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A Study of Efruxifermin in Subjects With Histologically Confirmed Nonalcoholic Steatohepatitis (NASH)

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: NCT03976401
Recruitment Status : Active, not recruiting
First Posted : June 6, 2019
Last Update Posted : October 19, 2020
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 administered for 16 weeks in subjects with biopsy proven F1 - F4 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 : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Efruxifermin in Subjects With Nonalcoholic Steatohepatitis (NASH)
Actual Study Start Date : May 28, 2019
Actual Primary Completion Date : March 7, 2020
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: EFX Dose 1
Main Study
Drug: EFX
Administered by subcutaneous injection

Experimental: EFX Dose 2
Main Study
Drug: EFX
Administered by subcutaneous injection

Experimental: EFX Dose 3
Main Study
Drug: EFX
Administered by subcutaneous injection

Placebo Comparator: Placebo
Main Study
Drug: Placebo
Administered by subcutaneous injection

Experimental: EFX Dose (Cohort C) Drug: EFX
Administered by subcutaneous injection

Placebo Comparator: Placebo (Cohort C) Drug: Placebo
Administered by subcutaneous injection




Primary Outcome Measures :
  1. Main: Change from baseline in hepatic fat fraction assessed by MRI-PDFF [ Time Frame: 12 Weeks ]

Secondary Outcome Measures :
  1. Main: Percent change from baseline in hepatic fat fraction assessed by MRI-PDFF [ Time Frame: 12 Weeks ]
  2. Main: The responder: patients who achieved a clinically meaningful relative reduction of at least 30% in liver fat content as measured by MRI-PDFF [ Time Frame: 12 Weeks ]
  3. Main: Safety and tolerability of EFX in subjects with NASH: Number of participants with treatment-related adverse events and serious adverse events as assessed by CTCAE v5.0 [ Time Frame: 20 Weeks ]

    Clinical and laboratory AEs will be coded using the Medical Dictionary for Regulatory Activities (MedDRA). System Organ Class (SOC), High-Level Group Term (HLGT), High Level Term (HLT), Preferred Term (PT), and Lower-Level Term (LLT) will be attached to the clinical database. AE severity will be graded using the CTCAE.

    Summaries (number and percentage of subjects) of TEAEs and SAEs by SOC and PT will be provided by treatment group. Treatment-emergent AEs will also be summarized by relationship to study drugs and severity. In addition, TEAEs leading to premature discontinuation of study drugs and study, and SAEs leading to death will be summarized and listed.


  4. Main: Responder based on NAFLD Activity Score (NAS) system: patients who had a decrease of ≥ 2 points in NAS with at least a 1-point reduction in either lobular inflammation or hepatocellular ballooning and with no concurrent worsening of fibrosis stage [ Time Frame: 24 Weeks ]
  5. Main: Change from baseline in ALT [ Time Frame: 12 Weeks ]
  6. Cohort C: Change from baseline in liver stiffness assessed by FibroScan® [ Time Frame: 16 Weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Males and non-pregnant, non-lactating females between 18 - 80 years of age inclusive, based on the date of the screening visit.
  • Main Study only: Body mass index (BMI) > 25 kg/m^2 (unless the patient has biopsy-proven NASH documented within the last 2 years).
  • Main Study only: Must have confirmation of ≥ 10% liver fat content on MRI-PDFF at screening.
  • Main Study only: Biopsy-proven NASH. Must have had a liver biopsy within 180 days of randomization with fibrosis stage 1 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)
  • Cohort C only: FibroScan® measurement > 13.1 kPa.
  • Cohort C only: Cirrhosis due to NASH. Liver biopsy consistent with F4 fibrosis according to the NAS system, confirmed by the central or local reader.

Exclusion Criteria:

  • Weight gain or loss > 5% in the 3 months prior to randomization or > 10% in the 6 months prior to screening.
  • Type 1 and insulin-dependent Type 2 diabetes.
  • Poorly controlled hypertension (blood pressure > 160/100).

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): NCT03976401


Locations
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United States, Arizona
Akero Clinical Study Site
Tucson, Arizona, United States, 85711
United States, Arkansas
Akero Clinical Study Site
Little Rock, Arkansas, United States, 72117
United States, California
Akero Clinical Study Site
Huntington Park, California, United States, 90255
Akero Clinical Study Site
Los Angeles, California, United States, 90036
Akero Clinical Study Site
Los Angeles, California, United States, 90057
Akero Clinical Study Site
Panorama City, California, United States, 91402
Akero Clinical Study Site
Poway, California, United States, 92064
United States, Florida
Akero Clinical Study Site
Boca Raton, Florida, United States, 33434
Akero Clinical Study Site
Lakewood Ranch, Florida, United States, 34211
Akero Clinical Study Site
Miami, Florida, United States, 33156
Akero Clinical Study Site
New Port Richey, Florida, United States, 34653
Akero Clinical Study Site
Ocoee, Florida, United States, 34761
Akero Clinical Study Site
Port Orange, Florida, United States, 32127
Akero Clinical Study Site
Sarasota, Florida, United States, 34240
United States, Louisiana
Akero Clinical Study Site
Baton Rouge, Louisiana, United States, 70809
Akero Clinical Study Site
Marrero, Louisiana, United States, 70072
United States, Missouri
Akero Clinical Study Site
Kansas City, Missouri, United States, 64131
United States, New Jersey
Akero Clinical Study Site
Berlin, New Jersey, United States, 08009
United States, Tennessee
Akero Clinical Study Site
Chattanooga, Tennessee, United States, 37421
United States, Texas
Akero Clinical Study Site
Cedar Park, Texas, United States, 78613
Akero Clinical Study Site
Dallas, Texas, United States, 75246
Akero Clinical Study Site
Edinburg, Texas, United States, 78539
Akero Clinical Study Site
Fort Worth, Texas, United States, 76104
Akero Clinical Study Site
San Antonio, Texas, United States, 78215
Akero Clinical Study Site
San Antonio, Texas, United States, 78229
Akero Clinical Study Site
Webster, Texas, United States, 77598
Puerto Rico
Akero Clinical Study Site
San Juan, Puerto Rico, 00927
Sponsors and Collaborators
Akero Therapeutics, Inc
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Responsible Party: Akero Therapeutics, Inc
ClinicalTrials.gov Identifier: NCT03976401    
Other Study ID Numbers: AK-US-001-0101
First Posted: June 6, 2019    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020

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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