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A Study of Efruxifermin in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH) (Symmetry)

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ClinicalTrials.gov Identifier: NCT05039450
Recruitment Status : Recruiting
First Posted : September 9, 2021
Last Update Posted : September 9, 2022
Sponsor:
Information provided by (Responsible Party):
Akero Therapeutics, Inc

Brief Summary:
This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in cirrhotic subjects with biopsy-proven F4 compensated NASH.

Condition or disease Intervention/treatment Phase
NASH - Nonalcoholic Steatohepatitis Drug: EFX Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Efruxifermin in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH)
Actual Study Start Date : July 30, 2021
Estimated Primary Completion Date : October 2023
Estimated Study Completion Date : April 2024


Arm Intervention/treatment
Experimental: EFX 28 mg (Main Study) Drug: EFX
Investigational drug, Efruxifermin

Experimental: EFX 50 mg (Main Study) Drug: EFX
Investigational drug, Efruxifermin

Placebo Comparator: Placebo (Main Study) Drug: Placebo
Placebo

Experimental: EFX 50 mg (Cohort D) Drug: EFX
Investigational drug, Efruxifermin

Placebo Comparator: Placebo (Cohort D) Drug: Placebo
Placebo




Primary Outcome Measures :
  1. Main: Change from baseline in fibrosis with no worsening steatohepatitis assessed by NASH CRN system [ Time Frame: Week 36 ]
    Proportion of subjects who achieve ≥ 1 stage improvement in fibrosis (based on NASH CRN fibrosis score) and no worsening of steatohepatitis at Week 36.


Secondary Outcome Measures :
  1. Main: Resolution of NASH with no worsening of fibrosis assessed by the NASH CRN system [ Time Frame: Week 36, Week 96 ]
    Proportion of subjects who achieve NASH resolution (defined as a NAS of 0-1 for inflammation and 0 for ballooning) as determined by the NASH CRN criteria at Week 36 and Week 96

  2. Main: Change from baseline in fibrosis in subjects with no worsening of steatohepatitis assessed by the NASH CRN system [ Time Frame: Week 96 ]
    Proportion of subjects who achieve ≥ 1 stage improvement in fibrosis (based on NASH CRN fibrosis score) and no worsening of steatohepatitis at Week 96

  3. Main: Change from baseline in fibrosis in subjects with no worsening of steatohepatitis assessed by the NASH CRN system [ Time Frame: Week 36, Week 96 ]
    Proportion of subjects who achieve ≥ 1 stage improvement in fibrosis (based on NASH CRN fibrosis score) at Week 36 and Week 96

  4. Main: Change from baseline in non-invasive markers of fibrosis [ Time Frame: Week 36, Week 48, Week 72, Week 96 ]
    Change from baseline in ELF score, Pro-C3 (ug/L),and liver stiffness assessed by liver elastography (kPa, CAP)

  5. Main: Change from baseline in lipoproteins [ Time Frame: Week 36, Week 48, Week 72, Week 96 ]
    Change from baseline in Triglycerides (mg/dL), total cholesterol (mg/dL), HDL-C (mg/dL), non-HDL-C (mg/dL), and LDL-C (mg/dL)

  6. Main: Change from baseline of markers in insulin sensitivity and glycemic control [ Time Frame: Week 36, Week 48, Week 72, Week 96 ]
    Change from baseline in HbA1c (%), C-peptide (ug/L), adiponectin (mg/L), insulin (mIU/L), and HOMA-IR

  7. Main: Change from baseline in body weight [ Time Frame: Week 36, Week 48, Week 96 ]
    Change from baseline in body weight (kg)

  8. Main: To assess the immunogenicity of EFX [ Time Frame: Through Week 96 ]
    Detect and measure ADA, including NAb, against EFX

  9. Main: To assess the safety and tolerability of EFX [ Time Frame: Through Week 96 ]
    Safety and tolerability will be assessed through the reporting of AEs, clinical laboratory tests, ECGs, ultrasounds, vital sign assessments, and concomitant medication usage

  10. Cohort D: To assess the safety and tolerability of EFX compared to placebo when added to an existing GLP-1R agonist in subjects with type 2 diabetes and liver fibrosis due to NASH [ Time Frame: Through Week 12 ]
    Safety and tolerability will be assessed through the reporting of AEs, clinical laboratory assessments, ECGs, ultrasounds, vital sign assessments, and concomitant medication usage



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and non-pregnant, non-lactating females between 18-75 years of age inclusive, based on the date of signing informed consent.
  • Main Study Only: Previous history or presence of Type 2 diabetes or 2 out of 4 components of metabolic syndrome (obesity, dyslipidemia, elevated blood pressure, elevated fasting glucose).
  • Main Study Only: Biopsy-proven compensated cirrhosis due to NASH.
  • Cohort D Only: Diagnosis of type 2 diabetes
  • Cohort D Only: Use of GLP-1R agonist for at least 90 days
  • Cohort D Only: Biopsy-proven liver fibrosis stages 1, 2, or 3

Exclusion Criteria:

  • Main Study Only: Weight loss > 10% in the 90 days prior to screening until randomization or from the time of collection of the liver biopsy used to assess subject eligibility until randomization, whichever is longer.
  • Type 1 diabetes or uncontrolled Type 2 diabetes
  • Cohort D Only: Weight loss > 5% in the 90 days prior to screening
  • Cohort D Only: Presence of cirrhosis on liver biopsy

Other inclusion and exclusion criteria may apply


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05039450


Contacts
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Contact: Akero Study Director 650-487-6488 SymmetryStudy@akerotx.com

Locations
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Sponsors and Collaborators
Akero Therapeutics, Inc
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Responsible Party: Akero Therapeutics, Inc
ClinicalTrials.gov Identifier: NCT05039450    
Other Study ID Numbers: AK-US-001-0103
First Posted: September 9, 2021    Key Record Dates
Last Update Posted: September 9, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fatty Liver
Non-alcoholic Fatty Liver Disease
Liver Diseases
Digestive System Diseases