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Study to Evaluate the Efficacy and Safety of Pegozafermin in Participants With Compensated Cirrhosis Due to MASH (ENLIGHTEN-Cirrhosis)
EU CTIS ID: 2023-510395-31-00
What this study is testing
At interim analysis: To evaluate the effect of pegozafermin compared to placebo on regression of fibrosis at 24 months relative to baseline biopsy. At study completion: To evaluate the effect of pegozafermin compared to placebo in reducing the risk of clinical outcomes measured as a 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 75 years (inclusive) at time of signing the informed consent form (ICF)
- 2_Presence of type 2 diabetes mellitus (T2DM) diagnosed at least 3 months before Screening or at least two metabolic risk factors as defined in the protocol
- 3_Biopsy-confirmed fibrosis stage F4 MASH (per non-alcoholic steatohepatitis [NASH] Clinical Research Network (CRN) system) with compensated cirrhosis
- 4_Body mass index (BMI) at Screening ≥25.0 (≥23.0 for Asian subjects) and <50.0 kg/m2
You likely can't join if
- 1_Liver disorder other than MASH
- 2_History or evidence of hepatic decompensation
- 3_History or evidence of hepatocellular carcinoma
- 4_Have type 1 diabetes mellitus or unstable type 2 diabetes mellitus
- 5_ALT or aspartate aminotransferase (AST) ≥250 units per liter (U/L)
- 6_Participants taking vitamin E (>400 international units [IU]/day) must be on stable dose for at least 6 months prior to screening and up to randomization
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- Israel
- Turkey
- United States
- Mexico
- Hong Kong
- Australia
- Korea, Republic of
- Argentina
- Taiwan
- United Kingdom
- Brazil
- Singapore
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 Canada; Israel; Turkey; United States; Mexico; Hong Kong and 7 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.