Pegozafermin for Fatty Liver Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
The study will assess the efficacy and safety of 2 dose regimens of pegozafermin for the treatment of liver fibrosis stage 2 or 3 in adult participants with MASH (previously known as nonalcoholic steatohepatitis \[NASH\]).
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, if you are taking vitamin E at more than 400 IU per day, you must have been on a stable dose for at least 6 months before the screening.
Is Pegozafermin safe for humans?
Pegozafermin has been studied in humans and showed improvements in metabolic markers without major safety concerns in trials for nonalcoholic steatohepatitis and severe hypertriglyceridemia. It was tested in both healthy volunteers and patients with these conditions, and no significant safety issues were reported.12345
How is the drug Pegozafermin unique for treating fatty liver disease?
What data supports the effectiveness of the drug Pegozafermin for treating fatty liver disease?
Research shows that Pegozafermin, a drug similar to a natural hormone called FGF21, has improved liver health and metabolism in both diabetic monkeys and healthy humans. In a study with patients having severe high triglycerides, Pegozafermin significantly reduced liver fat and triglyceride levels, suggesting it could be effective for fatty liver disease.12346
Who Is on the Research Team?
Millie Gottwald, PharmD
Principal Investigator
89bio, Inc.
Are You a Good Fit for This Trial?
Adults aged 18-75 with a BMI of ≥25 (≥23 for Asians) and <50, diagnosed with MASH (formerly NASH) having moderate to severe liver fibrosis are eligible. They must have had a recent biopsy confirming the disease stage and severity. Pregnant individuals or those outside the BMI range are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive pegozafermin or placebo for the treatment of liver fibrosis stage 2 or 3 in adult participants with MASH
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Pegozafermin
Find a Clinic Near You
Who Is Running the Clinical Trial?
89bio, Inc.
Lead Sponsor