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NCT06632444 · ClinicalTrials.gov registry record · Phase 3

LIVERAGE™: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Moderate or Advanced Liver Fibrosis

A Phase 3 study of Liver Fibrosis and Metabolic Dysfunction-Associated Steatohepatitis (MASH), sponsored by Boehringer Ingelheim.

Recruiting
Registry status
Phase 3
Development phase
1,800
Enrollment target
20
Study locations

NCT06632444: Recruiting Phase 3 study of Liver Fibrosis and Metabolic Dysfunction-Associated Steatohepatitis (MASH), sponsored by Boehringer Ingelheim.

NCT06632444 is a Phase 3 study of Liver Fibrosis and Metabolic Dysfunction-Associated Steatohepatitis (MASH) that is actively recruiting participants, run by Boehringer Ingelheim. The registered enrollment target is 1,800 participants, above the 209-participant average among 11 other Liver Fibrosis trials with a reported enrollment target (761% higher). The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06632444, a Phase 3 study of Liver Fibrosis and Metabolic Dysfunction-Associated Steatohepatitis (MASH), is actively recruiting participants, sponsored by Boehringer Ingelheim.

RECRUITING
Registry status
Phase 3
Development phase
1,800 participants
Enrollment target
20
Study locations

Study Summary

This study is open to adults who are at least 18 years old living with obesity and have: * a confirmed liver disease called non-alcoholic steatohepatitis (NASH)/metabolic associated steatohepatitis (MASH) and * moderate or advanced liver fibrosis People with a history of acute or chronic liver diseases other than MASH or chronic alcohol intake cannot take part in this study. The purpose of this study is to find out whether a medicine called survodutide helps people with MASH and moderate or advanced liver fibrosis improve their liver function. This study has 2 parts. The purpose of the first part of this study is to find out the effect of survodutide on MASH and liver fibrosis. The purpose of the second part is to find out how safe and effective survodutide is in improving liver function. Participants are put into 2 groups randomly, which means by chance. 1 group gets survodutide and 1 group gets placebo. Placebo looks like survodutide but does not contain any medicine. Each participant has twice the chance of getting survodutide. Participants and doctors do not know who is in which group. Participants inject survodutide or placebo under their skin once a week. The survodutide doses are slowly increased until the target dose is reached. All participants receive counselling to make changes to their diet and to exercise regularly. Participants are in the study for up to 7 years. During this time, they regularly visit the study site or have remote visits by video call. For about the first year of the study, participants have these visits every 2 weeks, increasing to every 4 weeks and then every 6 weeks. After being in the study for a little over a year participants will then alternate between visiting the study site or having a remote visit every 3 months until the end of the study. The doctors check participants' health and take note of any unwanted effects. The participants' body weight and effects on the stomach and intestines are regularly measured. At some vi

Conditions Studied

Liver Fibrosis Metabolic Dysfunction-Associated Steatohepatitis (MASH)

Interventions

  • COMBINATION_PRODUCT Placebo
  • COMBINATION_PRODUCT Survodutide

Study Locations (20)

California

  • Hope Clinical Research - Canoga Park
  • Velocity Clinical Research-Chula Vista - Chula Vista
  • Southern California Research Center - Coronado
  • University of California San Francisco - Fresno
  • Velocity Clinical Research-Gardena-69773 - Gardena
  • Velocity Clinical Research-Huntington Park - Huntington Park
  • 310 Clinical Research - Inglewood
  • Velocity Clinical Research, San Diego - La Mesa
  • Om Research, LLC - Lancaster
  • ARK Clinical Research - Long Beach
  • Velocity Clinical Research, Westlake - Los Angeles
  • Catalina Research Institute, LLC - Montclair
  • Velocity Clinical Research - Boise - North Hollywood
  • Clinnova Research Solutions - Orange

Arizona

  • The Institute for Liver Health II DBA Arizona Clinical Trials - Peoria
  • Scottsdale Medical Specialists, Ltd - Scottsdale
  • Adobe Clinical Research, LLC - Tucson
  • Arizona Liver Health - Tucson - Tucson
  • Del Sol Research Management, LLC - Tucson

Alabama

  • University of Alabama at Birmingham - Birmingham

Trial Details

FieldValue
Enrollment Target 1,800 participants
Start Date 2024-09-17
Est. Completion 2031-12-27
Phase Phase 3
Boehringer Ingelheim

515 total trials

What NCT06632444 shows while recruiting

NCT06632444 is an interventional study that assigns participants to a tested intervention. Its 1,800 participants enrollment target places it among the larger protocols in the corpus, above the 209-participant average among 11 other Liver Fibrosis trials with a reported enrollment target (761% higher).

The record links to 2 conditions, with Liver Fibrosis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT06632444 names 20 study sites across 3 states, led by California, Arizona, Alabama.

Frequently Asked Questions

What is clinical trial NCT06632444 about?

NCT06632444 is a clinical study titled "LIVERAGE™: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Moderate or Advanced Liver Fibrosis". This study is open to adults who are at least 18 years old living with obesity and have: * a confirmed liver disease called non-alcoholic steatohepatitis (NASH)/metabolic associated steatohepatitis (MASH) and * moderate or advanced liver fibrosis People with a history of acute or chronic liver dis...

What is the current status of trial NCT06632444?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 1,800 participants. The study started on 2024-09-17. Estimated completion is 2031-12-27.

What conditions does trial NCT06632444 study?

This clinical trial studies the following conditions: Liver Fibrosis, Metabolic Dysfunction-Associated Steatohepatitis (MASH).

What interventions are being tested in trial NCT06632444?

The interventions under investigation include: Placebo (COMBINATION_PRODUCT), Survodutide (COMBINATION_PRODUCT).

Who is sponsoring clinical trial NCT06632444?

This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06632444 being conducted?

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

Learn More About Clinical Trials

Similar trials for Liver Fibrosis

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06632444's enrollment target sits among peer trials

1,800 1st of 11 higher than 11 of 11 other Liver Fibrosis trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Liver Fibrosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT06632444

Source: ClinicalTrials.gov NCT06632444, the US trial registry maintained by the National Library of Medicine. NCT06632444 (large enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.