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About
This study is open to adults with obesity. People with a body mass index (BMI) in the range from 30 to 40 kg/m2 and a body weight of 70 to 150 kg can participate in the study. The purpose of this study is to find out whether treatment with a medicine called BI 456906 changes the occupancy of receptors in the liver and in the pancreas. These receptors are involved in appetite and weight regulation. To measure the occupancy of these receptors, doctors use injectable tracers. Doctors visualise the binding of the tracers to these receptors with imaging methods.
Participants are put into 4 groups randomly, which means by chance. 2 groups get BI 456906 and 2 groups get semaglutide. Semaglutide is an approved medicine for body weight reduction. For 17 weeks, participants get injections under the skin. They either get BI 456906 twice a week or semaglutide once a week. The injected doses increase in small steps. Before and after 17 weeks of treatment, the receptor occupancy is determined.
Participants are in the study for up to 6 months. At the beginning and at the end of the treatment participants stay at the study site with an overnight stay. At the beginning, the study staff trains participants how to inject the study treatment at home. Participants who get BI 456906 visit the study site 18 times and have 19 visits at home. Participants who get semaglutide visit the study site 15 times and have 6 home visits. The doctors also regularly check participants' health and take note of any unwanted effects.
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Inclusion criteria
Exclusion criteria
Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
Resting heart rate > 100 beats per minute (bpm) and/or systolic blood pressure ≥ 160 millimetre of mercury (mmHg) and/or diastolic blood pressure ≥95 mmHg at screening.
Any laboratory value outside the reference range that the investigator considers to be of clinical relevance. Subjects with the following abnormal values are not eligible for the trial participation:
Any evidence of a concomitant disease assessed as clinically relevant by the investigator. Subjects with type 1 and type 2 diabetes mellitus are not eligible for the trial
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders assessed as clinically relevant by the investigator
Diseases of the central nervous system (including but not limited to any kind of seizures), and other relevant neurological or psychiatric disorders
History of relevant orthostatic hypotension, fainting spells, or blackouts
Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2, manifest hypo- or hyperthyroidism at Visit 1
Further criteria apply
Primary purpose
Allocation
Interventional model
Masking
30 participants in 4 patient groups
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Central trial contact
Boehringer Ingelheim
Data sourced from clinicaltrials.gov
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