A Study Evaluating the Efficacy and Safety of Pegozafermin in Participants With MASH and Fibrosis (ENLIGHTEN-Fibrosis)

Condition(s) studied

Investigational drug(s) / intervention(s)

Pegozafermin: Subcutaneous injection

Placebo: Subcutaneous injection

Study summary

The study will assess the efficacy and safety of 2 dose regimens of pegozafermin compared to placebo for the treatment of liver fibrosis stage F2 or F3 in adult participants with MASH.

Eligibility

Primary outcome measure(s)

• Number of Participants With at Least an Improvement of Fibrosis ≥1 Stage Without Worsening of Steatohepatitis at Week 52 — Week 52
  Worsening of steatohepatitis is defined as increase in non-alcoholic fatty liver disease (NAFLD) Activity Score (NAS) for ballooning, inflammation, or steatosis
• Number of Participants With Resolution of Steatohepatitis Without Worsening of Fibrosis at Week 52 — Week 52
  Resolution of steatohepatitis is defined as total absence of ballooning (score=0) and absent or mild inflammation (score 0 to 1). Worsening of fibrosis is defined as progression of fibrosis by ≥1 stage.
• Time to First Occurrence of Disease Progression — Up to 5 years
  Final analysis of the time to first occurrence of disease progression will be measured by a composite of protocol-specified clinical events

Trial sites (370)

+ 330 more sites — see the full list on the official registry below.