efruxifermin (AKR-001) / Amgen, Novo Nordisk - LARVOL DELTA

Efruxifermin Improved Liver Disease and Insulin Sensitivity in Participants with Type 2 Diabetes and Metabolic Dysfunction–Associated Steatohepatitis (MASH) Cirrhosis in the SYMMETRY Trial (ADA 2026) - "Available on Friday, May 29, 2026 at 12:00am CDT."

Diabetes • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Type 2 Diabetes Mellitus

Clinical and metabolic benefits of efruxifermin in MASH: a GRADE-assessed meta-analysis of randomized trials with trial sequential analysis. (PubMed, Hepatol Int) - "Efruxifermin may produce meaningful histologic and biomarker improvements in MASH, but tolerability may limit persistence. Larger phase III RCTs with longer follow-up are needed to confirm durability, clarify effects in cirrhosis, and better define safety."

Journal • Retrospective data • Review • Fibrosis • Gastroenterology • Hepatology • Immunology • Liver Cirrhosis • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • FGF21

Hepatoprotective effects of Efruxifermin in the CDAA-HFD mouse model of advanced MASH with progressive fibrosis (EASL 2026) - No abstract available

Metastases • Preclinical • Fibrosis • Immunology • Metabolic Dysfunction-Associated Steatohepatitis

Efruxifermin ameliorates palmitate-induced hepatocyte lipotoxicity (EASL 2026) - No abstract available

Metabolic Dysfunction-Associated Steatotic Liver Disease

Study design, rationale, and baseline characteristics of the SYNCHRONY real-world trial: a phase 3 trial evaluating efruxifermin in participants non-invasively diagnosed with MASLD or MASH (EASL 2026) - No abstract available

Clinical • Non-invasive • P3 data • Real-world • Real-world evidence • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease

Efruxifermin improved digital pathology and noninvasive fibrosis measures in participants with MASH and advanced fibrosis or compensated cirrhosis: analysis of the HARMONY and SYMMETRY phase 2b trials (EASL 2026) - No abstract available

Metastases • Non-invasive • P2b data • Fibrosis • Hepatology • Immunology • Metabolic Dysfunction-Associated Steatohepatitis

Metabolic Dysfunction-Associated Steatohepatitis (MASH)-Cirrhosis Clinical Trials: Lessons Learned and Future Directions. (PubMed, Drugs) - "Levers to increase regression include an upper limit for liver stiffness measurement(LSM), a platelet threshold (> 110,000/µL), limiting CSPH, and prespecified proportions with FIB‑4 > 3.5 or enhanced liver fibrosis (ELF) > 11.3. Ongoing studies include but are not limited to survodutide, a glucagon/GLP-1 receptor dual agonist targeting metabolic drivers, efruxifermin, an FGF21 analog, and a conditionally approved drug resmetirom, which is a selective thyroid hormone receptor β agonist."

Journal • Review • Cardiovascular • CNS Disorders • Fibrosis • Gastroenterology • Hematological Disorders • Hepatic Encephalopathy • Hepatocellular Cancer • Hepatology • Hypertension • Immunology • Liver Cirrhosis • Liver Failure • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Oncology • Portal Hypertension • Solid Tumor • Transplantation • FGF21

Efficacy and Safety of Efruxifermin in Patients With MASH: A Meta-Analysis of Randomized Controlled Trials. (PubMed, Gastroenterol Hepatol (N Y)) - No abstract available

Journal • Retrospective data • Metabolic Dysfunction-Associated Steatohepatitis

Network Meta-Analysis: Comparison of Pharmacological Therapies in Compensated Metabolic Dysfunction-Associated Steatohepatitis Cirrhosis for Fibrosis Regression and MASH Resolution. (PubMed, Aliment Pharmacol Ther) - "This network meta-analysis provides relative rank-order estimates of the histological efficacy of available pharmacological therapies for compensated MASH cirrhosis. These data may have implications for the design of future clinical trials."

Journal • Retrospective data • Review • Fibrosis • Hepatitis C • Hepatology • Immunology • Liver Cirrhosis • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis

Efficacy and safety of fibroblast growth factor 21 analogs in metabolic dysfunction-associated steatotic liver disease and metabolic dysfunction-associated steatohepatitis: A systematic review and network meta-analysis. (PubMed, J Pharmacol Exp Ther) - "Among them, 284 received efruxifermin, 263 received pegbelfermin, 151 received pegozafermin, 65 received efimosfermin, 139 received MK-3655, and 375 received a placebo. SIGNIFICANCE STATEMENT: This meta-analysis evaluates the efficacy of fibroblast growth factor 21 analogs in improving metabolic dysfunction-associated steatotic liver disease. Efruxifermin and pegozafermin were the most significant in improving liver fibrosis; moreover; significant improvements in some metabolic parameters were observed with efimosfermin α, efruxifermin, and pegozafermin."

