A Study to Test Whether Survodutide Helps People Living With Obesity or Overweight and With a Confirmed or Presumed Liver Disease Called Non-alcoholic Steatohepatitis (NASH) to Reduce Liver Fat and to Lose Weight (SYNCHRONIZE-MASLD)
Public ClinicalTrials.gov record NCT06309992. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Multicentre, Randomised, Double-blind, Placebo-controlled, 48-week, Phase III Trial to Evaluate the Efficacy and Safety of Survodutide Administered Subcutaneously in Participants With Overweight or Obesity and Presumed or Confirmed Nonalcoholic Steatohepatitis (NASH)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study is open to adults who are at least 18 years old and have * presumed or confirmed NASH together with overweight or obesity and * a body mass index (BMI) of 30 kg/m² or more, or * a BMI of 27 kg/m² and at least one weight-related health problem. People with a history of other chronic liver diseases cannot take part in this study. The purpose of this study is to find out whether a medicine called survodutide helps people living with obesity or overweight and a confirmed or presumed liver disease called nonalcoholic steatohepatitis (NASH) to have less liver fat and to lose weight. Participants are put into 2 groups randomly, which means by chance. 1 group gets different doses of survodutide and 1 group gets placebo. Placebo looks like survodutide but does not contain any medicine. Every participant has a 2 in 3 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 for about 1 year. In addition to the study medicine, all participants receive counselling to make changes to their diet and to exercise regularly. Participants are in the study for about 1 year and 3 months. During this time, it is planned that participants visit the study site up to 14 times and receive 3 phone calls by the site staff. The doctors check participants' health and take note of any unwanted effects. The participants' body weight is regularly measured. At 3 of the visits, the participants' liver is measured using different imaging methods. The results are compared between the groups to see whether the treatment works.
Study identification
- NCT ID
- NCT06309992
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 218 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 1, 2024
- Primary completion
- Oct 8, 2025
- Completion
- Dec 1, 2025
- Last update posted
- Apr 29, 2026
2024 – 2025
United States locations
- U.S. sites
- 33
- U.S. states
- 12
- U.S. cities
- 32
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| ARK Clinical Research | Fountain Valley | California | 92708 | — |
| Velocity Clinical Research-Gardena-69773 | Gardena | California | 90247 | — |
| ARK Clinical Research | Long Beach | California | 92657 | — |
| Catalina Research Institute, LLC | Montclair | California | 91763 | — |
| Velocity Clinical Research-North Hollywood-69852 | North Hollywood | California | 91606 | — |
| Velocity Clinical Research-Panorama City-68861 | Panorama City | California | 91402 | — |
| Velocity Clinical Research, Santa Ana | Santa Ana | California | 92704 | — |
| Excel Medical Clinical Trials | Boca Raton | Florida | 33434 | — |
| Segal Drug Trials | Delray Beach | Florida | 33484 | — |
| Fleming Island Center for Clinical Research | Fleming Island | Florida | 32003 | — |
| Covenant Metabolic Specialists, LLC - Fort Myers | Fort Myers | Florida | 33912 | — |
| Velocity Clinical Research-Hallandale Beach-67888 | Hallandale | Florida | 33009 | — |
| Nature Coast Clinical Research-Inverness-48221 | Inverness | Florida | 34452 | — |
| Health Awareness, Inc. | Jupiter | Florida | 33458 | — |
| Verus Clinical Research Corporation | Miami | Florida | 33135 | — |
| Panax Clinical Research | Miami Lakes | Florida | 33014 | — |
| Covenant Research and Clinics, LLC | Sarasota | Florida | 34240 | — |
| Springfield Clinic, LLP | Springfield | Illinois | 62702 | — |
| Indiana University | Indianapolis | Indiana | 46202 | — |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | — |
| Kansas Medical Clinic PA | Topeka | Kansas | 66606-1707 | — |
| Louisiana Research Center, LLC | Shreveport | Louisiana | 71105 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| DSI Research Northridge LLC | Dayton | Ohio | 45414 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| Velocity Clinical Research, Austin | Austin | Texas | 78759 | — |
| Amel Med LLC | Georgetown | Texas | 78628 | — |
| Gastroenterology and Liver Research LLC | Houston | Texas | 77043 | — |
| Biopharma Informatic, Inc. Research Center | Houston | Texas | 77084 | — |
| Accurate Clinical Research, Inc. | Humble | Texas | 77346 | — |
| Clinical Trials of Texas, LLC | San Antonio | Texas | 78229 | — |
| Velocity Clinical Research, Waco | Waco | Texas | 76710 | — |
| GI Select Health Research LLC | Richmond | Virginia | 23236 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 4 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06309992, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 29, 2026 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06309992 live on ClinicalTrials.gov.