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NCT06632457 · ClinicalTrials.gov registry record · Phase 3
LIVERAGE™ - Cirrhosis: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Cirrhosis
A Phase 3 study of Metabolic Dysfunction-associated Steatohepatitis, sponsored by Boehringer Ingelheim.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 1,590
- Enrollment target
- 20
- Study locations
NCT06632457: Recruiting Phase 3 study of Metabolic Dysfunction-associated Steatohepatitis, sponsored by Boehringer Ingelheim.
NCT06632457 is a Phase 3 study of Metabolic Dysfunction-associated Steatohepatitis that is actively recruiting participants, run by Boehringer Ingelheim. The registered enrollment target is 1,590 participants, above the 103-participant average among 5 other Metabolic Dysfunction-associated Steatohepatitis trials with a reported enrollment target (1444% higher). The trial reports 20 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06632457, a Phase 3 study of Metabolic Dysfunction-associated Steatohepatitis, is actively recruiting participants, sponsored by Boehringer Ingelheim.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 1,590 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study is open to adults who are at least 18 years old and have: * A confirmed liver disease called non-alcoholic steatohepatitis (NASH) or * A confirmed liver disease called metabolic-associated steatohepatitis (MASH) * BMI of 27 kg/m2 or more or * 25 kg/m2 or more if the participant is Asian. People with a history of other chronic liver diseases or high 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 NASH or MASH improve their 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. All participants regularly receive counselling to make changes to their diet and to exercise regularly. Participants are in the study for up to 4 and a half years. During this time, they visit the study site or have a remote visit by video call every 2, 4 or 6 weeks for about a 1 year and 5 months. After this time participants visit the trial site or have 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 is regularly measured. At some visits the liver parameters are measured using different imaging methods. The participants also fill in questionnaires about their symptoms. The results are compared between the groups to see whether the treatment works.
Primary Outcome
MELD = model of end-stage liver disease CSPH = Clinically significant portal hypertension
Conditions Studied
Interventions
- COMBINATION_PRODUCT Survodutide
- COMBINATION_PRODUCT Placebo matching survodutide
Study Locations (20)
California
- Hope Clinical Research - Canoga Park
- Velocity Clinical Research-Chula Vista - Chula Vista
- Southern California Research Center - Coronado
- ARK Clinical Research - Fountain Valley
- Velocity Clinical Research-Huntington Park - Huntington Park
- 310 Clinical Research - Inglewood
- Velocity Clinical Research, San Diego - La Mesa
- Om Research, LLC - Lancaster
- Catalina Research Institute, LLC - Montclair
- Clinnova Research Solutions - Orange
- Fomat Medical Research - Oxnard
- Cadena Care Institute, Llc - Poway
- Ficramed Research Institute - Poway
- Inland Empire Clinical Trials, LLC - Rialto
- Metro Clinical Trials - San Bernardino
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
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,590 participants |
| Start Date | 2024-11-07 |
| Est. Completion | 2029-06-05 |
| Phase | Phase 3 |
What NCT06632457 shows while recruiting
NCT06632457 is an interventional study that assigns participants to a tested intervention. Its 1,590 participants enrollment target places it among the larger protocols in the corpus, above the 103-participant average among 5 other Metabolic Dysfunction-associated Steatohepatitis trials with a reported enrollment target (1444% higher).
The record links to 1 condition, with Metabolic Dysfunction-associated Steatohepatitis appearing as the primary indexed condition, and to 2 interventions - of which Survodutide is the first listed.
NCT06632457 names 20 study sites across 2 states, led by California, Arizona.
Frequently Asked Questions
What is clinical trial NCT06632457 about?
NCT06632457 is a clinical study titled "LIVERAGE™ - Cirrhosis: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Cirrhosis". This study is open to adults who are at least 18 years old and have: * A confirmed liver disease called non-alcoholic steatohepatitis (NASH) or * A confirmed liver disease called metabolic-associated steatohepatitis (MASH) * BMI of 27 kg/m2 or more or * 25 kg/m2 or more if the participant is Asian....
What is the current status of trial NCT06632457?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 1,590 participants. The study started on 2024-11-07. Estimated completion is 2029-06-05.
What conditions does trial NCT06632457 study?
This clinical trial studies the following conditions: Metabolic Dysfunction-associated Steatohepatitis.
What interventions are being tested in trial NCT06632457?
The interventions under investigation include: Survodutide (COMBINATION_PRODUCT), Placebo matching survodutide (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT06632457?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06632457 being conducted?
This trial has 20 study locations across Arizona, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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