A Study of Efruxifermin in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH) (Symmetry)
NCT ID: NCT05039450
Last Updated: 2025-04-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
182 participants
INTERVENTIONAL
2021-07-30
2025-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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EFX 28 mg (Main Study)
EFX
Investigational drug, Efruxifermin
EFX 50 mg (Main Study)
EFX
Investigational drug, Efruxifermin
Placebo (Main Study)
Placebo
Placebo
EFX 50 mg (Cohort D)
EFX
Investigational drug, Efruxifermin
Placebo (Cohort D)
Placebo
Placebo
Interventions
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EFX
Investigational drug, Efruxifermin
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
* Main Study Only: Previous history or presence of Type 2 diabetes or 2 out of 4 components of metabolic syndrome (obesity, dyslipidemia, elevated blood pressure, elevated fasting glucose).
* Main Study Only: Biopsy-proven compensated cirrhosis due to NASH.
* Cohort D Only: Diagnosis of type 2 diabetes
* Cohort D Only: Use of GLP-1R agonist for at least 90 days
* Cohort D Only: Biopsy-proven liver fibrosis stages 1, 2, or 3
Exclusion Criteria
* Type 1 diabetes or uncontrolled Type 2 diabetes
* Cohort D Only: Weight loss \> 5% in the 90 days prior to screening
* Cohort D Only: Presence of cirrhosis on liver biopsy
18 Years
75 Years
ALL
No
Sponsors
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Akero Therapeutics, Inc
INDUSTRY
Responsible Party
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Locations
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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
Pasadena, California, United States
Akero Clinical Study Site
Englewood, Colorado, United States
Akero Clinical Study Site
Clearwater, Florida, United States
Akero Clinical Study Site
Fort Myers, Florida, United States
Akero Clinical Study Site
Fort Myers, Florida, United States
Akero Clinical Study Site
Hialeah Gardens, Florida, United States
Akero Clinical Study Site
Lakewood Rch, Florida, United States
Akero Clinical Study Site
Miami Lakes, Florida, United States
Akero Clinical Study Site
Ocala, 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
Las Vegas, 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
Dallas, Texas, United States
Akero Clinical Study Site
Edinburg, Texas, United States
Akero Clinical Study Site
Edinburg, Texas, United States
Akero Clinical Study Site
Fort Worth, Texas, United States
Akero Clinical Study Site
Fort Worth, Texas, United States
Akero Clinical Study Site
Houston, Texas, United States
Akero Clinical Study Site
Houston, Texas, United States
Akero Clinical Study Site
San Antonio, Texas, United States
Akero Clinical Study Site
Waco, Texas, United States
Akero Clinical Study Site
Webster, Texas, United States
Akero Clinical Study Site
Wichita Falls, Texas, United States
Akero Clinical Study Site
Ogden, Utah, United States
Akero Clinical Study Site
Richmond, Virginia, United States
Akero Clinical Study Site
Mexico City, , Mexico
Akero Clinical Study Site
Monterrey, , Mexico
Akero Clinical Study Site
San Juan, , Puerto Rico
Countries
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References
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Noureddin M, Rinella ME, Chalasani NP, Neff GW, Lucas KJ, Rodriguez ME, Rudraraju M, Patil R, Behling C, Burch M, Chan DC, Tillman EJ, Zari A, de Temple B, Shringarpure R, Jain M, Rolph T, Cheng A, Yale K. Efruxifermin in Compensated Liver Cirrhosis Caused by MASH. N Engl J Med. 2025 Jun 26;392(24):2413-2424. doi: 10.1056/NEJMoa2502242. Epub 2025 May 9.
Harrison SA, Frias JP, Lucas KJ, Reiss G, Neff G, Bollepalli S, Su Y, Chan D, Tillman EJ, Moulton A, de Temple B, Zari A, Shringarpure R, Rolph T, Cheng A, Yale K. Safety and Efficacy of Efruxifermin in Combination With a GLP-1 Receptor Agonist in Patients With NASH/MASH and Type 2 Diabetes in a Randomized Phase 2 Study. Clin Gastroenterol Hepatol. 2025 Jan;23(1):103-113. doi: 10.1016/j.cgh.2024.02.022. Epub 2024 Mar 4.
Other Identifiers
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AK-US-001-0103
Identifier Type: -
Identifier Source: org_study_id
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