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LIVERAGE™ - Cirrhosis: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Cirrhosis
NCT06632457 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06632457
The ClinicalTrials.gov registry entry for NCT06632457 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 1,590 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boehringer Ingelheim, which has 203 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. 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: NCT06632457 reports 20 study locations spanning 2 distinct geographic areas — top geographies include California, Arizona. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06632457?
The interventions under investigation include: Survodutide (COMBINATION_PRODUCT), Placebo matching survodutide (COMBINATION_PRODUCT). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06632457?
This trial is sponsored by Boehringer Ingelheim, which has 203 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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