Survodutide
Combination Productonce weekly subcutaneous injection, pre-filled syringe
Other names: BI 456906
NCT Number: NCT06066528
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 3
Nepean Hospital, Kingswood, New South Wales, Australia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Further exclusion criteria apply.
once weekly subcutaneous injection, pre-filled syringe
Other names: BI 456906
once weekly subcutaneous injection, pre-filled syringe
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
"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
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 and Type 2 Diabetes Mellitus
Acronym: SYNCHRONIZE™-2
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.
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