Clinical Trial Details

Trial ID: L0224
Source ID: NCT03976401
Associated Drug: Efruxifermin
Title: A Study of Efruxifermin in Subjects With Histologically Confirmed Nonalcoholic Steatohepatitis (NASH)
Acronym: --
Status: Completed
Study Results: No Results Available
Results: --
Conditions: NASH - Nonalcoholic Steatohepatitis
Interventions: Drug: EFX|Drug: Placebo
Outcome Measures: Main: Change from baseline in hepatic fat fraction assessed by MRI-PDFF|Main: Percent change from baseline in hepatic fat fraction assessed by MRI-PDFF|Main: The responder: patients who achieved a clinically meaningful relative reduction of at least 30% in liver fat content as measured by MRI-PDFF|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|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|Main: Change from baseline in ALT|Cohort C: Change from baseline in liver stiffness assessed by FibroScan??
Sponsor/Collaborators: Akero Therapeutics, Inc
Gender: All
Age: 18 Years to 80 Years ?? (Adult, Older Adult)
Phases: Phase 2
Enrollment: 110
Study Type: Interventional
Study Designs: Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
Start Date: May 28, 2019
Completion Date: January 10, 2022
Results First Posted: --
Last Update Posted: February 28, 2022
Locations: Akero Clinical Study Site, Tucson, Arizona, United States|Akero Clinical Study Site, Little Rock, Arkansas, United States|Akero Clinical Study Site, Huntington Park, California, United States|Akero Clinical Study Site, Los Angeles, California, United States|Akero Clinical Study Site, Los Angeles, California, United States|Akero Clinical Study Site, Panorama City, California, United States|Akero Clinical Study Site, Poway, California, United States|Akero Clinical Study Site, Boca Raton, Florida, United States|Akero Clinical Study Site, Lakewood Ranch, Florida, United States|Akero Clinical Study Site, Miami, Florida, United States|Akero Clinical Study Site, New Port Richey, Florida, United States|Akero Clinical Study Site, Ocoee, Florida, United States|Akero Clinical Study Site, Port Orange, Florida, United States|Akero Clinical Study Site, Sarasota, Florida, United States|Akero Clinical Study Site, Baton Rouge, Louisiana, United States|Akero Clinical Study Site, Marrero, Louisiana, United States|Akero Clinical Study Site, Kansas City, Missouri, United States|Akero Clinical Study Site, Berlin, New Jersey, United States|Akero Clinical Study Site, Chattanooga, Tennessee, United States|Akero Clinical Study Site, Cedar Park, Texas, United States|Akero Clinical Study Site, Dallas, Texas, United States|Akero Clinical Study Site, Edinburg, Texas, United States|Akero Clinical Study Site, Fort Worth, Texas, United States|Akero Clinical Study Site, San Antonio, Texas, United States|Akero Clinical Study Site, San Antonio, Texas, United States|Akero Clinical Study Site, Webster, Texas, United States|Akero Clinical Study Site, San Juan, Puerto Rico
URL: https://ClinicalTrials.gov/show/NCT03976401

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D414 Efruxifermin Biological drug -- Fibroblast growth factor receptor agonist anti-fibrotic, improves metabolic status Under clinical trials Details
D094 Cysteamine Chemical drug DB00847 GSS stimulant Renal drug Under clinical trials Details
D095 Cysteamine bitartrate Chemical drug DB00847 -- -- Under clinical trials Details
D328 Serine Chemical drug DB00133 SRR Improve insulin resistance Under clinical trials Details