A Study to Test Whether Survodutide Helps Japanese People Living With Obesity Disease

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 35 kg/m² or more and at least one health problem related to their weight, or * a BMI of 27 kg/m² or more and at least two health problems related to their weight.

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 group (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 274 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. Body Mass Index (BMI). ≥35 kg/m² at screening with the presence of at least one obesity-related comorbidities (treated or untreated) according to the Japan Society for the Study of Obesity (JASSO) guideline OR. History of at least one self-reported unsuccessful dietary effort to lose body weight. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.

The full record lists 14 inclusion and 8 exclusion criteria; among the exclusions: treatment with any medication for the indication obesity within 3 months before screening; history of t1dm or t2dm or treatment with glucose lowering agent started within 3 months before screening; history of t1dm.

How the Study Was Run

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

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.

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 2024-01-16 with completion listed for 2025-12-03.

It ran at 28 sites in Japan (28).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Percentage change in body weight from baseline to Week 76 (time frame: at baseline, at week 76).

It also tracked 34 secondary outcomes, for example Absolute change from baseline to Week 76 in body weight (kg), Absolute change from baseline to Week 76 in body mass index (BMI) (kg/m²), Absolute change from baseline to Week 76 in waist circumference measured at umbilical level (cm), Absolute change from baseline to Week 76 in waist circumference measured at midway between the lower rib margin and the iliac crest (cm), Absolute change from baseline to Week 76 in systolic blood pressure (SBP) (mmHg) and Absolute change from baseline to Week 76 in diastolic blood pressure (DBP) (mmHg).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Survodutide in 274 people.

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.