A Study to Test Whether Survodutide (BI 456906) Helps People Living With Overweight or Obesity Who Also Have Diabetes to Lose Weight

What Was Tested

In this phase 3 trial, researchers set out to test Survodutide.

This study is open to adults who are at least 18 years old and have a body mass index of 27 kg/m² or more.

People can take part if they have type 2 diabetes and if they are currently being treated only with diet and exercise or with specific diabetes medications.

Only people who have previously not managed to lose weight by changing their diet can participate.

It had three arms (groups): one (experimental), one (experimental) and Placebo (placebo comparator).

The registry classes the interventions as combination product.

Who Took Part

755 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: Male or female, 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. Body mass index (BMI) ≥27 kg/m\^2 at screening. Currently treated for T2DM with either diet and exercise alone or stable treatment (for at least 3 months prior to screening) per treatment guidelines. History of at least one self-reported unsuccessful dietary effort to lose body weight Further inclusion criteria apply.

The full record lists 6 inclusion and 6 exclusion criteria; among the exclusions: treatment with any medication for the indication obesity within 3 months before screening; personal or family history of medullary thyroid carcinoma (mtc) or multiple endocrine neoplasia syndrome type 2 (men 2).

How the Study Was Run

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

Because people in this Survodutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Survodutide group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received Survodutide.

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

It started in 2023-11-27 with completion listed for 2025-12-12.

It ran at 143 sites in United States (34), China (20), Canada (11), South Korea (9), Australia (8) and Spain (7).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Percentage change in body weight from baseline to Week 76 (time frame: Baseline and at Week 76).

It also tracked 22 secondary outcomes, for example Absolute change from baseline to Week 76 in body weight (kg), Absolute change from baseline to Week 76 in glycosylated haemoglobin A1c (HbA1c) (%), Absolute change from baseline to Week 76 in waist circumference (cm), Absolute change from baseline to Week 76 in systolic blood pressure (SBP) (mmHg), Absolute change from baseline to Week 76 in "Capacity to Resist" domain score of Eating Behaviour patient reported outcome (PRO) and Key secondary endpoint: Absolute change from baseline to Week 76 in Eating Behaviour PRO total score.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Survodutide in 755 people.

With 755 participants it is a large trial for this field.

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.