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

RecruitingPhase 3Ages 18 Years - 75 YearsAllHoffmann-La Roche
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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. * 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. 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) โ‰ฅ250 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.
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What it tests

  • Pegozafermin
  • Placebo
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Where

330 sites
89bio Clinical Study Site
Birmingham, United States
89bio Clinical Study Site
Homewood, United States
89bio Clinical Study Site
Chandler, United States
89bio Clinical Study Site
Flagstaff, United States
89bio Clinical Study Site
Peoria, United States
89bio Clinical Study Site
Phoenix, United States
89bio Clinical Study Site
Sun City, United States
89bio Clinical Study Site
Tucson, United States

โ€ฆand 322 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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