Obesity Clinical Trial
Official title:
Open-label, Single Centre, Randomised, 3 Parallel-groups, Phase I Clinical Trial to Investigate BI 456906 Occupancy of Glucagon Receptors in Liver and Glucagon-like Peptide 1 Receptors in Pancreas in Comparison With Liraglutide After Administration of Radiolabeled Tracer in Subjects With Obesity Using 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 density 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 liraglutide. Liraglutide is an approved medicine for body weight reduction. For 14 weeks, participants get as injections BI 456906 two times a week or liraglutide daily. The doses of BI 456906 and liraglutide get higher over time. After 14 weeks of treatment, the receptor density in the liver, as well as in pancreas is compared between different groups. For group 2, doctors look at the receptor density in the brain. To do so, doctors label the receptors and visualise them with an imaging method (PET/CT scans). Participants are in the study for about 22 weeks. Depending on the group, they visit the study site 13 to 20 times. And 4 or 5 visits 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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| NCT number | NCT05202353 |
| Study type | Interventional |
| Source | Boehringer Ingelheim |
| Contact | Boehringer Ingelheim |
| Phone | 1-800-243-0127 |
| [email protected] | |
| Status | Not yet recruiting |
| Phase | Phase 1 |
| Start date | February 15, 2023 |
| Completion date | April 18, 2024 |
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