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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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Rohit Loomba
Rohit LoombaPediatric Cardiology
Arun J. Sanyal
Arun J. SanyalUniversity of North Carolina at Chapel Hill
Kris V. Kowdley
Kris V. KowdleySeattle Pacific University

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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