Actively Recruiting
A Study in People With Obesity to Test the Effects of BI 456906 Compared With Semaglutide on Glucagon Receptor Activity in the Liver
Led by Boehringer Ingelheim · Updated on 2026-04-14
30
Participants Needed
1
Research Sites
113 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
A Study in People With Obesity to Test the Effects of BI 456906 Compared With Semaglutide on Glucagon Receptor Activity in the Liver
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy male or female subjects as confirmed by medical history, physical exam, vital signs, ECG, and lab tests
- Aged 18 to 65 years (inclusive)
- Body mass index (BMI) between 30 and 40 kg/m2
- Body weight between 70 and 150 kg
- Signed informed consent before joining the study
- Women of childbearing potential must use two effective forms of birth control
You will not qualify if you...
- Any clinically relevant abnormal findings in medical exam, including blood pressure, pulse rate, or ECG
- Resting heart rate greater than 100 beats per minute
- Systolic blood pressure 160 mmHg or higher and/or diastolic blood pressure 95 mmHg or higher at screening
- Abnormal lab values considered clinically relevant, including LDL cholesterol over 160 mg/dL, total cholesterol over 240 mg/dL, triglycerides over 200 mg/dL, fasting blood glucose over 126 mg/dL, or HbA1c over 6.5%
- Diagnosis of type 1 or type 2 diabetes mellitus
- Significant gastrointestinal, liver, kidney, lung, heart, metabolic, immune, or hormone disorders
- Central nervous system diseases or major neurological or psychiatric disorders
- History of orthostatic hypotension, fainting, or blackouts
- Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2
- Manifest hypo- or hyperthyroidism at first visit
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Amsterdam UMC, location VUMC
Amsterdam, Netherlands, 1105 AZ
Actively Recruiting
Research Team
B
Boehringer Ingelheim
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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