Clinical Trial Details

Trial ID: L0209
Source ID: NCT05039450
Associated Drug: Efruxifermin
Title: A Study of Efruxifermin in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH) (Symmetry)
Acronym: --
Status: Recruiting
Study Results: No Results Available
Results: --
Conditions: NASH - Nonalcoholic Steatohepatitis
Interventions: Drug: EFX|Drug: Placebo
Outcome Measures: Change from baseline in fibrosis with no worsening steatohepatitis assessed by NASH CRN system|Resolution of NASH with no worsening of fibrosis assessed by the NASH CRN system|Change from baseline in fibrosis in subjects with no worsening of steatohepatitis assessed by the NASH CRN system|Change from baseline in non-invasive markers of fibrosis|Change from baseline in lipoproteins|Change from baseline of markers in insulin sensitivity and glycemic control|Change from baseline in body weight|To assess the immunogenicity of EFX|To assess the safety and tolerability of EFX
Sponsor/Collaborators: Akero Therapeutics, Inc
Gender: All
Age: 18 Years to 75 Years ?? (Adult, Older Adult)
Phases: Phase 2
Enrollment: 200
Study Type: Interventional
Study Designs: Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
Start Date: July 30, 2021
Completion Date: April 2024
Results First Posted: --
Last Update Posted: February 17, 2022
Locations: Akero Clinical Study Site, Chandler, Arizona, United States|Akero Clinical Study Site, Glendale, Arizona, United States|Akero Clinical Study Site, Tucson, Arizona, United States|Akero Clinical Study Site, Tucson, Arizona, United States|Akero Clinical Study Site, North Little Rock, Arkansas, United States|Akero Clinical Study Site, Fresno, California, United States|Akero Clinical Study Site, Long Beach, California, United States|Akero Clinical Study Site, Los Angeles, California, United States|Akero Clinical Study Site, Rialto, California, United States|Akero Clinical Study Site, Fort Myers, Florida, United States|Akero Clinical Study Site, Hialeah Gardens, Florida, United States|Akero Clinical Study Site, Inverness, Florida, United States|Akero Clinical Study Site, Lakewood Ranch, Florida, United States|Akero Clinical Study Site, Miami Lakes, Florida, United States|Akero Clinical Study Site, Miami, 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, Ocala, Florida, United States|Akero Clinical Study Site, Port Orange, Florida, United States|Akero Clinical Study Site, Sarasota, Florida, United States|Akero Clinical Study Site, South Bend, Indiana, United States|Akero Clinical Study Site, Topeka, Kansas, United States|Akero Clinical Study Site, Bastrop, Louisiana, United States|Akero Clinical Study Site, Marrero, Louisiana, United States|Akero Clinical Study Site, Monroe, Louisiana, United States|Akero Clinical Study Site, Las Vegas, Nevada, United States|Advanced Research Institute, Reno, Nevada, United States|Akero Clinical Study Site, Concord, North Carolina, United States|Akero Clinical Study Site, Fayetteville, North Carolina, United States|Akero Clinical Study Site, Morehead City, North Carolina, United States|Akero Clinical Study Site, Springboro, Ohio, United States|Akero Clinical Study Site, Westlake, Ohio, United States|Akero Clinical Study Site, Greenville, South Carolina, United States|Akero Clinical Study Site, Greenwood, South Carolina, United States|Akero Clinical Study Site, Summerville, South Carolina, United States|Akero Clinical Study Site, Nashville, Tennessee, United States|Akero Clinical Study Site, Austin, Texas, United States|Akero Clinical Study Site, Edinburg, Texas, United States|Akero Clinical Study Site, Edinburg, Texas, United States|Akero Clinical Study Site, El Paso, Texas, United States|Akero Clinical Study Site, Fort Worth, Texas, United States|Akero Clinical Study Site, Houston, Texas, United States|Akero Clinical Study Site, San Antonio, Texas, United States|Akero Clinical Study Site, Ogden, Utah, United States|Akero Clinical Study Site, Sandy, Utah, United States|Akero Clinical Study Site, San Juan, Puerto Rico
URL: https://ClinicalTrials.gov/show/NCT05039450

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
D080 Citrulline Chemical drug DB00155 -- -- Under clinical trials Details
D182 Insulin Biological drug DB00030 INSR agonist; CPE modulator&product of -- Under clinical trials Details