A Phase 3, randomised, double-blind, parallel-group, 76-week, efficacy and safety study of BI 456906 administered subcutaneously compared with placebo in participants with overweight or obesity and type 2 diabetes mellitus

This study, called a Phase 3 trial, is a very important step in checking if a new medicine, BI 456906, is effective and safe. It's designed for adults who are overweight or have obesity and also live with type 2 diabetes. The main goal is to see if this new medicine, given as an injection under the skin, can help people lose weight and manage their diabetes better, compared to a 'dummy' medicine (placebo).

When we say 'randomised,' it means that participants are put into groups by chance, like flipping a coin. Some will get the new medicine, and others will get the placebo. 'Double-blind' means that neither you nor your study doctor will know whether you're receiving the actual medicine or the placebo. This is a very common and important way to make sure the study results are fair and accurate, so we can clearly see the real effects of the medicine.

Over the 76 weeks (about 1 year and 5 months), we will carefully track changes in body weight, whether people achieve a certain amount of weight loss (like 5% or more of their body weight), and how their diabetes markers, like HbA1c, change. We will also look at other important measurements such as waist size and blood pressure. Understanding these changes will help us decide if BI 456906 could be a helpful new treatment option in the future.