Survodutide
Combination Productonce weekly subcutaneous injection
Other names: BI 456906
NCT Number: NCT06066515
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.
The purpose of this study is to find out whether a medicine called survodutide (BI 456906) helps people living with overweight or obesity 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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Phase 3
Hunter Diabetes Centre, Merewether, New South Wales, Australia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Further inclusion criteria apply.
Exclusion criteria
Further exclusion criteria apply.
once weekly subcutaneous injection
Other names: BI 456906
once weekly subcutaneous injection
Time frame: Baseline and at Week 76
Time frame: Baseline and at Week 76
Time frame: Baseline and at Week 76
Time frame: Baseline and at Week 76
Time frame: Baseline and at Week 76
Time frame: Baseline and Week 76
Time frame: Baseline and at Week 76
Time frame: Baseline and at Week 76
Time frame: Baseline and at Week 76
"Capacity to Resist" domain score of the Eating Behaviour PRO is ranging between 0 and 24 and a higher score indicates a lower capacity to resist.
Time frame: Baseline and at Week 76
Eating Behaviour PRO total score is ranging between 0 and 48 and a higher score indicates a worse eating behaviour (greater desire to eat and/or lower capacity to resist).
Time frame: Baseline and at Week 76
Time frame: Baseline and at Week 76
Time frame: Baseline and at Week 76
Time frame: Baseline and at Week 76
Time frame: Baseline and at Week 76
Time frame: Baseline and at Week 76
Time frame: Baseline and at Week 76
Time frame: Baseline and at Week 76
Time frame: Baseline and at Week 76
Time frame: Baseline and at Week 76
Time frame: Baseline and at Week 76
Time frame: Baseline and at Week 76
Time frame: Baseline and at Week 76
Time frame: Baseline and at Week 76
Time frame: Baseline and at Week 76
Time frame: Baseline and at Week 76
Time frame: Baseline and at Week 76
Time frame: Baseline and at Week 76.
Time frame: Baseline and at Week 76
Time frame: Baseline and at Week 76
Time frame: Baseline and at Week 76
Time frame: Baseline and at Week 76.
Time frame: Baseline and at Week 76
Boehringer Ingelheim
Industry
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 Without Type 2 Diabetes
Acronym: SYNCHRONIZE™-1
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05742165
Behavior, Body Weight
New York, United States
View Trial DetailsNCT05882045
Body Weight, Cardiovascular Diseases
Phoenix, Arizona, United States
View Trial DetailsNCT05929079
Apnea, Body Weight
Anniston, Alabama, United States
View Trial DetailsNCT00342732
Body Weight, Nutrition Disorders
Phoenix, Arizona, United States
View Trial Details