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June 24, 2023New England Journal of Medicine492 citationsOpen Access

Randomized, Controlled Trial of the FGF21 Analogue Pegozafermin in NASH

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RLRohit LoombaASArun J. SanyalKKKris V. Kowdley

Key Points

  • To assess the efficacy and safety of the FGF21 analogue pegozafermin in patients with nonalcoholic steatohepatitis (NASH).
  • Conducted a randomized, controlled phase 2b clinical trial (ENLIVEN; ClinicalTrials.gov number, NCT04929483) evaluating pegozafermin treatment.
  • Treatment with pegozafermin resulted in improvements in fibrosis (numerical event rates, effect sizes, and p-values not reported in abstract).
  • The observed therapeutic improvements support advancing pegozafermin into phase 3 clinical evaluation.

Abstract

In this phase 2b trial, treatment with pegozafermin led to improvements in fibrosis. These results support the advancement of pegozafermin into phase 3 development. (Funded by 89bio; ENLIVEN ClinicalTrials.gov number, NCT04929483.).

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Cite This Study

Loomba et al. (2023) studied this question.

synapsesocial.com/papers/69699d38e0e11f4d2ddfd7fahttps://doi.org/10.1056/nejmoa2304286
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Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1The FGF21 analog pegozafermin in severe hypertriglyceridemia: a randomized phase 2 trial2023 · 118 citations
  2. 2Safety and efficacy of FGF21 analogs in nonalcoholic steatohepatitis: a meta-analysis of randomized clinical trials2024
  3. 3Current and future pharmacological therapies for NAFLD/NASH2017 · 670 citations
  4. 4Safety 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 Study2024 · 95 citations
  5. 5A unimolecular GLP-1 and FGF21 dual agonist for treatment of metabolic dysfunction-associated steatohepatitis2025