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

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.

Timeline

Start

2021-07-30

Primary completion

2023-08-25

Completion

2025-05

Outcome

Missed primary endpoint

paper In patients with compensated cirrhosis caused by MASH, efruxifermin did not significantly reduce fibrosis at 36 weeks. PMID 40341827 ↗

paper difference from placebo after adjustment for stratification factors, 3 percentage points; 95% confidence interval [CI], -11 to 17; P = 0.62 PMID 40341827 ↗

Publications

• 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Efruxifermin	Protein / enzyme biologic	28 mg	Subcutaneous
Subject	Efruxifermin	Protein / enzyme biologic	50 mg	Subcutaneous

Indications