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Taking people in Puerto RicoPhase 3

Tests efruxifermin in adults with liver scarring from fatty liver disease

Tests efruxifermin against a placebo in adults with fatty liver disease and mild liver scarring.

Plain-language title generated from the registry record
Registry title: A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis

Key facts

Where
Manati, Mayagüez, and San Juan, Puerto RicoSee the 3 sites
Phase
Phase 3

AI summary: who the study is looking for

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with NASH/MASH (fatty liver disease with liver inflammation) and liver scarring (fibrosis) stage 2 or 3, without cirrhosis, confirmed by a recent liver biopsy.

Age
18 to 80 years
Sex
Men and women. Women cannot be pregnant or breastfeeding.
Disease stage
NASH/MASH with fibrosis stage 2 or 3, no cirrhosis. Cohort 1: fibrosis stage 2 or 3 and NAS of 4 or more. Cohort 2: fibrosis stage 3, NAS can be below 4.
Biomarker or test result
A liver biopsy taken 180 days or less before screening that shows NASH/MASH or fibrosis. Cohort 1 needs a score of at least 1 in steatosis, ballooning and lobular inflammation.

Main reasons for not taking part

  • Other causes of liver disease
  • Cirrhosis on liver biopsy (fibrosis stage 4)
  • Type 1 diabetes
  • Uncontrolled type 2 diabetes
  • Pregnant or breastfeeding women

Read by machine on 12 November 2026.

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 80 years old?

Source: NCT06215716, who can take part

Where in Puerto Rico

  • ManatiHospital not named in the registryContact: Akero Site 0177Taking people
  • MayagüezHospital not named in the registryContact: Akero Site 0272Taking people
  • San JuanHospital not named in the registryContact: Akero Site 9215Taking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Trial details

Who runs it
Akero Therapeutics, Inc
Trial code
NCT06215716
Record updated
6 November 2026
Original description
This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in subjects with non-cirrhotic NASH/MASH and fibrosis stage 2 or 3 (F2 or F3).Read full original descriptionShow less

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

This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled 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.

Inclusion: 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.

Exclusion: Type 1 or uncontrolled Type 2 diabetes; Other inclusion and exclusion criteria may apply; Other causes of liver disease based on medical history and/or liver histology and/or central laboratory results; Presence of cirrhosis on liver biopsy (fibrosis stage 4).

ClinicalTrials.gov NCT06215716