Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingPhase 3interventionalRules rewrite

Phase 3: testing Pegozafermin for Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH) With Fibrosis

The study will assess the how well it works and safety of 2 dose regimens of pegozafermin compared to dummy treatment (placebo) for the treatment of liver fibrosis stage F2 or F3 in adult participants with MASH.

Official registry: https://clinicaltrials.gov/study/NCT06318169 · Hoffmann-La Roche · enrollment listed as 1,350

What this phase means

Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Pegozafermin, or Placebo. The registry lists allocation as randomized. The study will assess the how well it works and safety of 2 dose regimens of pegozafermin compared to dummy treatment (placebo) for the treatment of liver fibrosis stage F2 or F3 in adult participants with MASH.

They plan to enroll about 1,350 people at 306 sites. Taking part typically means an infusion or injection of a biologic plus check-ins.

Official title (unrewritten)

A Phase 3 Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects With Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis

Interventions: Pegozafermin, Placebo

Primary outcome (registry wording): Number of Participants With at Least an Improvement of Fibrosis ≥1 Stage Without Worsening of Steatohepatitis at Week 52

Who it is for (from inclusion criteria)

  • Ages 18 Years to 80 Years
  • Biopsy-confirmed MASH with fibrosis stage F2 or F3
  • Body mass index (body-mass index (BMI)) at screening ≥25.0 kilograms (kg)/meters squared (m\^2) (≥23 kg/m\^2 for Asian participants)

Public study contact (from the registry)

Reference Study ID Number: BIO89-100-131 ENLIGHTEN clinical trial / No attachments to email below.

888-662-6728 (U.S. Only)

global-roche-genentech-trials@gene.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

306 listed

+ 171 sites outside the US on the same record

Related recruiting trials in this snapshot

RecruitingNot a traditional drug phaseMontreal, Quebec
Not a traditional drug phase: Acoustic radiation force impulse (ARFI), magnetic resonance elastography (MRE) for Nonalcoholic Fatty Liver Disease (NAFLD)

Nonalcoholic fatty liver disease is the most common liver disease in Western countries, due in large part to its association with type 2 diabetes and obesity. The more advanced form of this disease is known as nonalcoholic steatohepatitis (NASH).

NCT03572465 · Official ClinicalTrials.gov record · Centre hospitalier de l'Université de Montréal (CHUM)

RecruitingPhase 3Birmingham, Alabama
Phase 3: testing Efruxifermin for NASH With Fibrosis

This is a multi-center evaluation of efruxifermin (EFX) in a randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment study in subjects with non-cirrhotic NASH/MASH and fibrosis stage 2 or 3 (F2 or F3). The study will enroll subjects in two cohorts for a total samples size of 1650 subjects.

NCT06215716 · Official ClinicalTrials.gov record · Akero Therapeutics, Inc

FAQ about this NCT record

Is NCT06318169 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT06318169?

Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT06318169?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary