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
For more information, contact the study team at mike.elgasim@duke.edu.

Age Range

18-75

Sex/Genders

Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No

What is Involved?

Description

If you choose to join this study, you will get a random assignment (by chance) to 1 of 3 study groups. Depending on your assignment, you will:
  • Take a 44 mg dose of the study drug once every 2 weeks; OR
  • Take a 30 mg dose of the study drug once per week; OR
  • Take a placebo (inactive substance that has no drug in it)
The study will last about 40 months and involve 14 visits to our clinic. Study procedures at these visits will include the following:
  • Electrocardiograms
  • Blood draws
  • Questionnaires

Locations

Duke University Hospital

Visit Timing

Weekdays

Compensation

Yes

Spanish Materials Available

No

Study Details

Full Title

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

Principal Investigator

Amreen
Dinani

Protocol Number

PRO00115755

NCT ID

NCT06318169

Phase

III

Enrollment Status

Pending Open to Enrollment
ClinicalTrials.gov