Albion Finch Medical Centre | Clinical Practice of Family Medicine
Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
About
This study is open to adults who are at least 18 years old and have
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.
Enrollment
Sex
Ages
Volunteers
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.
Further inclusion criteria apply.
Exclusion criteria
Further exclusion criteria apply.
Primary purpose
Allocation
Interventional model
Masking
727 participants in 3 patient groups, including a placebo group
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Central trial contact
Boehringer Ingelheim
Data sourced from clinicaltrials.gov
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