Survodutide: Subcutaneous injection, pre-filled syringe
Placebo matching survodutide: Subcutaneous injection, pre-filled syringe
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.
| Facility | City | Region | Status |
|---|---|---|---|
| The Institute for Liver Health II DBA Arizona Clinical Trials | Peoria | Arizona | Recruiting |
| Scottsdale Medical Specialists, Ltd | Scottsdale | Arizona | Recruiting |
| Adobe Clinical Research, LLC | Tucson | Arizona | Recruiting |
| Arizona Liver Health - Tucson | Tucson | Arizona | Recruiting |
| Del Sol Research Management, LLC | Tucson | Arizona | Recruiting |
| Hope Clinical Research | Canoga Park | California | Recruiting |
| Velocity Clinical Research-Chula Vista | Chula Vista | California | Recruiting |
| Southern California Research Center | Coronado | California | Recruiting |
| ARK Clinical Research | Fountain Valley | California | Recruiting |
| Velocity Clinical Research-Huntington Park | Huntington Park | California | Recruiting |
| 310 Clinical Research | Inglewood | California | Recruiting |
| Velocity Clinical Research, San Diego | La Mesa | California | Recruiting |
| Om Research, LLC | Lancaster | California | Recruiting |
| Catalina Research Institute, LLC | Montclair | California | Recruiting |
| Clinnova Research Solutions | Orange | California | Recruiting |
| Fomat Medical Research | Oxnard | California | Recruiting |
| Cadena Care Institute, LLC | Poway | California | Recruiting |
| Ficramed Research Institute | Poway | California | Recruiting |
| Inland Empire Clinical Trials, LLC | Rialto | California | Recruiting |
| Metro Clinical Trials | San Bernardino | California | Recruiting |
| Acclaim Clinical Research | San Diego | California | Recruiting |
| Future Innovative Treatments | Colorado Springs | Colorado | Recruiting |
| South Denver Gastroenterology PC | Englewood | Colorado | Recruiting |
| Connecticut Gastroenterology Clinical Research Foundation | Bristol | Connecticut | Recruiting |
| Synergy Healthcare | Bradenton | Florida | Recruiting |
| Synergy Healthcare of Tampa | Brandon | Florida | Recruiting |
| Access research Institute | Brooksville | Florida | Recruiting |
| Hi Tech and Global Research, LLC | Coral Gables | Florida | Recruiting |
| Cenara Clinical Research | Cutler Bay | Florida | Recruiting |
| Covenant Metabolic Specialists, LLC - Fort Myers | Fort Myers | Florida | Recruiting |
| Neoclinical Research | Hialeah | Florida | Recruiting |
| Evolution Clinical Trials | Hialeah Gardens | Florida | Recruiting |
| Global Research Associates | Homestead | Florida | Recruiting |
| Lake Center for Clinical Research | Lady Lake | Florida | Recruiting |
| Research Associates of South Florida, LLC | Miami | Florida | Recruiting |
| Optimus U Corporation-Miami-69452 | Miami | Florida | Recruiting |
| Schiff Center Liver Diseases | Miami | Florida | Recruiting |
| BioMed Research & Medical Center | Miami | Florida | Recruiting |
| MplusM - Century Research | Miami | Florida | Recruiting |
| ECIR Miami Holdings LLC dba IMIC | Miami | Florida | Recruiting |
+ 405 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06632457 on ClinicalTrials.gov ↗ ← All trials in India