeks
Primary outcome [2] 0 0
Number of participants with adverse events
Timepoint [2] 0 0
52 Weeks
Primary outcome [3] 0 0
Number of participants with adverse events by severity
Timepoint [3] 0 0
52 Weeks
Primary outcome [4] 0 0
Number of participants with clinically significant changes in clinical assessments
Timepoint [4] 0 0
52 Weeks
Secondary outcome [1] 0 0
Change from baseline in non-invasive marker fibroscan® aspartate aminotransferase (FAST) score
Timepoint [1] 0 0
52 Weeks
Secondary outcome [2] 0 0
Change from baseline in non-invasive marker enhanced liver fibrosis (ELF) score
Timepoint [2] 0 0
52 Weeks
Secondary outcome [3] 0 0
Change from baseline in non-invasive marker pro-peptide of type 3 procollagen (Pro-C3)
Timepoint [3] 0 0
52 Weeks
Secondary outcome [4] 0 0
Change from baseline in non-invasive marker liver stiffness assessed by transient elastography (kPa, CAP)
Timepoint [4] 0 0
52 Weeks
Secondary outcome [5] 0 0
Change from baseline in lipoproteins
Timepoint [5] 0 0
52 Weeks
Secondary outcome [6] 0 0
Change from baseline in markers of glycemic control: HbA1c (%)
Timepoint [6] 0 0
52 Weeks
Secondary outcome [7] 0 0
Change from baseline in markers of glycemic control: adiponectin (mg/L)
Timepoint [7] 0 0
52 Weeks
Secondary outcome [8] 0 0
Change from baseline in markers of liver injury
Timepoint [8] 0 0
52 Weeks
Secondary outcome [9] 0 0
Change from baseline in markers of liver injury: uric acid (mg/dL)
Timepoint [9] 0 0
52 Weeks
Secondary outcome [10] 0 0
Change from baseline in body weight (kg)
Timepoint [10] 0 0
52 Weeks

Eligibility
Key inclusion criteria
Main Study Only:

* Males and non-pregnant, non-lactating females between 18 - 80 (between 19-80 in the Republic of Korea) years of age inclusive, on the day of signing informed consent
* 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
* Suspected or confirmed diagnosis of NASH/MASH or NAFLD/MASLD or non-invasively diagnosed NASH/MASH or NAFLD/MASLD

Open-Label Rollover

* Prior participation in the placebo arm of a previous Akero Phase 2 study
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, including but not limited to: alcoholic liver disease, autoimmune disorders (e.g., primary biliary cholangitis [PBC], primary sclerosing cholangitis [PSC], autoimmune hepatitis), drug induced hepatotoxicity, Wilson disease, clinically significant iron overload, or alpha-1-antitrypsin deficiency
* Type 1 or unstable Type 2 diabetes

A reduced list of inclusion and exclusion criteria apply to participants in the open-label rollover extension.

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
10/11/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/10/2026
Actual
Sample size
Target
700
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 - Clayton
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
3168 - Clayton
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
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
Iowa
Country [10] 0 0
United States of America
State/province [10] 0 0
Kansas
Country [11] 0 0
United States of America
State/province [11] 0 0
Louisiana
Country [12] 0 0
United States of America
State/province [12] 0 0
Maryland
Country [13] 0 0
United States of America
State/province [13] 0 0
Massachusetts
Country [14] 0 0
United States of America
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Michigan
Country [15] 0 0
United States of America
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Missouri
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United States of America
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Nevada
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United States of America
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New Jersey
Country [18] 0 0
United States of America
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New Mexico
Country [19] 0 0
United States of America
State/province [19] 0 0
New York
Country [20] 0 0
United States of America
State/province [20] 0 0
North Carolina
Country [21] 0 0
United States of America
State/province [21] 0 0
Ohio
Country [22] 0 0
United States of America
State/province [22] 0 0
Pennsylvania
Country [23] 0 0
United States of America
State/province [23] 0 0
South Carolina
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United States of America
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Tennessee
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United States of America
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Texas
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United States of America
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Utah
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United States of America
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Virginia
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United States of America
State/province [28] 0 0
Washington
Country [29] 0 0
Argentina
State/province [29] 0 0
Buenos Aires
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Argentina
State/province [30] 0 0
Distrito Federal
Country [31] 0 0
Canada
State/province [31] 0 0
Alberta
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Canada
State/province [32] 0 0
Ontario
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Canada
State/province [33] 0 0
Quebec
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India
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Delhi
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India
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Gujarat
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India
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Kerala
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India
State/province [37] 0 0
Maharashtra
Country [38] 0 0
India
State/province [38] 0 0
Punjab
Country [39] 0 0
India
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Rajasthan
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India
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Tamil Nadu
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India
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Telangana
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India
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Uttar Pradesh
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India
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West Bengal
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Israel
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Central District
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Israel
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Haifa District
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Israel
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Northern District
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Israel
State/province [47] 0 0
Jerusalem
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Israel
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Tel Aviv
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Korea, Republic of
State/province [49] 0 0
Daegu Gwang'yeogsi
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Korea, Republic of
State/province [50] 0 0
Gyeonggi-Do
Country [51] 0 0
Korea, Republic of
State/province [51] 0 0
Gyeonggi-do
Country [52] 0 0
Korea, Republic of
State/province [52] 0 0
Gyeongsangbugdo
Country [53] 0 0
Korea, Republic of
State/province [53] 0 0
Seoul Teugbyeolsi [Seoul-T'ukpyolshi]
Country [54] 0 0
Korea, Republic of
State/province [54] 0 0
Seoul Teugbyeolsi
Country [55] 0 0
Puerto Rico
State/province [55] 0 0
Manatí
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Puerto Rico
State/province [56] 0 0
San Juan
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Switzerland
State/province [57] 0 0
Solothurn
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Switzerland
State/province [58] 0 0
Bern
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Switzerland
State/province [59] 0 0
Sankt Gallen
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Taiwan
State/province [60] 0 0
Changhua
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Taiwan
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Taichung
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Taiwan
State/province [62] 0 0
Tainan
Country [63] 0 0
Taiwan
State/province [63] 0 0
Taipei City
Country [64] 0 0
Turkey
State/province [64] 0 0
Ankara
Country [65] 0 0
Turkey
State/province [65] 0 0
Izmir
Country [66] 0 0
Turkey
State/province [66] 0 0
Bursa
Country [67] 0 0
Turkey
State/province [67] 0 0
Rize
Country [68] 0 0
United Kingdom
State/province [68] 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
The aim of this study is to assess the safety and tolerability of EFX compared to placebo in subjects with non-invasively diagnosed NASH/MASH and NAFLD/MASLD.
Trial website
https://clinicaltrials.gov/study/NCT06161571
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06161571