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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 : October 14, 2019
Sponsor:
Information provided by (Responsible Party):
Akero Therapeutics, Inc

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 - F3 NASH.

Condition or disease Intervention/treatment Phase
NASH - Nonalcoholic Steatohepatitis Drug: AKR-001 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 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 AKR-001 in Subjects With Nonalcoholic Steatohepatitis (NASH)
Actual Study Start Date : May 28, 2019
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : June 2020


Arm Intervention/treatment
Experimental: AKR-001 Dose 1 Drug: AKR-001
Administered by subcutaneous injection

Experimental: AKR-001 Dose 2 Drug: AKR-001
Administered by subcutaneous injection

Experimental: AKR-001 Dose 3 Drug: AKR-001
Administered by subcutaneous injection

Placebo Comparator: Placebo Drug: Placebo
Administered by subcutaneous injection




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

Secondary Outcome Measures :
  1. Percent change from baseline in hepatic fat fraction assessed by MRI-PDFF [ Time Frame: 12 Weeks ]
  2. 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. 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.


  4. 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. Change from baseline in ALT [ Time Frame: 12 Weeks ]


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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.
  • Body mass index (BMI) > 25 kg/m^2 (unless the patient has biopsy-proven NASH documented within the last 2 years).
  • Must have confirmation of ≥ 10% liver fat content on MRI-PDFF at screening.
  • 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)

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.
  • Presence of cirrhosis on liver biopsy (stage 4 fibrosis).
  • 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


Contacts
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Contact: Akero Study Director 650-487-6488 akr001@akerotx.com

Locations
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United States, Arizona
Akero Clinical Study Site Recruiting
Tucson, Arizona, United States, 85711
Contact: Akero Site 210         
United States, Arkansas
Akero Clinical Study Site Recruiting
Little Rock, Arkansas, United States, 72117
Contact: Akero Site 214         
United States, California
Akero Clinical Study Site Recruiting
Huntington Park, California, United States, 90255
Contact: Akero Site 207         
Akero Clinical Study Site Recruiting
Los Angeles, California, United States, 90036
Contact: Akero Site 101         
Akero Clinical Study Site Recruiting
Los Angeles, California, United States, 90057
Contact: Akero Site 206         
Akero Clinical Study Site Recruiting
Panorama City, California, United States, 91402
Contact: Akero Site 217         
Akero Clinical Study Site Recruiting
Poway, California, United States, 92064
Contact: Akero Site 216         
United States, Florida
Akero Clinical Study Site Recruiting
Boca Raton, Florida, United States, 33434
Contact: Akero Site 201         
Akero Clinical Study Site Recruiting
Lakewood Ranch, Florida, United States, 34211
Contact: Akero Site 203         
Akero Clinical Study Site Recruiting
Ocoee, Florida, United States, 34761
Contact: Akero Site 107         
Akero Clinical Study Site Recruiting
Port Orange, Florida, United States, 32127
Contact: Akero Site 105         
United States, Louisiana
Akero Clinical Study Site Recruiting
Baton Rouge, Louisiana, United States, 70809
Contact: Akero Site 209         
Akero Clinical Study Site Recruiting
Marrero, Louisiana, United States, 70072
Contact: Akero Site 102         
United States, Missouri
Akero Clinical Study Site Recruiting
Kansas City, Missouri, United States, 64131
Contact: Akero Site 208         
United States, New Jersey
Akero Clinical Study Site Recruiting
Berlin, New Jersey, United States, 08009
Contact: Akero Site 104         
United States, Tennessee
Akero Clinical Study Site Recruiting
Chattanooga, Tennessee, United States, 37421
Contact: Akero Site 106         
United States, Texas
Akero Clinical Study Site Recruiting
Cedar Park, Texas, United States, 78613
Contact: Akero Site 212         
Akero Clinical Study Site Recruiting
Dallas, Texas, United States, 75246
Contact: Akero Site 213         
Akero Clinical Study Site Recruiting
Edinburg, Texas, United States, 78539
Contact: Akero Site 205         
Akero Clinical Study Site Recruiting
Fort Worth, Texas, United States, 76104
Contact: Akero Site 211         
Akero Clinical Study Site Recruiting
San Antonio, Texas, United States, 78215
Contact: Akero Site 103         
Akero Clinical Study Site Recruiting
San Antonio, Texas, United States, 78229
Contact: Akero Site 202         
Akero Clinical Study Site Recruiting
San Antonio, Texas, United States, 78229
Contact: Akero Site 108         
Akero Clinical Study Site Recruiting
Webster, Texas, United States, 77598
Contact: Akero Site 204         
Puerto Rico
Akero Clinical Study Site Recruiting
San Juan, Puerto Rico, 00927
Contact: Akero Site 215         
Sponsors and Collaborators
Akero Therapeutics, Inc

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Responsible Party: Akero Therapeutics, Inc
ClinicalTrials.gov Identifier: NCT03976401     History of Changes
Other Study ID Numbers: AK-US-001-0101
First Posted: June 6, 2019    Key Record Dates
Last Update Posted: October 14, 2019
Last Verified: October 2019

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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