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A Study Evaluating the Efficacy and Safety of Pegozafermin in Participants With MASH and Fibrosis (ENLIGHTEN-fibrosis)
EU CTIS ID: 2023-509912-27-00
What this study is testing
At interim analysis: To evaluate the effect of pegozafermin compared to placebo on liver histology at 52 weeks relative to baseline biopsy. At study completion: To evaluate the effect of pegozafermin compared to placebo in reducing the risk of clinical outcome composite endpoint.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1_Males or non-pregnant females aged between 18 and 80 years (inclusive) at time of signing the informed consent form (ICF)
- 2_Biopsy-confirmed MASH, either within 6 months of screening visit [with additional requirements] or obtained during screening period in: a_ Group A: Subjects with fibrosis stage F2 or F3 per NASH CRN System and NAS >=4, with a score of at least 1 in each of steatosis, ballooning degeneration, and lobular inflammation b_ Group B: Subjects who do not meet NAS criteria for Group A and have F3 fibrosis and a score of at least 1 in steatosis and at least 1 in lobular inflammation. This will include subjects with NAS <4 and/or a ballooning degradation score of 0.
- 3_Body mass index (BMI) at Screening ≥25.0 kg/m2 (≥23 kg/m2 for Asian countries)
You likely can't join if
- 1_Chronic liver diseases other than MASH/NASH
- 2_Evidence of cirrhosis
- 3_Have type 1 diabetes or poorly controlled type 2 diabetes
- 4_Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >=250 U/L
The study team makes the final eligibility decision.
Where it's taking place
- Argentina
- India
- Hong Kong
- United States
- Korea, Republic of
- Singapore
- Japan
- Taiwan
- Canada
- Australia
- Israel
- China
- Mexico
- United Kingdom
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 - 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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Argentina; India; Hong Kong; United States; Korea, Republic of; Singapore and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.