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Phase III: Pegozafermin in Metabolic Dysfunction-Associated Steatohepatitis (MASH) with Compensated Cirrhosis (ENLIGHTEN-Cirrhosis)

Clinical Trial Overview

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)

Objective

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)

MASH: metabolic dysfunction-associated steatohepatitis
FGF21: fibroblast growth factor 21

Primary Endpoints

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.
Time to First Occurrence of Disease Progression as Measured by Composite of Protocol -Specified Clinical Events [Time Frame: Baseline up to 5 years]

Secondary Endpoints

Change from Baseline in Enhanced Liver Fibrosis Score [Time Frame: Baseline, up to Month 60]
Change from Baseline in Alanine Aminotransferase Level [Time Frame: Baseline, up to Month 60]
Change from Baseline in FibroScan Vibration-controlled Transient Elastography [Time Frame: Baseline, up to Month 60]
Proportion of Participants who Develop Clinically Significant Portal Hypertension [Time Frame: Baseline up to Month 60]

Pegozafermin

Modality: FGF21 (fibroblast growth factor 21) Analog

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Clinical Trial Overview

Inclusion and Exclusion Criteria

Enrollment and Resources

View on ClinicalTrials.gov

Inclusion and Exclusion Criteria

Key Inclusion Criteria

Key Exclusion Criteria

Males or non-pregnant females aged between 18 and 75 years (inclusive) at time of signing the informed consent form
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 system) with compensated cirrhosis
Body mass index at screening ≥25.0 (≥23.0 for Asian participants) and <50.0 kilograms (kg)/meters squared

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
Alanine aminotransferase or aspartate aminotransferase ≥250 units per liter
Participants taking vitamin E (>400 international units /day) must be on stable dose for at least 6 months prior to screening

MASH: metabolic dysfunction-associated steatohepatitis
NASH: nonalcoholic steatohepatitis

Enrollment & Resources

Enrollment

For more information on eligibility criteria, view the study or reach out to our team.

Web

ClinicalTrials.gov
Identifier: NCT06419374

Phone

1-888-662-6728
(US and Canada)

Email

[email protected]

Clinical Trial Site Locations

Clinical Trial Site Locations

For more information on recruitment status, or where the study is being conducted

Visit ClinicalTrials.gov

Information is consistent with ClinicalTrials.gov as of December 17, 2025. Products under investigation have not been approved for use outside of the clinical trial setting. This information is presented only for the purposes of providing an overview of clinical trials and should not be construed as a recommendation for use of any product for unapproved purposes.

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Call the Trial Information Support Team: 1-888-662-6728 Hours: Monday-Friday, 5am-5pm PT

MASH
metabolic dysfunction-associated steatohepatitis
FGF21
fibroblast growth factor 21
NASH
nonalcoholic steatohepatitis