A Study in People With Obesity to Test the Effects of Different Doses of BI 456906 Compared With Liraglutide on Glucagon Receptor Activity in the Liver

• Status: Not yet recruiting
• Trial end date: 2023-05-12

Summary

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.

• Phase: Phase 1

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Liraglutide