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RECRUITING Phase 3

A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis

NCT06215716 · View on ClinicalTrials.gov ↗

Study Summary

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.

Interventions

  • DRUG Placebo
  • DRUG Efruxifermin

Study Locations (20)

Arizona

  • Akero Clinical Study Site — Chandler
  • Akero Clinical Study Site — Flagstaff
  • Akero Clinical Study Site — Mesa
  • Akero Clinical Study Site — Peoria
  • Akero Clinical Study Site — Tucson
  • Akero Clinical Study Site — Tucson
  • Akero Clinical Study Site — Tucson
  • Akero Clinical Study Site — Tucson

California

  • Akero Clinical Study Site — Chula Vista
  • Akero Clinical Study Site — Coronado
  • Akero Clinical Study Site — Escondido
  • Akero Clinical Study Site — Folsom
  • Akero Clinical Study Site — Inglewood
  • Akero Clinical Study Site — La Mesa

Arkansas

  • Akero Clinical Study Site — Conway
  • Akero Clinical Study Site — Jonesboro
  • Akero Clinical Study Site — Little Rock
  • Akero Clinical Study Site — North Little Rock

Alabama

  • Akero Clinical Study Site — Birmingham
  • Akero Clinical Study Site — Dothan

Trial Details

FieldValue
Enrollment Target 1,650 participants
Start Date 2023-12-01
Est. Completion 2032-11
Phase Phase 3

Sponsor

Akero Therapeutics

4 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06215716

The ClinicalTrials.gov registry entry for NCT06215716 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,650 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Akero Therapeutics, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with MASH With Fibrosis appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06215716 reports 20 study locations spanning 4 distinct geographic areas — top geographies include Arizona, California, Arkansas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06215716 about?

NCT06215716 is a clinical study titled "A Study Evaluating 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.

What is the current status of trial NCT06215716?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 1,650 participants. The study started on 2023-12-01. Estimated completion is 2032-11.

What conditions does trial NCT06215716 study?

This clinical trial studies the following conditions: MASH With Fibrosis, NASH With Fibrosis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06215716?

The interventions under investigation include: Placebo (DRUG), Efruxifermin (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06215716?

This trial is sponsored by Akero Therapeutics, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06215716 being conducted?

This trial has 20 study locations across Alabama, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial