The Phase 3 study of Survodutide (BI 456906) in Japanese adults living with obesity completed its primary data collection on 2025-12-03. This trial, identified as NCT06176365, enrolled 274 participants to evaluate the investigational drug's effect.
Background
Survodutide is being investigated as a potential treatment for obesity. The study specifically focused on Japanese adults with obesity, aiming to address the needs of this population.
Trial design
The study, titled 'A Study to Test Whether Survodutide Helps Japanese People Living With Obesity Disease' (NCT06176365), is a Phase 3 trial. It enrolled 274 participants aged 18 years or older who had a body mass index (BMI) of 35 kg/m² or more with at least one weight-related health problem, or a BMI of 27 kg/m² or more with at least two weight-related health problems. Participants had conditions such as type 2 diabetes, high blood pressure, or increased blood lipids, and had not previously managed to lose weight through diet changes. The interventions included survodutide and a placebo matching survodutide.
What this means
The completion of primary data collection for this Phase 3 trial marks a significant milestone in the development of Survodutide for obesity in the Japanese population. This step indicates that all planned data points for the primary endpoints have been collected, moving the study closer to analysis and potential reporting of results. The findings from this trial will be crucial for understanding the efficacy and safety profile of Survodutide in this specific demographic.
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 NCT06176365, titled 'A Study to Test Whether Survodutide Helps Japanese People Living With Obesity Disease,' was posted on 2025-12-03 on clinicaltrials.gov.