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A Phase 3, Randomised, Double-blind, Parallel-group, 76-week, Efficacy and Safety Study of BI 456906 Administered Subcutaneously Compared With Placebo in Participants With Overweight or Obesity and Type 2 Diabetes Mellitus
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. The purpose of this study is to find out whether a medicine called survodutide (BI 456906) helps people living with overweight or obesity who also have diabetes 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 study staff also regularly measure participants' body weight. The results are compared between the groups to see whether the treatment works.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Pinnacle Research Group, LLC
Anniston, Alabama, United States
EmVenio Research-Atlanta-69582
Phoenix, Arizona, United States
Encompass Clinical Research, Spring Valley
Spring Valley, California, United States
Diablo Clinical Research
Walnut Creek, California, United States
Alliance for Multispecialty Research, LLC - Doral
Doral, Florida, United States
University of Florida
Gainesville, Florida, United States
East Coast Institute for Research, LLC - Jacksonville
Jacksonville, Florida, United States
New Horizon Research Center-Miami-69732
Miami, Florida, United States
West Orange Endocrinology
Ocoee, Florida, United States
Emory University
Atlanta, Georgia, United States
Start Date
November 27, 2023
Primary Completion Date
December 12, 2025
Completion Date
April 3, 2026
Last Updated
March 19, 2026
755
ACTUAL participants
Survodutide
COMBINATION_PRODUCT
Placebo
COMBINATION_PRODUCT
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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