Obesity Clinical Trial
Official title:
Open-label,Randomised, 3 Parallel-group, Phase I Clinical Trial to Investigate BI 456906occupancy of Glucagon Receptorsin Liver and Glucagon-like Peptide 1receptors in Pancreas in Comparison With Semaglutide After Administration of Radiolabeled Tracer in Male and Female Subjectswith Obesityusing PET and MRI
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 kg or higher can join the study. The purpose of this study is to find out whether treatment with a medicine called BI 456906 changes the occupancy of the glucagon receptor in the liver. These receptors are involved in appetite and weight regulation. Participants are put into 3 groups randomly, which means by chance. Participants in groups 1 and 2 get BI 456906. Participants in group 3 get semaglutide. Semaglutide is an approved medicine for body weight reduction. For 17 weeks, participants get as injections BI 456906 two times a week or semaglutide once a week. The doses of BI 456906 and semaglutide get higher over time. After 17 weeks of treatment, the receptor occupancy in the liver, as well as in pancreas is compared between different groups. To do so, doctors label the receptors and visualise them with an imaging method (PET/CT scans). Participants are in the study for about 25 weeks. Depending on the group, they have 21 to 25 visits. And 5 to 7 visits of all are done at the participant's home. The doctors also regularly check participants' health and take note of any unwanted effects.
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