Trial · Interventional
Active, not recruitingPhase 1Registry dataA Study in People With Obesity to Test the Effects of BI 456906 Compared With Semaglutide on Glucagon Receptor Activity in the Liver
Overview
- Status
- Active, not recruiting
- Phase
- Phase 1
- Enrollment
- 29 participants (actual)
- Sponsor
- Boehringer Ingelheim · Industry
- Design
- Randomized · Single masking
- Countries
1 country
Netherlands
- Start
- 1 Nov 2024
- Primary completion
- 6 Jan 2027 (estimated)
- Completion
- 3 Feb 2027 (estimated)
- First posted
- 21 Jan 2022
- Last update posted
- 9 Sept 2026
- Conditions
- Obesity
Timeline
1 trial · 1 ongoing
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 1
A Study in People With Obesity to Test the Effects of BI 456906 Compared With Semaglutide on Glucagon Receptor Activity in the Liver
NCT052023531 Nov 2024 to est. 3 Feb 2027
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- BI 456906Drug
- SemaglutideDrug
Arms4
Experimental
Group 1: BI 456906
PET/CT imaging for analysis of the liver
Experimental
Group 2: Semaglutide
PET/CT imaging for analysis of the liver
Active comparator
Group 3: BI 456906
PET/CT imaging for analysis of the pancreas
Active comparator
Group 4: Semaglutide
PET/CT imaging for analysis of the pancreas
Primary outcomes1
Outcomes the sponsor listed as primary.
Percentage of glucagon (GCG) receptors occupancy in the liver using Positron emission tomography (PET) imaging at End of Treatment (EOT) visit
Time frame · up to Week 17
Secondary outcomes(1)
Percentage of glucagon-like Peptide 1 (GLP-1) receptors occupancy in the pancreas using PET imaging at EOT visit
Time frame · up to Week 17
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
A trial that is still running, or that stopped early, may post results later.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 65 Years
- Healthy volunteers
- Accepted
Inclusion and exclusion criteria, as posted
PepBank is a research reference. Talk to a doctor before you use any peptide.