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NCT Number: NCT06419374

A Study to Evaluate the Efficacy and Safety of Pegozafermin in Participants With Compensated Cirrhosis Due to MASH

The study will assess the efficacy and safety of pegozafermin administered in participants with compensated cirrhosis due to MASH (biopsy-confirmed fibrosis stage F4 MASH [previously known as nonalcoholic steatohepatitis, NASH]).

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Key information

Conditions

Metabolic Dysfunction-Associated Steatohepatitis (MASH) / Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis Digestive System Diseases Fatty Liver Fibrosis Liver Diseases Metabolic Diseases Non-alcoholic Fatty Liver Disease Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

89bio Clinical Study Site, Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • Males or non-pregnant females aged between 18 and 75 years (inclusive) at time of signing the informed consent form (ICF).
  • Participants must have type 2 diabetes mellitus diagnosed at least 3 months before screening or at least 2 metabolic risk factors.
  • Biopsy-confirmed fibrosis stage F4 MASH (NASH Clinical Research Network (CRN) system) with compensated cirrhosis.
  • Body mass index (BMI) at screening ≥25.0 (≥23.0 for Asian participants) and <50.0 kilograms (kg)/meters squared (m^2).

Key Exclusion Criteria:

  • Liver disorder other than MASH.
  • History or evidence of hepatic decompensation.
  • History or evidence of hepatocellular carcinoma.
  • Have type 1 diabetes mellitus or poorly controlled type 2 diabetes mellitus.
  • ALT or aspartate aminotransferase (AST) ≥250 units per liter (U/L).
  • Participants taking vitamin E (>400 international units [IU]/day) must be on stable dose for at least 6 months prior to screening.

Other protocol-defined inclusion and exclusion criteria may apply.

Treatment and study plan

Pegozafermin

Biological

Subcutaneous injection

Other names: BIO89-100

Placebo

Drug

Subcutaneous injection

Primary outcomes

  1. Proportion of Participants Achieving Fibrosis Regression

    Time frame: Baseline through Month 24

    Fibrosis regression is defined as improvement in fibrosis by ≥1 stage, at Month 24 biopsy relative to baseline biopsy.

  2. Time to First Occurrence of Disease Progression as Measured by Composite of Protocol -Specified Clinical Events

    Time frame: Baseline up to 5 years

Secondary outcomes

  1. Change from Baseline in Enhanced Liver Fibrosis (ELF) Score

    Time frame: Baseline, up to Month 60

  2. Change from Baseline in Alanine Aminotransferase (ALT) Level

    Time frame: Baseline, up to Month 60

  3. Change from Baseline in FibroScan Vibration-controlled Transient Elastography (VCTE)

    Time frame: Baseline, up to Month 60

  4. Proportion of Participants who Develop Clinically Significant Portal Hypertension (CSPH)

    Time frame: Baseline up to Month 60

Study contacts

Contact information is provided by the study sponsor or research team.

Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

CONTACT

Reference Study ID Number: BIO89-100-132 ENLIGHTEN clinical trial / No attachments to email below.

CONTACT

[email protected]

888-662-6728 (U.S. Only)

Sponsors and collaborators

Lead sponsor

89bio, Inc.

Industry

Registry information

Official study title

A Phase 3 Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects With Compensated Cirrhosis Due to Metabolic Dysfunction-Associated Steatohepatitis (MASH) (ENLIGHTEN-Cirrhosis)

Important dates

Study start
2024
Primary completion
2028
Study completion
2031
First posted
May 17, 2024
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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