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

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Status and phase: Enrolling; Phase 3

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

Treatments: Other: Placebo; Biological: Pegozafermin

Study type: Interventional

Funder types: Industry

Identifiers

NCT06318169

BIO89-100-131

Details and patient eligibility

About

The study will assess the efficacy and safety of 2 dose regimens of pegozafermin for the treatment of liver fibrosis stage 2 or 3 in adult participants with MASH (previously known as nonalcoholic steatohepatitis [NASH]).

Enrollment: 1,050 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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 (previously named NASH) with fibrosis stage F2 or F3 per NASH clinical research network (CRN) System and NAS ≥4, with a score of at least 1 in each of steatosis, ballooning degeneration, and lobular inflammation or NAS <4 and/or a ballooning degradation score of 0 with fibrosis stage F3 and a score of at least 1 in steatosis. A historical biopsy must be within 6 months of screening visit (with additional requirements).
• Body mass index (BMI) at screening ≥25.0 kilograms (kg)/meters squared (m^2) (≥23 kg/m^2 for Asian countries)

Key Exclusion Criteria:

• Chronic liver diseases other than MASH/NASH
• Evidence of cirrhosis on screening liver biopsy
• Have type 1 diabetes or poorly controlled type 2 diabetes
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥250 units per liter (U/L)
• Participants taking vitamin E (>400 international units [IU]/day) or pioglitazone must be on stable dose for at least 6 months prior to screening

Other inclusion and exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,050 participants in 3 patient groups, including a placebo group

Pegozafermin Regimen 1

Experimental group

Treatment:

Biological: Pegozafermin

Pegozafermin Regimen 2

Experimental group

Treatment:

Biological: Pegozafermin

Placebo

Placebo Comparator group

Description:

Matched Placebo will be administered in Regimens 1 and 2.

Treatment:

Other: Placebo