A Study to Test Whether Survodutide (BI 456906) Helps People Living With Overweight or Obesity Wh… (NCT06066515) | Clinical Trial Compass
CompletedPhase 3
A Study to Test Whether Survodutide (BI 456906) Helps People Living With Overweight or Obesity Who do Not Have Diabetes to Lose Weight
United States, Australia, Belgium726 participantsStarted 2023-11-25
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male or female, age ≥18 years at the time of signing informed consent, and at least the legal age of consent in countries where it is \>18 years
. Body mass index (BMI) ≥30 kg/m\^2 at screening, OR BMI ≥27 kg/m\^2 with the presence of at least one of the obesity-related complications (treated or untreated) e.g,:
. History of at least one self-reported unsuccessful dietary effort to lose body weight.
Exclusion criteria
. Body weight change (self-reported) of \>5% within 3 months before screening.
. Treatment with any medication for the indication obesity within 3 months before screening.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage change in body weight from baseline to Week 76
Timeframe: Baseline and at Week 76
2
Achievement of body weight reduction ≥5% (yes/no) from baseline to Week 76
. Glycosylated haemoglobin A1c (HbA1c) ≥6.5% (≥48 mmol/mol) as measured by the central laboratory at screening.
. History of type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM) or treatment with glucose lowering agent started within 3 months before the screening up to and including the randomisation visit.
. Heart failure (HF) with New York Heart Association (NYHA) functional class IV.
. Known clinically significant gastric emptying abnormality (e.g. severe diabetic gastroparesis or gastric outlet obstruction).
. History of either chronic or acute pancreatitis or elevation of serum lipase or serum pancreatic amylase \>2x upper limit of normal (ULN) as measured by the central laboratory at screening.
. Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2).