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A Phase III, Randomised, Double-blind, Parallel-group, 76-week, Efficacy and Safety Study of Survodutide Administered Subcutaneously Compared With Placebo in Patients With Obesity Disease in Japanese
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Hosokawa Surgery Clinic
Aichi, Nagoya, Japan
Nagoya City University Hospital
Aichi, Nagoya, Japan
Chiba University Hospital
Chiba, Chiba, Japan
Gifu University Hospital
Gifu, Gifu, Japan
Jiyugaoka Yamada Clinic
Hokkaido, Obihiro, Japan
Yamasaki Family Clinic
Hyogo, Amagasaki, Japan
Kobe University Hospital
Hyogo, Kobe, Japan
Motomachi Takatsuka Naika Clinic
Kanagawa, Yokohama, Japan
Morinagaueno Clinic
Kumamoto, Kumamoto, Japan
Yoshimura Clinic
Kumamoto, Kumamoto, Japan
Start Date
January 16, 2024
Primary Completion Date
December 3, 2025
Completion Date
December 3, 2025
Last Updated
December 12, 2025
274
ACTUAL participants
Survodutide
DRUG
Placebo matching survodutide
DRUG
Lead Sponsor
Boehringer Ingelheim
NCT01143454
NCT07472881
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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