Journal • Retrospective data • Dyslipidemia • Fibrosis • Hepatology • Immunology • Liver Cirrhosis • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease • FGF21

Disease-modifying effect of efruxifermin in compensated cirrhosis due to MASH: To miss the forest for the tree(s). (PubMed, JHEP Rep) - No abstract available

Journal • Cardiovascular • Fibrosis • Hepatology • Hypertension • Immunology • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease • Portal Hypertension

Efruxifermin: “Statistically Significant Reduction in LSM with Efruxifermin at Week 96”; Metabolic dysfunction-associated steatohepatitis (Akero) - AASLD 2025

P2b data • Metabolic Dysfunction-Associated Steatohepatitis

Untapped potential of efruxifermin in lean MASH. (PubMed, Hepatol Int) - No abstract available

Journal • Metabolic Dysfunction-Associated Steatohepatitis

Efruxifermin: “In the SYMMETRY trial that enrolled participants with MASH and compensated cirrhosis (F4c), efruxifermin improved fibrosis by histology at Week 96”; Metabolic dysfunction-associated steatohepatitis (Akero) - AASLD 2025

P2b data • Metabolic Dysfunction-Associated Steatohepatitis

Novo Nordisk has completed its acquisition of Akero Therapeutics (GlobeNewswire) - "With the completion of the transaction, Novo Nordisk has acquired all outstanding shares of common stock and common stock equivalents of Akero for 54 USD per share in cash (or aggregated value of 4.7 billion USD) and a non-transferable Contingent Value Right ('CVR'). Each CVR entitles its holder to an additional payment of 6 USD per share in cash (or aggregated value of 0.5 billion USD) upon US regulatory approval of Akero’s lead candidate EFX for the treatment of compensated cirrhosis due to MASH."

M&A • Metabolic Dysfunction-Associated Steatohepatitis

Akero Therapeutics Presents New Analyses from Phase 2b SYMMETRY and HARMONY Trials of Efruxifermin at 76th Annual AASLD The Liver Meeting 2025 (GlobeNewswire) - "New post-hoc analyses of 96-week data from the SYMMETRY trial reinforce the antifibrotic activity of efruxifermin in F4c MASH: Efruxifermin was associated with statistically significant improvements in clinically significant portal hypertension (CSPH) risk, as assessed by Baveno criteria. CSPH, a serious complication of cirrhosis, increases risk of hepatic complications; Significantly more participants treated with efruxifermin vs. placebo met thresholds for clinically meaningful improvements in noninvasive measures of fibrosis that predict reduced risk of liver-related events....Additionally, an AI-powered digital pathology analysis (PathAI) of liver biopsies from the 96-week HARMONY trial in participants with F2/F3 MASH corroborated the previously reported fibrosis improvements shown by conventional pathology, providing further support for the improvements in fibrosis and MASH observed with efruxifermin."

P2b data • Metabolic Dysfunction-Associated Steatohepatitis

Role of FGF21 in Heart Failure: Molecular Insights and Therapeutic Implications. (PubMed, Cardiol Rev) - "Experimental models show that FGF21 protects against pressure overload, ischemia-reperfusion injury, doxorubicin cardiotoxicity, and diabetic cardiomyopathy by enhancing oxidative metabolism and autophagy, suppressing inflammation, boosting antioxidant defenses, and reducing fibrosis. In humans, circulating FGF21 levels are elevated across HF phenotypes and correlate with N-terminal pro-B-type natriuretic peptide, inflammatory cytokines, adverse remodeling, and poor prognosis, suggesting compensatory upregulation in the context of "FGF21 resistance." Long-acting FGF21 analogs developed for metabolic diseases, such as pegozafermin and efruxifermin, improve triglycerides, insulin sensitivity, and ectopic fat, highlighting potential cardiovascular benefit...This review integrates molecular, preclinical, and clinical evidence to position FGF21 as both a marker and a therapeutic target in HF. It aims to focus on mechanisms of action, evaluate its prognostic value,..."

Journal • Cachexia • Cardiomyopathy • Cardiovascular • Congestive Heart Failure • Fibrosis • Heart Failure • Immunology • Inflammation • Metabolic Disorders • Osteoporosis • Reperfusion Injury • FGF21 • FGFR1 • FGFR4

Safety and Efficacy of Efruxifermin in Patients With Non-Alcoholic Steatohepatitis: A Meta-Analysis of Randomized Controlled Trials (ACG 2025) - "Three randomized controlled trials (RCTs) were included. Efruxifermin compared to placebo showed a significant improvement in liver fibrosis (≥1 stages) and no worsening of NASH at doses of 28 mg (RR = 22.5; 95% CI: 3.19, 158.72) and 50 mg (RR = 18.22; 95% CI: 3.44, 96.56). Improvement in liver fibrosis (≥1 stage) and resolution of NASH were observed at 28 mg (RR = 6.39; 95% CI: 1.78, 23.01) and 50 mg (RR = 7.49; 95% CI: 2.29, 24.57)."

