The Phase 3 SYNCHRONIZE-MASLD trial for Survodutide, investigating its role in treating individuals with obesity or overweight and Non-alcoholic Steatohepatitis (NASH), completed its primary data collection on 2025-10-09. This milestone marks the conclusion of the main data gathering period for the study, which enrolled 218 participants.
Background
Survodutide is being evaluated for its potential in managing metabolic conditions. The trial specifically targets individuals living with obesity or overweight who also have a confirmed or presumed liver disease known as Non-alcoholic Steatohepatitis (NASH).
Trial design
The SYNCHRONIZE-MASLD study (NCT06309992) is a Phase 3 clinical trial that enrolled 218 adult participants. The trial's objective is to assess whether survodutide can help individuals with obesity or overweight and confirmed or presumed Non-alcoholic Steatohepatitis (NASH) to reduce liver fat and achieve weight loss. Participants were required to be at least 18 years old and have a BMI of 30 kg/m² or more, or a BMI of 27 kg/m² with at least one weight-related health problem. The study design included intervention arms of survodutide and placebo.
What this means
The primary completion of the SYNCHRONIZE-MASLD trial signifies that all planned primary data collection for survodutide in this patient population has concluded. The next steps will involve data analysis to determine the efficacy and safety profile of survodutide in treating obesity or overweight in conjunction with NASH. The findings from this Phase 3 study will be crucial for understanding its potential clinical utility for these interconnected metabolic and liver conditions.
Source
The information regarding the primary completion of this trial was obtained from ClinicalTrials.gov, a public database of clinical studies. The update for study NCT06309992, titled "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)," was posted on 2025-10-09 on clinicaltrials.gov.
