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 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.

Official registry: https://clinicaltrials.gov/study/NCT06215716 · Akero Therapeutics, Inc · enrollment listed as 1,650

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 Efruxifermin, or Placebo. The registry lists allocation as randomized. 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).

They plan to enroll about 1,650 people at 293 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis

Interventions: Efruxifermin, Placebo

Primary outcome (registry wording): Cohort 1 Only: Resolution of NASH/MASH and a ≥ 1 stage improvement in fibrosis

Who it is for (from inclusion criteria)

  • Ages 18 Years to 80 Years
  • Males and non-pregnant, non-lactating females between 18 - 80 years of age inclusive, based on the date of the screening visit
  • Previous history or presence of 2 out of 4 components of metabolic syndrome (obesity, dyslipidemia, elevated blood pressure, elevated fasting glucose) or type 2 diabetes
  • Cohort 1: Biopsy-proven NASH/MASH. Must have had a liver biopsy obtained ≤ 180 days prior to screening with fibrosis stage 2 or 3 and a non-alcoholic fatty liver disease (NAFLD) activity score (NAS) of ≥ 4 with at least a score of 1 in each of the following NAS components:
  • Steatosis (scored 0 to 3),
  • Ballooning degeneration (scored 0 to 2), and
  • Lobular inflammation (scored 0 to 3)
  • Cohort 2: Biopsy-proven fibrosis stage 3. Must have had a liver biopsy obtained ≤ 180 days prior to screening. Subjects with NAS \<4 may be enrolled and are not required to meet 1 point in each of the components of NAS

Public study contact (from the registry)

Akero Study Director

650-487-6488

AkeroSynchrony@akerotx.com

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

Sites listed on ClinicalTrials.gov

293 listed

+ 130 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)

FAQ about this NCT record

Is NCT06215716 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 NCT06215716?

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 NCT06215716?

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