A Study of Efruxifermin in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH) (Symmetry)

NCT05039450 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: AK-US-001-0103
• Study Type: interventional
• Target: 182
• Locations: 3 countries
• Sites: 49

Brief Summary

This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in cirrhotic subjects with biopsy-proven F4 compensated NASH.

Conditions

NASH - Nonalcoholic Steatohepatitis

Outcome Measures

Primary Outcomes (1)

• Main: Change from baseline in fibrosis with no worsening steatohepatitis assessed by NASH CRN system

  Proportion of subjects who achieve ≥ 1 stage improvement in fibrosis (based on NASH CRN fibrosis score) and no worsening of steatohepatitis at Week 36.

  Week 36

Secondary Outcomes (11)

• Main: Resolution of NASH assessed by the NASH CRN system

  Week 36, Week 96

• Main: Fibrosis improvement with no worsening of NASH assessed by the NASH CRN system

  Week 36, Week 96

• Main: Change from baseline in fibrosis in subjects with no worsening of steatohepatitis assessed by the NASH CRN system

  Week 96

• Main: Change from baseline in fibrosis in subjects with no worsening of steatohepatitis assessed by the NASH CRN system

  Week 36, Week 96

• Main: Change from baseline in non-invasive markers of fibrosis

  Week 36, Week 48, Week 72, Week 96

Study Arms (5)

EFX 28 mg (Main Study)

EXPERIMENTAL

Drug: EFX

EFX 50 mg (Main Study)

EXPERIMENTAL

Drug: EFX

Placebo (Main Study)

PLACEBO COMPARATOR

Drug: Placebo

EFX 50 mg (Cohort D)

EXPERIMENTAL

Drug: EFX

Placebo (Cohort D)

PLACEBO COMPARATOR

Drug: Placebo

Interventions

EFX DRUG

Investigational drug, Efruxifermin

EFX 28 mg (Main Study); EFX 50 mg (Cohort D); EFX 50 mg (Main Study)

Placebo DRUG

Placebo

Placebo (Cohort D); Placebo (Main Study)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and non-pregnant, non-lactating females between 18-75 years of age inclusive, based on the date of signing informed consent.
• 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

You may not qualify if:

• Main Study Only: Weight loss \> 10% in the 90 days prior to screening until randomization or from the time of collection of the liver biopsy used to assess subject eligibility until randomization, whichever is longer.
• 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

Sponsors & Collaborators

• Akero Therapeutics, Inc: lead

Study Sites (49)

Akero Clinical Study Site

Chandler, Arizona, 85224, United States

Location

Akero Clinical Study Site

Glendale, Arizona, 85306, United States

Location

Akero Clinical Study Site

Tucson, Arizona, 85711, United States

Location

Akero Clinical Study Site

Tucson, Arizona, 85712, United States

Location

Akero Clinical Study Site

North Little Rock, Arkansas, 72117, United States

Location

Akero Clinical Study Site

Fresno, California, 93720, United States

Location

Akero Clinical Study Site

Long Beach, California, 90808, United States

Location

Akero Clinical Study Site

Los Angeles, California, 90036, United States

Location

Akero Clinical Study Site

Pasadena, California, 91105, United States

Location

Akero Clinical Study Site

Englewood, Colorado, 80113, United States

Location

Akero Clinical Study Site

Clearwater, Florida, 33761, United States

Location

Akero Clinical Study Site

Fort Myers, Florida, 33907, United States

Location

Akero Clinical Study Site

Fort Myers, Florida, 33912, United States

Location

Akero Clinical Study Site

Hialeah Gardens, Florida, 33016, United States

Location

Akero Clinical Study Site

Lakewood Rch, Florida, 34211, United States

Location

Akero Clinical Study Site

Miami Lakes, Florida, 33016, United States

Location

Akero Clinical Study Site

Ocala, Florida, 34471, United States

Location

Akero Clinical Study Site

Sarasota, Florida, 34240, United States

Location

Akero Clinical Study Site

South Bend, Indiana, 46635, United States

Location

Akero Clinical Study Site

Topeka, Kansas, 66606, United States

Location

Akero Clinical Study Site

Bastrop, Louisiana, 71220, United States

Location

Akero Clinical Study Site

Marrero, Louisiana, 70072, United States

Location

Akero Clinical Study Site

Las Vegas, Nevada, 89109, United States

Location

Akero Clinical Study Site

Concord, North Carolina, 28027, United States

Location

Akero Clinical Study Site

Fayetteville, North Carolina, 28304, United States

Location

Akero Clinical Study Site

Morehead City, North Carolina, 28557, United States

Location

Akero Clinical Study Site

Springboro, Ohio, 45066, United States

Location

Akero Clinical Study Site

Westlake, Ohio, 44145, United States

Location

Akero Clinical Study Site

Greenville, South Carolina, 29605, United States

Location

Akero Clinical Study Site

Greenwood, South Carolina, 29646, United States

Location

Akero Clinical Study Site

Summerville, South Carolina, 29485, United States

Location

Akero Clinical Study Site

Nashville, Tennessee, 37211, United States

Location

Akero Clinical Study Site

Austin, Texas, 78746, United States

Location

Akero Clinical Study Site

Dallas, Texas, 75246, United States

Location

Akero Clinical Study Site

Edinburg, Texas, 78504, United States

Location

Akero Clinical Study Site

Edinburg, Texas, 78539, United States

Location

Akero Clinical Study Site

Fort Worth, Texas, 75044, United States

Location

Akero Clinical Study Site

Fort Worth, Texas, 76104, United States

Location

Akero Clinical Study Site

Houston, Texas, 77030, United States

Location

Akero Clinical Study Site

Houston, Texas, 77079, United States

Location

Akero Clinical Study Site

San Antonio, Texas, 78215, United States

Location

Akero Clinical Study Site

Waco, Texas, 76710, United States

Location

Akero Clinical Study Site

Webster, Texas, 77598, United States

Location

Akero Clinical Study Site

Wichita Falls, Texas, 76301, United States

Location

Akero Clinical Study Site

Ogden, Utah, 84405, United States

Location

Akero Clinical Study Site

Richmond, Virginia, 23298, United States

Location

Akero Clinical Study Site

Mexico City, Mexico

Location

Akero Clinical Study Site

Monterrey, Mexico

Location

Akero Clinical Study Site

San Juan, 00927, Puerto Rico

Location

Related Publications (2)

• 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.

  PMID: 40341827 DERIVED

• 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.

  PMID: 38447814 DERIVED

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2021
• First Posted: September 9, 2021
• Study Start: July 30, 2021
• Primary Completion: August 25, 2023
• Study Completion: May 1, 2025
• Last Updated: April 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

PR (1); US (46); ME (2)