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Tests treatment safety and results for Metabolic Dysfunction-Associated Steatohepatitis (MASH)...
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.
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 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]).
- 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.
- Biopsy-confirmed fibrosis stage F4 MASH (NASH Clinical Research Network (CRN) system) with compensated cirrhosis.
- Body mass index (BMI) at screening ≥25.0 (≥23.0 for Asian participants) and \<50.0 kilograms (kg)/meters squared (m\^2). 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. Other...
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Homewood, Alabama, United States
- Chandler, Arizona, United States
- Flagstaff, 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
- Huntington Park, California, United States
- La Jolla, California, United States
- Los Angeles, California, United States
- Pasadena, California, United States
- Poway, California, United States
+ 240 more site(s).
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
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 - 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 - 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?
Study sites include Birmingham, Alabama, United States; Homewood, Alabama, United States; Chandler, Arizona, United States; Flagstaff, Arizona, United States; Peoria, Arizona, United States; Phoenix, Arizona, United States and 254 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.