A Study to Test Whether Survodutide Helps Japanese People Living With Obesity Disease
Status:
Active, not recruiting
Trial end date:
2026-02-02
Target enrollment:
Participant gender:
Summary
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.
People who have either type 2 diabetes, high blood pressure, or increased blood lipids can
take part in this study. Only people who have previously not managed to lose weight by
changing their diet can participate.
The purpose of this study is to find out whether a medicine called survodutide (BI 456906)
helps people living with obesity disease to lose weight. Participants are divided into 3
groups by chance, like drawing names from a hat. 2 groups get different doses of survodutide
and 1 group gets placebo. Placebo looks like survodutide but does not contain any medicine.
Every participant has a 2 in 3 chance of getting survodutide. Participants inject survodutide
or placebo under their skin once a week for about one and a half years. In addition to the
study medicine, all participants receive counselling to make changes to their diet and to
exercise regularly.
Participants are in the study for about 1 year and 7 months. During this time, it is planned
that participants visit the study site up to 14 times and receive 6 phone calls by the site
staff.
The doctors check participants' health and take note of any unwanted effects. The
participants' body weight is regularly measured. The results are compared between the groups
to see whether the treatment works.