The Phase 3 study (NCT06066528) investigating Survodutide (BI 456906) for individuals living with overweight or obesity who also have type 2 diabetes completed its primary endpoint on 2025-12-12. This milestone indicates that data collection for the trial's main objective has concluded.

Background

The study, titled "A Study to Test Whether Survodutide (BI 456906) Helps People Living With Overweight or Obesity Who Also Have Diabetes to Lose Weight," aims to evaluate the efficacy of survodutide in promoting weight loss. It focuses on adults aged 18 years or older with a body mass index of 27 kg/m² or more, who have type 2 diabetes and have not previously managed to lose weight through diet changes alone or are on specific diabetes medications.

Trial design

The Phase 3 study (NCT06066528) was a randomized trial with an enrollment of 755 participants. The trial investigated survodutide (BI 456906) in adults diagnosed with obesity or who are overweight and also have type 2 diabetes mellitus. Participants were divided into 3 groups by chance, receiving either survodutide or placebo. The primary objective of the study is to determine if survodutide helps these individuals lose weight.

What this means

The completion of the primary endpoint for the Survodutide trial signifies a critical step in its development. While specific results are not yet available, this milestone indicates that all necessary data for the primary outcome have been collected. The next stages will involve data analysis and the subsequent reporting of findings, which will provide insights into survodutide's potential role in managing overweight or obesity in individuals with type 2 diabetes.

Source

The information regarding the primary completion of this trial was obtained from ClinicalTrials.gov, a public database of clinical studies. The study record for NCT06066528, titled "A Study to Test Whether Survodutide (BI 456906) Helps People Living With Overweight or Obesity Who Also Have Diabetes to Lose Weight," was updated on 2025-12-12 on clinicaltrials.gov.