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)

What Was Tested

This registered phase 3 trial tested Survodutide.

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.

It had two arms (groups): Treatment arm (experimental) and Placebo arm (placebo comparator).

The registry classes the interventions as combination product.

Who Took Part

Enrollment: 218 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Age ≥18 years at the time of signing informed consent, and at least the legal age of consent in countries where it is \>18 years. BMI ≥30 kg/m², OR BMI ≥27 kg/m² and at least one of the following weight-related comorbidities at screening:. Obstructive sleep apnoea. History of at least one self-reported unsuccessful dietary effort to lose body weight Further inclusion criteria apply.

The full record lists 8 inclusion and 6 exclusion criteria; among the exclusions: current decompensated liver disease or previous hepatic decompensation (ascites, spontaneous bacterial peritonitis, portal hypertension bleeding, hepatic encephalopathy, hepatorenal syndrome); evidence of portal hypertension (e.g. splenomegaly, oesophageal varices, or other portosystemic collateral pathways).

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

The participants were allocated by chance, so the Survodutide group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

As a double-blind Survodutide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2024-04-02 with completion listed for 2025-10-09.

It ran at 37 sites in United States (33) and Spain (4).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Relative change (%) in body weight [kg] from baseline to Week 48 (time frame: at baseline, at week 48).

It also tracked 13 secondary outcomes, for example Absolute change from baseline to Week 48 in liver fat content assessed by MRI-PDFF [%], Relative change (%) from baseline to Week 48 in liver fat content assessed by MRI-PDFF [%], Absolute change from baseline to Week 48 in alanine amino transferase (ALT) [U/L] levels, Relative change from baseline to Week 48 in alanine amino transferase (ALT) [U/L] levels, Absolute change from baseline to Week 48 in waist circumference [cm] and Relative change from baseline to Week 48 in waist circumference [cm].

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Survodutide in 218 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Survodutide compound page, all human trials.