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A Study of Efruxifermin in Non-Cirrhotic Subjects With Histologically Confirmed Nonalcoholic Steatohepatitis (NASH) (Harmony)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04767529
Recruitment Status : Active, not recruiting
First Posted : February 23, 2021
Last Update Posted : April 21, 2023
Sponsor:
Information provided by (Responsible Party):
Akero Therapeutics, Inc

Study Description
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Brief Summary:
This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in non-cirrhotic subjects with biopsy-proven F2 - F3 NASH.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 128 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 Non-Cirrhotic Subjects With Nonalcoholic Steatohepatitis (NASH)
Actual Study Start Date : February 16, 2021
Actual Primary Completion Date : July 25, 2022
Estimated Study Completion Date : May 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: EFX 28 mg Drug: EFX
Administered by subcutaneous injection
Experimental: EFX 50 mg Drug: EFX
Administered by subcutaneous injection
Placebo Comparator: Placebo Drug: Placebo
Administered by subcutaneous injection


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline in liver fibrosis with no worsening steatohepatitis assessed by NASH CRN system [ Time Frame: 24 Weeks ]

Secondary Outcome Measures :
  1. Resolution of steatohepatitis with no worsening of fibrosis assessed by the NASH CRN system [ Time Frame: 24 Weeks, 96 Weeks ]
  2. Change from baseline in liver fibrosis with no worsening of steatohepatitis assessed by the NASH CRN system [ Time Frame: 96 Weeks ]
  3. Responder based on NASH CRN: patients who had a decrease of ≥ one point in fibrosis score [ Time Frame: 24 Weeks, 96 Weeks ]
  4. Change from baseline in hepatic fat fraction [ Time Frame: 24 Weeks, 96 Weeks ]
  5. Change from baseline of lipoproteins - Non-HDL-C, HDL-C, and LDL-C [ Time Frame: 24 Weeks, 48 Weeks, 96 Weeks ]
  6. Change from baseline of markers of glycemic control - HbA1c [ Time Frame: 24 Weeks, 48 Weeks, 96 Weeks ]
  7. Change from baseline of markers of glycemic control - C-Peptide [ Time Frame: 24 Weeks, 48 Weeks, 96 Weeks ]
  8. Change from baseline of markers of glycemic control - Adiponectin [ Time Frame: 24 Weeks, 48 Weeks, 96 Weeks ]
  9. Change from baseline of markers of glycemic control - HOMA-IR [ Time Frame: 24 Weeks, 48 Weeks, 96 Weeks ]
  10. Change from baseline of non-invasive fibrosis biomarkers - ELF [ Time Frame: 24 Weeks, 48 Weeks, 96 Weeks ]
  11. Change from baseline of non-invasive fibrosis biomarkers - Pro-C3 [ Time Frame: 24 Weeks, 48 Weeks, 96 Weeks ]
  12. Change from baseline of non-invasive fibrosis biomarkers - NIS-4 [ Time Frame: 24 Weeks, 48 Weeks, 96 Weeks ]
  13. Change from baseline of non-invasive fibrosis biomarkers - liver stiffness assessed by transient elastography (FibroScan®) [ Time Frame: 24 Weeks, 48 Weeks, 96 Weeks ]
  14. Change from baseline of body weight [ Time Frame: 24 Weeks, 48 Weeks, 96 Weeks ]

Eligibility Criteria
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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 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 > 8.5 kPa.

  • Biopsy-proven NASH. Must have had a liver biopsy obtained ≤ 180 days prior to randomization with fibrosis stage 2 to 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).

Exclusion Criteria:

  • Weight loss > 5% in the 3 months prior to screening until randomization or from the time of the diagnostic liver biopsy until randomization, whichever is longer.
  • Presence of cirrhosis on liver biopsy (stage 4 fibrosis).
  • Type 1 or uncontrolled Type 2 diabetes.

Other inclusion and exclusion criteria may apply.

Contacts and Locations
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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): NCT04767529


Locations
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Sponsors and Collaborators
Akero Therapeutics, Inc
Investigators
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Study Director: Akero Study Director Study Director
More Information
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Responsible Party: Akero Therapeutics, Inc
ClinicalTrials.gov Identifier: NCT04767529    
Other Study ID Numbers: AK-US-001-0102
First Posted: February 23, 2021    Key Record Dates
Last Update Posted: April 21, 2023
Last Verified: April 2023
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