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    Pegozafermin

    Modality: FGF21 analog

    Disease State: MASH with fibrosis (F2, F3) or MASH with compensated cirrhosis (F4)

    Summary

    Pegozafermin is an FGF21 analog currently in late-stage development for MASH in patients with moderate and severe fibrosis (F2 and F3 stages) and patients with cirrhosis (F4 stage).1

    Clinical Trials

    Severe Hypertriglyceridemia
    Phase Enrollment Status Title
    Phase III Active, not recruiting A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects With Severe Hypertriglyceridemia (SHTG) View Details
    Metabolic Dysfunction-Associated Steatohepatitis (MASH)
    Phase Enrollment Status Title
    Phase III Recruiting A Phase 3 Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects With Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis View Details
    Phase III Recruiting A Phase 3 Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects With Compensated Cirrhosis Due to Metabolic Dysfunction-Associated Steatohepatitis (MASH) View Details

    Proposed Mechanism of Action

    FGF21 Acts Via an FGF Receptor (FGFR) and the Coreceptor KLB2-6

    • Pegozafermin is an engineered fibroblast growth factor 21 (FGF21) analog designed with proprietary GlycoPEGylation to have a prolonged half-life (55-100 hours).7
    • Mechanistically, pegozafermin is hypothesized to work by binding to and activating the FGF receptors 1c, 2c, and 3c in conjunction with the beta-klotho coreceptor.3,7
    • This balanced receptor activation drives metabolic changes across multiple organs, including the liver and adipose tissue.7
    1. Roche. Product Development Pipeline. January 29, 2026. Accessed February 12, 2026.
    2. Agrawal A, Parlee S, Perez-Tilve D, et al. Molecular elements in FGF19 and FGF21 defining KLB/FGFR activity and specificity. Mol Metab. 2018;13:45-55. doi:10.1016/​j.molmet.2018.05.003
    3. Sonoda J, Chen MZ, Baruch A. FGF21-receptor agonists: an emerging therapeutic class for obesity-related diseases. Horm Mol Biol Clin Investig. 2017;30(2):20170002. doi:10.1515/​hmbci-2017-0002
    4. Kwok KHM, Lam KSL. Fibroblast Growth Factor 21 Mimetics for Treating Atherosclerosis. Endocrinol Metab (Seoul). 2017;32(2):145-151. doi:10.3803/​EnM.2017.32.2.145
    5. Yang C, Jin C, Li X, Wang F, McKeehan WL, Luo Y. Differential specificity of endocrine FGF19 and FGF21 to FGFR1 and FGFR4 in complex with KLB. PLoS One. 2012;7(3):e33870. doi:10.1371/​journal.pone.0033870
    6. Kilkenny DM, Rocheleau JV. The FGF21 Receptor Signaling Complex: Klothoβ, FGFR1c, and Other Regulatory Interactions. Vitam Horm. 2016;101:17-58. doi:10.1016/​bs.vh.2016.02.008
    7. Bailey NN, Peterson SJ, Parikh MA, Jackson KA, Frishman WH. Pegozafermin Is a Potential Master Therapeutic Regulator in Metabolic Disorders: A Review. Cardiol Rev. 2025;33(5):402-406. doi:10.1097/​CRD.0000000000000625

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    TOP

    • FGF21
      fibroblast growth factor 21

    • MASH
      Metabolic Dysfunction-Associated Steatohepatitis

    • SHTG
      Severe Hypertriglyceridemia