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Clinical Trial ● Currently Recruiting Phase III NCT06318169

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

A Study Evaluating the Efficacy and Safety of Pegozafermin in Participants With MASH and Fibrosis (ENLIGHTEN-Fibrosis) — Recruiting • Phase III • Gastroenterology • NCT06318169.

📅 05 May 2026 ⏱ 1 min read
Currently Recruiting
This trial is actively seeking participants in the UK. Discuss eligibility with your patient before referring.
Status
Currently Recruiting
Phase
Phase III
NCT ID
NCT06318169
Sponsor
89bio, Inc.
Start
2024-03-13
ClinicaliQ Trial Snapshot
  • A Study Evaluating the Efficacy and Safety of Pegozafermin in Participants With MASH and Fibrosis (ENLIGHTEN-Fibrosis) — Recruiting • Phase III • Gastroenterology • NCT06318169.
  • What is being tested: Pegozafermin (a FGF21 analogue) at two different dose regimens versus placebo for treating liver fibrosis (stages F2–F3) in adults with metabolic dysfunction-associated steatohepatitis (MASH).
  • Patient eligibility overview: Adult participants with confirmed MASH diagnosis and fibrosis staging of F2 or F3, excluding more advanced cirrhosis (F4) and those with decompensated liver disease.
Use This Page For
  • Quick orientation before opening the registry record.
  • Checking recruitment status, phase and sponsor at a glance.
  • Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying

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 Snapshot
  • Key Inclusion Criteria: * Males or non-pregnant females aged between 18 and 80 years (inclusive) at time of signing the informed consent form (ICF) * Biopsy-confirmed MASH with fibrosis stage F2 or F3 * Body mass index (BMI) at screening ≥25.0 kilograms (kg)/meters squared (m^2) (≥23 kg/m^2 for Asian participants). Key

Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.

Full Trial Details
View this trial on the source registry
Eligibility criteria, protocol, and results when available
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