Metabolic Dysfunction-Associated Steatohepatitis (MASH) / Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis study: Pegozafermin
Official title A Study to Evaluate the Efficacy and Safety of Pegozafermin in Participants With Compensated Cirrhosis Due to MASH
ClinicalTrials.gov ID: NCT06419374
What this study is testing
What is Pegozafermin?
Pegozafermin is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for metabolic dysfunction-associated steatohepatitis (mash) / nonalcoholic steatohepatitis (nash) with compensated cirrhosis.
Also referred to as BIO89-100, RO7948410.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to find out whether pegozafermin works and is safe for people with advanced liver scarring from MASH.
- Who it's for
- Adults who have biopsy‑confirmed stage F4 MASH with compensated cirrhosis.
- What's involved
- Participants will receive pegozafermin and attend scheduled clinic visits for safety checks and lab tests.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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
You likely can't join if
- 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) ≥250 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Birmingham, Alabama, United States
- Homewood, Alabama, United States
- Chandler, Arizona, United States
- Peoria, Arizona, United States
- Phoenix, Arizona, United States
- Sun City, Arizona, United States
- Tucson, Arizona, United States
- Little Rock, Arkansas, United States
- North Little Rock, Arkansas, United States
- Camarillo, California, United States
- Canoga Park, California, United States
- Coronado, California, United States
- Fountain Valley, California, United States
- Fresno, California, United States
- La Jolla, California, United States
- Los Angeles, California, United States
- Pasadena, California, United States
- Poway, California, United States
- Redwood City, California, United States
- Rialto, California, United States
+ 225 more site(s).
Compensation & support
A stipend or payment for your time may be offered.
No amount is published here because ClinicalTrials.gov has no reliable field for payment or travel support. Ask the study team what's actually covered (payment for your time, travel, parking, or other study costs), and never join a trial for the compensation alone.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team, so confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Birmingham, Alabama, United States; Homewood, Alabama, United States; Chandler, Arizona, United States; Peoria, Arizona, United States; Phoenix, Arizona, United States; Sun City, Arizona, United States and 239 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.