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Cited by 523Liver Disease Diagnosis and TreatmentFibroblast Growth Factor ResearchLiver physiology and pathology

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Randomized, Controlled Trial of the FGF21 Analogue Pegozafermin in NASH

Open access
Loomba, Rohit, Sanyal, Arun J., Kowdley, Kris V., Bhatt, Deepak L., Alkhouri, Naim, Frias, Juan P., Bedossa, Pierre, Harrison, Stephen A., Lazas, Donald, Barish, Robert, Gottwald, Mildred D., Feng, Shibao, Agollah, Germaine D., Hartsfield, Cynthia L., Mansbach, Hank, Margalit, Maya, Abdelmalek, Manal F.·2023·New England Journal of Medicine
DOI 10.1056/nejmoa2304286PMC PMC10718287
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Abstract

BACKGROUND: Pegozafermin is a long-acting glycopegylated (pegylated with the use of site-specific glycosyltransferases) fibroblast growth factor 21 (FGF21) analogue in development for the treatment of nonalcoholic steatohepatitis (NASH) and severe hypertriglyceridemia. The efficacy and safety of pegozafermin in patients with biopsy-proven noncirrhotic NASH are not well established. METHODS: In this phase 2b, multicenter, double-blind, 24-week, randomized, placebo-controlled trial, we randomly assigned patients with biopsy-confirmed NASH and stage F2 or F3 (moderate or severe) fibrosis to receive subcutaneous pegozafermin at a dose of 15 mg or 30 mg weekly or 44 mg once every 2 weeks or placebo weekly or every 2 weeks. The two primary end points were an improvement in fibrosis (defined as reduction by ≥1 stage, on a scale from 0 to 4, with higher stages indicating greater severity), with no worsening of NASH, at 24 weeks and NASH resolution without worsening of fibrosis at 24 weeks. Safety was also assessed. RESULTS: Among the 222 patients who underwent randomization, 219 received pegozafermin or placebo. The percentage of patients who met the criteria for fibrosis improvement was 7% in the pooled placebo group, 22% in the 15-mg pegozafermin group (difference vs. placebo, 14 percentage points; 95% confidence interval [CI], -9 to 38), 26% in the 30-mg pegozafermin group (difference, 19 percentage points; 95% CI, 5 to 32; P = 0.009), and 27% in the 44-mg pegozafermin group (difference, 20 percentage points; 95% CI, 5 to 35; P = 0.008). The percentage of patients who met the criteria for NASH resolution was 2% in the placebo group, 37% in the 15-mg pegozafermin group (difference vs. placebo, 35 percentage points; 95% CI, 10 to 59), 23% in the 30-mg pegozafermin group (difference, 21 percentage points; 95% CI, 9 to 33), and 26% in the 44-mg pegozafermin group (difference, 24 percentage points; 95% CI, 10 to 37). The most common adverse events associated with pegozafermin therapy were nausea and diarrhea. CONCLUSIONS: 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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Research works printed but not linked: 2

  1. Loomba R, Mansbach H, Tseng L, et al. BIO-89-100, a glycoPEGylated FGF21 analogue, demonstrates robust reduction in serum lipids and long half-life in a phase 1 randomized, controlled single ascending dose trial in healthy subjects. Hepatology 2019;70:1266A-1266A. abstract.
  2. Sanyal AJ, Loomba R, Anstee QM, et al. Minimizing variability and increasing concordance for NASH histological scoring in NASH clinical trials. Hepatology 2021;74:968A-968A. abstract.

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Metadata

Authors
Loomba, R., Sanyal, A. J., Kowdley, K. V., Bhatt, D. L., Alkhouri, N., Frias, J. P., Bedossa, P., Harrison, S. A., Lazas, D., Barish, R., Gottwald, M. D., Feng, S., Agollah, G. D., Hartsfield, C. L., Mansbach, H., Margalit, M., & Abdelmalek, M. F.
Affiliations
  • Mount Sinai Health System (US)
  • From the NAFLD Research Center, Division of Gastroenterology and Hepatology, Department of Medicine, University of California, San Diego, La Jolla (R.L.), Velocity Clinical Research, Los Angeles (J.P.F.), and 89bio, San Francisco (M.D.G., S.F., G.D.A., C.L.H., H.M.); the Division of Gastroenterology, Hepatology, and Nutrition, Virginia Commonwealth University, Richmond (A.J.S.); Liver Institute Northwest, Seattle (K.V.K.); Mount Sinai Heart, Icahn School of Medicine at Mount Sinai Health System, New York (D.L.B.); Arizona Liver Health, Chandler (N.A.); Liverpat, Paris (P.B.); Radcliffe Department of Medicine, University of Oxford, Oxford, United Kingdom (S.A.H.); Pinnacle Clinical Research, San Antonio, TX (S.A.H.); ObjectiveHealth–Digestive Health Research, Nashville (D.L.); Ocala GI Research, Ocala, FL (R.B.); 89bio, Rehovot, Israel (M.M.); and the Division of Hepatobiliary Disease, Mayo Clinic, Rochester, MN (M.F.A.).
ORCID
Venue
New England Journal of Medicine
Publisher
Massachusetts Medical Society
Published
2023-09-14
Volume
389
Issue
11
Pages
998-1008
ISSN
  • 0028-4793 (ISSN-L)
  • 1533-4406
DOI
10.1056/nejmoa2304286
PMC
PMC10718287
OpenAlex
W4381884589
Cited by
522
References
29
Citations by year
2026: 162 · 2025: 197 · 2024: 137 · 2023: 26
FWCI
104.23
Type
journal article
Language
en
Open access
Licence
www.nejmgroup.org/legal/terms-of-use.htm (vor)
Locations
  • New England Journal of Medicine (publishedVersion)
  • PubMed (publishedVersion)
  • PubMed Central (acceptedVersion)
  • eScholarship (California Digital Library) (submittedVersion)
Funders
89bio
Topics
  • Health Sciences › Medicine › Hepatology › Liver Disease Diagnosis and Treatment
  • Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Fibroblast Growth Factor Research
  • Health Sciences › Medicine › Hepatology › Liver physiology and pathology
Keywords
FGF21 analogues, nonalcoholic steatohepatitis, liver fibrosis, NASH resolution, hypertriglyceridemia, drug safety, dose comparison, subcutaneous administration, noninvasive fibrosis assessment, non-invasive fibrosis scores
MeSH terms
Biopsy, Double-Blind Method, Fibroblast Growth Factors, Fibrosis, Gastrointestinal Agents, Humans, Injections, Subcutaneous, Treatment Outcome, Non-alcoholic Fatty Liver Disease

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