Testing Pegozafermin against a placebo 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
A Phase 3 Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects With Compensated Cirrhosis Due to Metabolic Dysfunction-Associated Steatohepatitis (MASH) (ENLIGHTEN-Cirrhosis)
Interventions
Pegozafermin
Subcutaneous injection
Placebo
Subcutaneous injection
Canadian Sites (8)
89bio Clinical Study Site
Vaughan, Canada
89bio Clinical Study Site
Calgary, Alberta, Canada
89bio Clinical Study Site
Vancouver, British Columbia, Canada
89bio Clinical Study Site
Vancouver, British Columbia, Canada
89bio Clinical Study Site
Winnipeg, Manitoba, Canada
89bio Clinical Study Site
London, Ontario, Canada
89bio Clinical Study Site
Ottawa, Ontario, Canada
89bio Clinical Study Site
Toronto, Ontario, Canada
Eligibility Criteria
See who this study is looking for11 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Males or non-pregnant females aged between 18 and 75 years (inclusive) at time of signing the informed consent formInformed consentThe process of being told what taking part involves, then choosing freely.Read more → (ICF).
- +Participants must have type 2 diabetes mellitus diagnosed at least 3 months before screeningScreeningThe checks done before joining, to see whether a study fits.Read more → 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).
Exclusion
- −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 screeningScreeningThe checks done before joining, to see whether a study fits.Read more →.
- −Other protocolProtocolThe detailed plan a study must follow.Read more →-defined inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → may apply.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
What is being given or done in this study: Pegozafermin, PlaceboPlaceboA dummy treatment with no active medicine, used for comparison.Read more →.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.
There are 2 groups in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists an age range of 18 years to 75 years.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 762 people.
The study is currently expected to finish around August 2031.
The main measurement is taken over: BaselineBaselineYour starting measurements, taken before treatment begins.Read more → through Month 24.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Proportion of Participants Achieving Fibrosis Regression — measured over BaselineBaselineYour starting measurements, taken before treatment begins.Read more → through Month 24.
Time to First Occurrence of Disease Progression as Measured by Composite of ProtocolProtocolThe detailed plan a study must follow.Read more → -Specified Clinical Events — measured over Baseline up to 5 years.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06419374 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About PegozaferminBiological
Subcutaneous injection
From the trial registry — its own words, unedited.
What a biological is here: A treatment made from or by living systems — such as antibodies, vaccines, or cell-based therapies.
Read the full explanation → · in clinical review
About PlaceboDrug
Subcutaneous injection
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 18 years to 75 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 18 years to 75 years.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: BaselineBaselineYour starting measurements, taken before treatment begins.Read more → through Month 24.
The study as a whole is currently expected to finish around 2031-08.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 762 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 19 locations, including: Vaughan, Canada; Calgary, Alberta, Canada; Vancouver, British Columbia, Canada; Winnipeg, Manitoba, Canada; London, Ontario, Canada; Ottawa, Ontario, Canada, and 13 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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 \[previously known as nonalcoholic steatohepatitis, NASH\]).
Other Sites (15)
89bio Clinical Study Site
Ann Arbor, Michigan, United States
89bio Clinical Study Site
Clinton Township, Michigan, United States
89bio Clinical Study Site
Detroit, Michigan, United States
89bio Clinical Study Site
Wyoming, Michigan, United States
89bio Clinical Study Site
Ypsilanti, Michigan, United States
89bio Clinical Study Site
Minneapolis, Minnesota, United States
89bio Clinical Study Site
Rochester, Minnesota, United States
89bio Clinical Study Site
Albany, New York, United States
89bio Clinical Study Site
New York, New York, United States
89bio Clinical Study Site
New York, New York, United States
89bio Clinical Study Site
New York, New York, United States
89bio Clinical Study Site
Bellevue, Washington, United States
89bio Clinical Study Site
Seattle, Washington, United States
89bio Clinical Study Site
Seattle, Washington, United States
89bio Clinical Study Site
Tacoma, Washington, United States
Worth passing on?
Save it to the Care Package and send it to them, or to their doctor, in one message. Whether they follow it up is theirs to decide.
Review the Care PackageThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.