Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH) With Fibrosis study: Pegozafermin
Official title A Study Evaluating the Efficacy and Safety of Pegozafermin in Participants With MASH and Fibrosis (ENLIGHTEN-Fibrosis)
ClinicalTrials.gov ID: NCT06318169
What this study is testing
What is Pegozafermin?
An investigational subcutaneous injectable medicine being studied as a potential treatment for Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH) with fibrosis. It is designed to activate fibroblast growth factor 21 (FGF21) pathways to improve metabolic function and reduce liver fibrosis.
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
- This study is testing whether pegozafermin can safely reduce liver scarring in people with MASH.
- Who it's for
- You may be able to join if you are an adult with MASH and liver fibrosis stage F2 or F3.
- What's involved
- You would take pegozafermin or a pretend treatment. You will have regular check‑ups to see how your liver is doing.
- Time commitment
- The study lasts several months and requires clinic visits at set times.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
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 80
You may be able to join if
- Males or non-pregnant females aged between 18 and 80 years (inclusive) at time of signing the informed consent form (ICF)
- Biopsy-confirmed MASH with fibrosis stage F2 or F3
- Body mass index (BMI) at screening ≥25.0 kilograms (kg)/meters squared (m\^2) (≥23 kg/m\^2 for Asian participants). Key
You likely can't join if
- Chronic liver diseases other than MASH
- Evidence of cirrhosis on screening liver biopsy
- Have type 1 diabetes or poorly controlled type 2 diabetes
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥250 units per liter (U/L)
- Participants taking vitamin E (\>400 international units [IU]/day) or pioglitazone 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
- Chandler, Arizona, United States
- Glendale, Arizona, United States
- Sun City, Arizona, United States
- Tucson, Arizona, United States
- Little Rock, Arkansas, United States
- North Little Rock, Arkansas, United States
- Canoga Park, California, United States
- Coronado, California, United States
- Escondido, California, United States
- Fountain Valley, California, United States
- Fresno, California, United States
- Gardena, California, United States
- La Jolla, California, United States
- Lancaster, California, United States
- Long Beach, California, United States
- Montclair, California, United States
- Orange, California, United States
- Pasadena, California, United States
- Poway, California, United States
+ 261 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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 80 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; Chandler, Arizona, United States; Glendale, Arizona, United States; Sun City, Arizona, United States; Tucson, Arizona, United States; Little Rock, Arkansas, United States and 275 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.