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

Metabolic Disorder
Non Alcoholic Steato-Hepatitis
Metabolic dysfunction-associated steatohepatitis (MASH)

For Medical Professional
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Basic Details

Sponsor Hoffmann-La Roche

Phase Phase 3

Trial Identifier NCT06419374, BIO89-100-132, GC46898

Condition Metabolic Dysfunction-Associated Steatohepatitis (MASH) / Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis

Official 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)

Study Summary

The study will assess the efficacy and safety of pegozafermin administered in participants with biopsy-confirmed and clinically confirmed compensated cirrhosis due to MASH .

Eligibility Criteria

Gender

All

Age

≥18 Years & ≤ 75 Years

Healthy Volunteers

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.
Evidence of both cirrhosis and MASH etiology, either through a historical biopsy or a biopsy at Screening.
Clinical diagnosis of cirrhosis based on the NIT algorithm.

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.

This page summarises information from public registry websites, such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc. To learn more about this study, see the For Medical Professional tab or visit one of those websites.

The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

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What is Clinical Research?

In clinical research, volunteers, researchers, and medical professionals work together toward a shared goal: better treatment outcomes for patients. Clinical trials are vital to their process. They are carefully designed and follow approved protocols.

For the latest version of this information please go to www.forpatients.roche.com

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

Basic Details

Study Summary

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

What is Clinical Research?

For the latest version of this information please go to www.forpatients.roche.com

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

For the latest version of this information please go to www.forpatients.roche.com