Condition: Metabolic Dysfunction Associated Steatohepatitis (MASH) · Liver Fibrosis · Sponsor: Boehringer Ingelheim
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 a…
This description comes directly from the study's public registry record.
Boehringer Ingelheim · 1-800-243-0127 · clintriage.rdg@boehringer-ingelheim.com
Always discuss trial participation with your own doctor first.
| University of Alabama at Birmingham | Birmingham, Alabama, United States | Not Yet Recruiting |
| The Institute for Liver Health II DBA Arizona Clinical Trials | Peoria, Arizona, United States | Recruiting |
| Scottsdale Medical Specialists, Ltd | Scottsdale, Arizona, United States | Recruiting |
| Adobe Clinical Research, LLC | Tucson, Arizona, United States | Recruiting |
| Arizona Liver Health - Tucson | Tucson, Arizona, United States | Recruiting |
| Del Sol Research Management, LLC | Tucson, Arizona, United States | Recruiting |
| Hope Clinical Research | Canoga Park, California, United States | Recruiting |
| Velocity Clinical Research-Chula Vista | Chula Vista, California, United States | Recruiting |
| Southern California Research Center | Coronado, California, United States | Recruiting |
| ARK Clinical Research | Fountain Valley, California, United States | Recruiting |
| Fresno Clinical Research Center | Fresno, California, United States | Recruiting |
| Velocity Clinical Research-Gardena-69773 | Gardena, California, United States | Recruiting |
+ 513 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT06632444