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A Study of AKR-001 in Subjects With Histologically Confirmed Nonalcoholic Steatohepatitis (NASH)

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ClinicalTrials.gov Identifier: NCT03976401
Recruitment Status : Recruiting
First Posted : June 6, 2019
Last Update Posted : May 12, 2020
Sponsor:
Information provided by (Responsible Party):
Akero Therapeutics, Inc

Tracking Information
First Submitted Date  ICMJE June 3, 2019
First Posted Date  ICMJE June 6, 2019
Last Update Posted Date May 12, 2020
Actual Study Start Date  ICMJE May 28, 2019
Actual Primary Completion Date March 7, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 15, 2020)
Main: Change from baseline in hepatic fat fraction assessed by MRI-PDFF [ Time Frame: 12 Weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 4, 2019)
Change from baseline in hepatic fat fraction assessed by MRI-PDFF [ Time Frame: 12 Weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 15, 2020)
  • Main: Percent change from baseline in hepatic fat fraction assessed by MRI-PDFF [ Time Frame: 12 Weeks ]
  • 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 ]
  • Main: Safety and tolerability of AKR-001 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.
  • 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 ]
  • Main: Change from baseline in ALT [ Time Frame: 12 Weeks ]
  • Cohort C: Change from baseline in liver stiffness assessed by FibroScan® [ Time Frame: 16 Weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 4, 2019)
  • Percent change from baseline in hepatic fat fraction assessed by MRI-PDFF [ Time Frame: 12 Weeks ]
  • 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 ]
  • Safety and tolerability of AKR-001 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of AKR-001 in Subjects With Histologically Confirmed Nonalcoholic Steatohepatitis (NASH)
Official Title  ICMJE A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of AKR-001 in Subjects With Nonalcoholic Steatohepatitis (NASH)
Brief Summary This is a multi-center evaluation of AKR-001 in a randomized, double-blind, placebo-controlled study administered for 16 weeks in subjects with biopsy proven F1 - F4 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: AKR-001
    Administered by subcutaneous injection
  • Drug: Placebo
    Administered by subcutaneous injection
Study Arms  ICMJE
  • Experimental: AKR-001 Dose 1
    Main Study
    Intervention: Drug: AKR-001
  • Experimental: AKR-001 Dose 2
    Main Study
    Intervention: Drug: AKR-001
  • Experimental: AKR-001 Dose 3
    Main Study
    Intervention: Drug: AKR-001
  • Placebo Comparator: Placebo
    Main Study
    Intervention: Drug: Placebo
  • Experimental: AKR-001 Dose (Cohort C)
    Intervention: Drug: AKR-001
  • Placebo Comparator: Placebo (Cohort C)
    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: January 15, 2020)
110
Original Estimated Enrollment  ICMJE
 (submitted: June 4, 2019)
80
Estimated Study Completion Date  ICMJE December 2020
Actual Primary Completion Date March 7, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Akero Study Director 650-487-6488 akr001@akerotx.com
Listed Location Countries  ICMJE Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03976401
Other Study ID Numbers  ICMJE AK-US-001-0101
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 Not Provided
Responsible Party Akero Therapeutics, Inc
Study Sponsor  ICMJE Akero Therapeutics, Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Akero Therapeutics, Inc
Verification Date May 2020

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