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NCT06215716 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of MASH With Fibrosis and NASH With Fibrosis, sponsored by Akero Therapeutics.

Recruiting
Registry status
Phase 3
Development phase
1,650
Enrollment target
20
Study locations

NCT06215716 is a Phase 3 study of MASH With Fibrosis and NASH With Fibrosis that is actively recruiting participants, run by Akero Therapeutics. The registered enrollment target is 1,650 participants. The trial reports 20 study locations across 4 states.

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The verdict

NCT06215716, a Phase 3 study of MASH With Fibrosis and NASH With Fibrosis, is actively recruiting participants, sponsored by Akero Therapeutics.

RECRUITING
Registry status
Phase 3
Development phase
1,650 participants
Enrollment target
20
Study locations

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

6 total trials

What the Registry Record Tells You About NCT06215716

The ClinicalTrials.gov registry entry for NCT06215716 describes a study currently listed as recruiting, categorized as Phase 3. 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 6 total studies on file at ClinicalTrials.gov.

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.

NCT06215716 reports 20 study locations spanning 4 distinct geographic areas - top geographies include Arizona, California, Arkansas.

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.

What interventions are being tested in trial NCT06215716?

The interventions under investigation include: Placebo (DRUG), Efruxifermin (DRUG).

Who is sponsoring clinical trial NCT06215716?

This trial is sponsored by Akero Therapeutics, which has 6 total clinical trials registered on ClinicalTrials.gov.

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.

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