Clinical Trials Enrolment

Enrollment open Click here to contact us today.

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89bio BIO89-100-131 (Metabolic Dysfunction-Associated Steatohepatitis)

Purpose of this Study

We are doing this study to find out if an experimental drug called pegozafermin (the study drug) is a safe and effective option for people with Metabolic Dysfunction Associated Steatohepatitis (MASH).

Who Can Participate?

Eligibility

Adults ages 18-75 who:

  • Are diagnosed with MASH confirmed by liver biopsy
  • Have fibrosis stage F2 or F3
  • Have at least 2 of the following risk factors: waist circumference >37 inches for males or >32 inches for females, body mass index >25 (>23 if Asian), diagnosis of Type 2 Diabetes, hypertriglyceridemia, HDL cholesterol <40 for males or <50 for females, hypertension

Age Range

18-75

Sex/Genders

Male (cisgender)

Female (cisgender)

Non-binary or gender fluid

Transgender male

Transgender female

Contact us if you think you might qualify.

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

Brief description of study

The purpose of this study is to learn about the safety, effectiveness, and long-term outcomes of the research drug, pegozafermin, for patients with compensated cirrhosis due to MASH when compared to a placebo.

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:

    Metabolic Dysfunction-associated Steatohepatitis (MASH)

  • Age: Between 18 Year(s) - 75 Year(s)

  • Gender: Male or Female

  • Other Inclusion Criteria:

    1. Males or non-pregnant females aged between 18 and 75 years (inclusive) at the time of signing the informed consent form (ICF).
    2. Presence of at least one metabolic risk factor
    3. Evidence of both compensated cirrhosis (biopsy-confirmed fibrosis stage F4 per NASH CRN system) and MASH etiology (per modified Liver Forum Criteria as defined in protocol), either through a historical biopsy or a biopsy at Screening
    4. Body mass index (BMI) at Screening ≥25.0 (≥23.0 for Asian subjects) and <50.0 kg/m2

You may not be eligible for this study if the following are true:

    1. Chronic liver diseases other than MASH
    2. Past or current evidence of hepatic decompensation, including bleeding from gastroesophageal varices, cirrhotic ascites, or hepatic encephalopathy, spontaneous bacterial peritonitis, hepatorenal syndrome, or acute on chronic liver failure
    3. Past or current evidence of large esophageal or gastric varices, varices with “red-wale” signs, regardless of size on endoscopy
    4. Uncontrolled or newly diagnosed (≤3 months since diagnosis) type 2 diabetes
    5. Type 1 diabetes
    6. Child-Pugh Class B or C status
  • Contact us if you think you might qualify.