Pegozafermin for Liver Cirrhosis

Recruiting in Palo Alto (17 mi)

+146 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: 89bio, Inc.

Disqualifiers: Liver disorder, Hepatic decompensation, Hepatocellular carcinoma, Diabetes, others

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The study will assess the efficacy and safety of pegozafermin administered in participants with compensated cirrhosis due to MASH (biopsy-confirmed fibrosis stage F4 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 joining the trial.

Research Team

Maya Margalit, MD

Principal Investigator

89bio, Inc.

Eligibility Criteria

Adults aged 18-75 with compensated cirrhosis due to MASH, confirmed by a liver biopsy showing stage F4 fibrosis. Participants must have a BMI of ≥25 (≥23 for Asians) and <50 kg/m² and at least one metabolic risk factor. Pregnant individuals or those not meeting the specific criteria are excluded.

Inclusion Criteria

I have severe liver scarring confirmed by a biopsy.

Body mass index (BMI) at screening ≥25.0 (≥23.0 for Asian participants) and <50.0 kg/m^2

At least 1 metabolic risk factor

Exclusion Criteria

My liver condition is not MASH.

My liver is not working properly.

I have or had liver cancer.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive pegozafermin or placebo for the duration of the study

24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Pegozafermin (Growth Factor)

Trial Overview The trial is testing Pegozafermin's effectiveness and safety against a placebo in treating compensated cirrhosis caused by MASH. It involves administering Pegozafermin to see if it improves liver health compared to no active treatment.

Participant Groups

Group I: Pegozafermin Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Matched placebo

Who Is Running the Clinical Trial?

89bio, Inc.

Lead Sponsor

Trials

7

Recruited

2,600+