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

Conditions

• Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH) With Fibrosis

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• Pegozafermin — BIOLOGICAL
  Subcutaneous injection
• Placebo — OTHER
  Subcutaneous injection

Study Details

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.

Key Dates

Start date

Mar 13, 2024

Status verified

Jun 2026

Primary completion

Feb 28, 2029

Completion

Feb 28, 2029

Study Design

Enrollment

1,350 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Pegozafermin Regimen 1
• Experimental: Pegozafermin Regimen 2
• Placebo Comparator: Placebo
  Matched Placebo will be administered in Regimens 1 and 2.

Primary Outcome Measure

Number of Participants With at Least an Improvement of Fibrosis ≥1 Stage Without Worsening of Steatohepatitis at Week 52 [ Time Frame: Week 52 ]

Central Contacts

• ENLIGHTEN clinical trial
  1-415-432-9270
  [email protected]

Locations (141)

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