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)

This is a registry record, not a result. A trial being listed, recruiting or completed says nothing by itself about whether the compound works or is safe.

Registry numberNCT06309992
StatusCompleted
PhasePhase 3
SponsorBoehringer Ingelheim
Enrollment218 participants
DesignInterventional, Randomized, Parallel, Masking: Quadruple
ConditionsObesity; Non-Alcoholic SteatoHepatitis (NASH)
InterventionsSurvodutide; Placebo
StartApr 2, 2024
Primary completionOct 9, 2025
Study completionDec 2, 2025
Results postedNot yet
Registry last updatedApr 30, 2026

Compounds on this site that cite this trial

What the registry says the trial is about

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.

Primary outcomes

These are what the trial was designed to measure first. They are registered in advance, which is what makes a later result checkable.

Outcome measureTime frame
Relative reduction in liver fat content of at least 30% from baseline to Week 48 (yes/no) assessed by magnetic resonance imaging proton density fat fraction (MRI-PDFF) [%]at baseline, at week 48
Relative change (%) in body weight [kg] from baseline to Week 48at baseline, at week 48

13 secondary outcomes also registered. See the registry record for the full list.

Source: ClinicalTrials.gov (U.S. National Library of Medicine). Last checked against the registry on Oct 3, 2026. See the trial changes feed for what has changed recently.