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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EFX 28 mg (Main Study) | Experimental |
| |
| EFX 50 mg (Main Study) | Experimental |
| |
| Placebo (Main Study) | Placebo Comparator |
| |
| EFX 50 mg (Cohort D) | Experimental |
| |
| Placebo (Cohort D) | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EFX | Drug | Investigational drug, Efruxifermin |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Main: Resolution of NASH assessed by the NASH CRN system | Proportion of subjects who achieve NASH resolution (defined as a NAS of 0-1 for inflammation and 0 for ballooning) as determined by the NASH CRN criteria at Week 36 and Week 96 | Week 36, Week 96 |
| Main: Fibrosis improvement with no worsening of NASH assessed by the NASH CRN system |
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Inclusion Criteria:
Exclusion Criteria:
Other inclusion and exclusion criteria may apply
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Akero Clinical Study Site | Chandler | Arizona | 85224 | United States | ||
| Akero Clinical Study Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40341827 | Derived | 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. | |
| 38447814 |
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| Placebo | Drug | Placebo |
|
Proportion of subjects who achieve NASH resolution (defined as a NAS of 0-1 for inflammation and 0 for ballooning) and ≥ 1 stage improvement in fibrosis (based on NASH CRN fibrosis score) at Week 36 and Week 96 |
| Week 36, Week 96 |
| Main: Change from baseline in fibrosis in subjects with no worsening of steatohepatitis assessed by the 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 96 | Week 96 |
| Main: Change from baseline in fibrosis in subjects with no worsening of steatohepatitis assessed by the NASH CRN system | Proportion of subjects who achieve ≥ 1 stage improvement in fibrosis (based on NASH CRN fibrosis score) at Week 36 and Week 96 | Week 36, Week 96 |
| Main: Change from baseline in non-invasive markers of fibrosis | Change from baseline in ELF score, Pro-C3 (ug/L),and liver stiffness assessed by liver elastography (kPa, CAP) | Week 36, Week 48, Week 72, Week 96 |
| Main: Change from baseline in lipoproteins | Change from baseline in Triglycerides (mg/dL), total cholesterol (mg/dL), HDL-C (mg/dL), non-HDL-C (mg/dL), and LDL-C (mg/dL) | Week 36, Week 48, Week 72, Week 96 |
| Main: Change from baseline of markers in insulin sensitivity and glycemic control | Change from baseline in HbA1c (%), C-peptide (ug/L), adiponectin (mg/L), insulin (mIU/L), and HOMA-IR | Week 36, Week 48, Week 72, Week 96 |
| Main: Change from baseline in body weight | Change from baseline in body weight (kg) | Week 36, Week 48, Week 96 |
| Main: To assess the immunogenicity of EFX | Detect and measure ADA, including NAb, against EFX | Through Week 96 |
| Main: To assess the safety and tolerability of EFX | Safety and tolerability will be assessed through the reporting of AEs, clinical laboratory tests, ECGs, ultrasounds, vital sign assessments, and concomitant medication usage | Through Week 96 |
| Cohort D: To assess the safety and tolerability of EFX compared to placebo when added to an existing GLP-1R agonist in subjects with type 2 diabetes and liver fibrosis due to NASH | Safety and tolerability will be assessed through the reporting of AEs, clinical laboratory assessments, ECGs, ultrasounds, vital sign assessments, and concomitant medication usage | Through Week 12 |
| Glendale |
| Arizona |
| 85306 |
| United States |
| Akero Clinical Study Site | Tucson | Arizona | 85711 | United States |
| Akero Clinical Study Site | Tucson | Arizona | 85712 | United States |
| Akero Clinical Study Site | North Little Rock | Arkansas | 72117 | United States |
| Akero Clinical Study Site | Fresno | California | 93720 | United States |
| Akero Clinical Study Site | Long Beach | California | 90808 | United States |
| Akero Clinical Study Site | Los Angeles | California | 90036 | United States |
| Akero Clinical Study Site | Pasadena | California | 91105 | United States |
| Akero Clinical Study Site | Englewood | Colorado | 80113 | United States |
| Akero Clinical Study Site | Clearwater | Florida | 33761 | United States |
| Akero Clinical Study Site | Fort Myers | Florida | 33907 | United States |
| Akero Clinical Study Site | Fort Myers | Florida | 33912 | United States |
| Akero Clinical Study Site | Hialeah Gardens | Florida | 33016 | United States |
| Akero Clinical Study Site | Lakewood Rch | Florida | 34211 | United States |
| Akero Clinical Study Site | Miami Lakes | Florida | 33016 | United States |
| Akero Clinical Study Site | Ocala | Florida | 34471 | United States |
| Akero Clinical Study Site | Sarasota | Florida | 34240 | United States |
| Akero Clinical Study Site | South Bend | Indiana | 46635 | United States |
| Akero Clinical Study Site | Topeka | Kansas | 66606 | United States |
| Akero Clinical Study Site | Bastrop | Louisiana | 71220 | United States |
| Akero Clinical Study Site | Marrero | Louisiana | 70072 | United States |
| Akero Clinical Study Site | Las Vegas | Nevada | 89109 | United States |
| Akero Clinical Study Site | Concord | North Carolina | 28027 | United States |
| Akero Clinical Study Site | Fayetteville | North Carolina | 28304 | United States |
| Akero Clinical Study Site | Morehead City | North Carolina | 28557 | United States |
| Akero Clinical Study Site | Springboro | Ohio | 45066 | United States |
| Akero Clinical Study Site | Westlake | Ohio | 44145 | United States |
| Akero Clinical Study Site | Greenville | South Carolina | 29605 | United States |
| Akero Clinical Study Site | Greenwood | South Carolina | 29646 | United States |
| Akero Clinical Study Site | Summerville | South Carolina | 29485 | United States |
| Akero Clinical Study Site | Nashville | Tennessee | 37211 | United States |
| Akero Clinical Study Site | Austin | Texas | 78746 | United States |
| Akero Clinical Study Site | Dallas | Texas | 75246 | United States |
| Akero Clinical Study Site | Edinburg | Texas | 78504 | United States |
| Akero Clinical Study Site | Edinburg | Texas | 78539 | United States |
| Akero Clinical Study Site | Fort Worth | Texas | 75044 | United States |
| Akero Clinical Study Site | Fort Worth | Texas | 76104 | United States |
| Akero Clinical Study Site | Houston | Texas | 77030 | United States |
| Akero Clinical Study Site | Houston | Texas | 77079 | United States |
| Akero Clinical Study Site | San Antonio | Texas | 78215 | United States |
| Akero Clinical Study Site | Waco | Texas | 76710 | United States |
| Akero Clinical Study Site | Webster | Texas | 77598 | United States |
| Akero Clinical Study Site | Wichita Falls | Texas | 76301 | United States |
| Akero Clinical Study Site | Ogden | Utah | 84405 | United States |
| Akero Clinical Study Site | Richmond | Virginia | 23298 | United States |
| Akero Clinical Study Site | Mexico City | Mexico |
| Akero Clinical Study Site | Monterrey | Mexico |
| Akero Clinical Study Site | San Juan | 00927 | Puerto Rico |
| 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. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 12, 2025 | Jan 2, 2026 | 14 | ||
| May 13, 2026 | Jun 8, 2026 | 15 | ||
| Jun 23, 2026 |
| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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