Retrospective data • Fibrosis • Hepatology • Immunology • Liver Cirrhosis • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease

Efficacy and Safety of Efruxifermin in Patients With MASH: A Meta-Analysis of Randomized Controlled Trials (ACG 2025) - "Four randomized controlled trials comprising 419 patients were included, with 284 patients receiving efruxifermin and 135 receiving placebo. Efruxifermin significantly increased the likelihood of MASH resolution without worsening (RR = 2.42; 95% CI: 1.48–3.94; p < 0.001), ≥1-stage fibrosis improvement without MASH worsening (RR = 1.83; 95% CI: 1.17–2.84; p = 0.01). It also led to significant improvements in MASH resolution and improvement (RR = 3.77; 95% CI: 1.10–12.87; p = 0.03)."

Retrospective data • Fibrosis • Hepatology • Immunology • Inflammation • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • FGF21

Harnessing FGF21: A Meta-Analytic Evaluation of Efruxifermin's Efficacy and Safety in Non-Alcoholic Steatohepatitis (ACG 2025) - "Five RCTs encompassing various stages of NASH (F1–F4 fibrosis) were analyzed. The pooled analysis demonstrated that EFX significantly improved liver histology and metabolic parameters compared to placebo. Specifically, the relative risk (RR) for achieving ≥1-stage fibrosis improvement without NASH worsening was 1.87 (95% CI: 1.15 to 2.92; I² = 45%), indicating a substantial benefit of EFX over placebo."

Clinical • Fibrosis • Hepatology • Immunology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • FGF21

FGF19/FGF21 Analogues in NASH: Systematic Review (ACG 2025) - "We found eight trials of FGF21 analogues (Efruxifermin, Pegozafermin and Pegbelfermin) and two of the FGF19 analogue Aldafermin. Efruxifermin produced significant benefits: in the 24-week HARMONY trial (n=128, F2–F3 fibrosis), 39% of efruxifermin treated patients had ≥1 stage fibrosis improvement (no NASH worsening) vs 20% on placebo. In the 16-week BALANCED trial (F1–F3), efruxifermin decreased hepatic fat fraction on average by 13.26% vs 0.3% with placebo."

Review • Fibrosis • Hepatology • Immunology • Inflammation • Liver Cirrhosis • Liver Failure • Metabolic Dysfunction-Associated Steatohepatitis • FGF19 • FGF21

Safety and efficacy of 24 weeks of pemvidutide in metabolic dysfunction-associated steatotic liver disease: A randomized, controlled clinical trial. (PubMed, JHEP Rep) - P1 | "The current trial demonstrates that continued treatment with pemvidutide further improves these clinical markers of MASH. The study is registered at ClinicalTrials.gov (NCT05292911)."

Clinical • Journal • Diabetes • Genetic Disorders • Hepatology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease • Obesity • Type 2 Diabetes Mellitus

COMBINATION THERAPY IN METABOLIC DYSFUNCTION-ASSOCIATED STEATOHEPATITIS: GLP-1R AGONIST WITH OTHERS (AASLD 2025) - "This study evaluates the efficacy of GLP-1 receptor agonists, specifically Semaglutide, in combination with other agents such as MGL3196, GFT505, Efruxifermin, and Retatrutide in a murine MASH model. The findings indicate that combination therapies involving GLP-1 receptor agonists, particularly Semaglutide, with other pharmacological agents hold promise in the treatment of MASH, offering a potential strategy to address the complex pathophysiology of MASH."

Combination therapy • Fibrosis • Hepatology • Immunology • Inflammation • Liver Cirrhosis • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis

Akero Therapeutics, Inc…announced two upcoming oral presentations and a poster presentation at the 76th Annual American Association for the Study of Liver Diseases (AASLD) The Liver Meeting 2025 taking place November 7-11, 2025, in Washington, DC. (GlobeNewswire) - "The presentations will highlight findings from the 96-week Phase 2b SYMMETRY study evaluating the safety and efficacy of lead product candidate efruxifermin (EFX) in patients with compensated cirrhosis (F4c) due to metabolic dysfunction-associated steatohepatitis (MASH), along with insights from an AI-powered digital analysis of histology data from the 96-week Phase 2b HARMONY study in patients with pre-cirrhotic (F2-F3) MASH."

P2b data • Metabolic Dysfunction-Associated Steatotic Liver Disease

Novo Nordisk to acquire Akero Therapeutics and its promising phase 3 FGF21 analogue to expand MASH portfolio (GlobeNewswire) - "Akero’s fibroblast growth factor 21 (FGF21) analogue efruxifermin (EFX) is a potentially best-in-class treatment for metabolic dysfunction-associated steatohepatitis (MASH)....Under the terms of the agreement, Novo Nordisk will acquire all outstanding shares of Akero’s common stock at a price of 54 USD per share in cash (or aggregated value of 4.7 billion USD) at closing."

M&A • Liver Cirrhosis • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease