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

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ClinicalTrials.gov Identifier: NCT04767529
Recruitment Status : Recruiting
First Posted : February 23, 2021
Last Update Posted : July 28, 2021
Sponsor:
Information provided by (Responsible Party):
Akero Therapeutics, Inc

Tracking Information
First Submitted Date  ICMJE February 16, 2021
First Posted Date  ICMJE February 23, 2021
Last Update Posted Date July 28, 2021
Actual Study Start Date  ICMJE February 16, 2021
Estimated Primary Completion Date September 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 22, 2021)
Change from baseline in liver fibrosis with no worsening steatohepatitis assessed by NASH CRN system [ Time Frame: 24 Weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 10, 2021)
  • Resolution of steatohepatitis with no worsening of fibrosis assessed by the NASH CRN system [ Time Frame: 24 Weeks, 96 Weeks ]
  • Change from baseline in liver fibrosis with no worsening of steatohepatitis assessed by the NASH CRN system [ Time Frame: 96 Weeks ]
  • Responder based on NASH CRN: patients who had a decrease of ≥ one point in fibrosis score [ Time Frame: 24 Weeks, 96 Weeks ]
  • Change from baseline in hepatic fat fraction [ Time Frame: 24 Weeks, 96 Weeks ]
  • Change from baseline of lipoproteins - Non-HDL-C, HDL-C, and LDL-C [ Time Frame: 24 Weeks, 48 Weeks, 96 Weeks ]
  • Change from baseline of markers of glycemic control - HbA1c [ Time Frame: 24 Weeks, 48 Weeks, 96 Weeks ]
  • Change from baseline of markers of glycemic control - C-Peptide [ Time Frame: 24 Weeks, 48 Weeks, 96 Weeks ]
  • Change from baseline of markers of glycemic control - Adiponectin [ Time Frame: 24 Weeks, 48 Weeks, 96 Weeks ]
  • Change from baseline of markers of glycemic control - HOMA-IR [ Time Frame: 24 Weeks, 48 Weeks, 96 Weeks ]
  • Change from baseline of non-invasive fibrosis biomarkers - ELF [ Time Frame: 24 Weeks, 48 Weeks, 96 Weeks ]
  • Change from baseline of non-invasive fibrosis biomarkers - Pro-C3 [ Time Frame: 24 Weeks, 48 Weeks, 96 Weeks ]
  • Change from baseline of non-invasive fibrosis biomarkers - NIS-4 [ Time Frame: 24 Weeks, 48 Weeks, 96 Weeks ]
  • Change from baseline of non-invasive fibrosis biomarkers - liver stiffness assessed by transient elastography (FibroScan®) [ Time Frame: 24 Weeks, 48 Weeks, 96 Weeks ]
  • Change from baseline of body weight [ Time Frame: 24 Weeks, 48 Weeks, 96 Weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 22, 2021)
  • Resolution of steatohepatitis with no worsening of fibrosis assessed by the NASH CRN system [ Time Frame: 24 Weeks, 240 Weeks ]
  • Change from baseline in liver fibrosis with no worsening of steatohepatitis assessed by the NASH CRN system [ Time Frame: 240 Weeks ]
  • Responder based on NASH CRN: patients who had a decrease of ≥ one point in fibrosis score [ Time Frame: 24 Weeks, 240 Weeks ]
  • Change from baseline in hepatic fat fraction [ Time Frame: 24 Weeks ]
  • Change from baseline of lipoproteins - Non-HDL-C, HDL-C, and LDL-C [ Time Frame: 24 Weeks, 52 Weeks, 240 Weeks ]
  • Change from baseline of markers of glycemic control - HbA1c [ Time Frame: 24 Weeks, 52 Weeks, 240 Weeks ]
  • Change from baseline of markers of glycemic control - C-Peptide [ Time Frame: 24 Weeks, 52 Weeks, 240 Weeks ]
  • Change from baseline of markers of glycemic control - Adiponectin [ Time Frame: 24 Weeks, 52 Weeks, 240 Weeks ]
  • Change from baseline of markers of glycemic control - HOMA-IR [ Time Frame: 24 Weeks, 52 Weeks, 240 Weeks ]
  • Change from baseline of non-invasive fibrosis biomarkers - ELF [ Time Frame: 24 Weeks, 52 Weeks, 240 Weeks ]
  • Change from baseline of non-invasive fibrosis biomarkers - Pro-C3 [ Time Frame: 24 Weeks, 52 Weeks, 240 Weeks ]
  • Change from baseline of non-invasive fibrosis biomarkers - NIS-4 [ Time Frame: 24 Weeks, 52 Weeks, 240 Weeks ]
  • Change from baseline of non-invasive fibrosis biomarkers - liver stiffness assessed by transient elastography (FibroScan®) [ Time Frame: 24 Weeks, 52 Weeks, 240 Weeks ]
  • Change from baseline of body weight [ Time Frame: 24 Weeks, 52 Weeks, 240 Weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Efruxifermin in Non-Cirrhotic Subjects With Histologically Confirmed Nonalcoholic Steatohepatitis (NASH)
Official Title  ICMJE A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Efruxifermin in Non-Cirrhotic Subjects With Nonalcoholic Steatohepatitis (NASH)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE NASH - Nonalcoholic Steatohepatitis
Intervention  ICMJE
  • Drug: EFX
    Administered by subcutaneous injection
  • Drug: Placebo
    Administered by subcutaneous injection
Study Arms  ICMJE
  • Experimental: EFX 28 mg
    Intervention: Drug: EFX
  • Experimental: EFX 50 mg
    Intervention: Drug: EFX
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 22, 2021)
160
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2024
Estimated Primary Completion Date September 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Akero Study Director 650-487-6488 HarmonyStudies@akerotx.com
Listed Location Countries  ICMJE Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04767529
Other Study ID Numbers  ICMJE AK-US-001-0102
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Akero Therapeutics, Inc
Study Sponsor  ICMJE Akero Therapeutics, Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Akero Study Director Study Director
PRS Account Akero Therapeutics, Inc
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP