A Study to Test Whether Survodutide (BI 456906) Helps People Living With Overweight or Obesity Who do Not 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 (BMI) of 30 kg/m² or more, or * a BMI of 27 kg/m² or more and at least one health problem related to their weight.

People with type 2 diabetes cannot take part in this study.

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

726 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) ≥30 kg/m\^2 at screening, OR BMI ≥27 kg/m\^2 with the presence of at least one of the obesity-related complications (treated or untreated) e.g,:. Obstructive sleep apnoea. History of at least one self-reported unsuccessful dietary effort to lose body weight.

The full record lists 7 inclusion and 8 exclusion criteria; among the exclusions: treatment with any medication for the indication obesity within 3 months before screening; heart failure (hf) with new york heart association (nyha) functional class iv; personal or family history of medullary thyroid carcinoma (mtc) or multiple endocrine neoplasia syndrome type 2 (men 2).

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

The participants were allocated by chance, so the Survodutide group and the comparison group should start out alike.

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

As a double-blind Survodutide study, the assignments were hidden from both participants and investigators until the end.

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

It started in 2023-11-25 with completion listed for 2025-12-02.

It ran at 118 sites in United States (32), China (19), Canada (10), South Korea (10), Australia (7) and United Kingdom (6).

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 31 secondary outcomes, for example Absolute change from baseline to Week 76 in body weight (kg), 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 the Eating Behaviour patient reported outcome (PRO), Absolute change from baseline to Week 76 in Eating Behaviour PRO total score and Absolute change from baseline to Week 76 in body mass index (BMI) (kg/m2).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Survodutide in 726 people.

With 726 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.