Patient Care brings primary care clinicians a lot of medical news every day—it’s easy to miss an important study. The Daily Dose provides a concise summary of one of the website's leading stories you may not have seen.
On June 30, 2023, we reported on a study published in the New England Journal of Medicine that evaluated the efficacy and safety of pegozafermin in patients with noncirrhotic nonalcoholic steatohepatitis (NASH).
In the phase 2b ENLIVEN trial of the investigational agent pegozafermin, researchers enrolled individuals aged 21 to 75 years with biopsy-confirmed NASH and stage F2 or F3 fibrosis. A total of 222 participants were randomly assigned to receive subcutaneous pegozafermin 15 mg or 30 mg weekly, pegozafermin 44 mg once every 2 weeks, or placebo on a weekly or biweekly basis. The enrollment period was September 2021 to August 2022.
The coprimary outcomes of interest were an improvement in fibrosis with no worsening of NASH at 24 weeks and NASH resolution without worsening of fibrosis at 24 weeks. Investigators defined an improvement in fibrosis as a reduction of 1 stage or greater and NASH resolution as total absence of ballooning and mild or no inflammation without worsening of fibrosis.
At 24 weeks the percentage of participants receiving pegozafermin with at least 1-stage fibrosis improvement without worsening NASH was higher vs placebo (7%) as follows:
Weekly 30-mg dose (26% vs 7%)
Every-2-week 44-mg dose (27% vs 7%)
Weekly 15-mg dose (22% vs 7%)
At 24 weeks the percentage of participants NASH resolution without worsening fibrosis NASH was higher vs placebo (2%) as follows:
Weekly 30-mg dose (23% vs 2%)
Every-2-week 44-mg dose (26% vs 2%)
Weekly 15-mg dose (37% vs 2%)
A note from authors
"In this phase 2b trial, pegozafermin treatment for 24 weeks led to improvements in fibrosis with both weekly and every-2-week administration in patients with biopsy-confirmed NASH. A potential for administration once every 2 weeks may increase patient convenience and adherence to treatment. Results of this trial may be informative for guiding dose selection for larger and longer phase 3 trials involving patients with NASH."