A Study in People With Obesity to Test the Effects of BI 456906 Compared With Semaglutide on Glucagon Receptor Activity in the Liver
- Conditions
- Obesity
- Registration Number
- NCT05202353
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - Healthy male or female subjects according to the assessment of the investigator, as<br> based on a complete medical history including a physical examination, vital signs<br> (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and<br> clinical laboratory tests<br><br> - Age of 18 to 65 years (inclusive)<br><br> - Body mass index (BMI) of = 30 and = 40 kg/m2 and body weight =70 kg and =150 kg<br><br> - Signed and dated written informed consent prior to admission to the study, in<br> accordance with Good Clinical Practice (GCP) and local legislation<br><br> - Women of childbearing potential (WOCBP) must be willing and able to use two forms of<br> effective contraception where at least one form is a highly effective method of<br> birth control per International Council for Harmonisation (ICH) M3 (R2) that result<br> in a low failure rate of less than 1% per year when used consistently and correctly<br><br>Exclusion Criteria:<br><br> - Any finding in the medical examination (including BP, PR or ECG) deviating from<br> normal and assessed as clinically relevant by the investigator<br><br> - Resting heart rate > 100 beats per minute (bpm) and/or systolic blood pressure = 160<br> millimetre of mercury (mmHg) and/or diastolic blood pressure =95 mmHg at screening.<br><br> - Any laboratory value outside the reference range that the investigator considers to<br> be of clinical relevance. Subjects with the following abnormal values are not<br> eligible for the trial participation:<br><br> - Low-density lipoprotein (LDL) > 160 mg/dL (4.15 mmol/L)<br><br> - total cholesterol >240 mg/dL (6.22 mmol/L)<br><br> - triglyceride >200 mg/dL (2.26 mmol/L)<br><br> - blood glucose > 126 mg/dl (7 mmol/L) fasting and/or glycated haemoglobin<br> (HbA1c) >6.5%<br><br> - Any evidence of a concomitant disease assessed as clinically relevant by the<br> investigator. Subjects with type 1 and type 2 diabetes mellitus are not eligible for<br> the trial<br><br> - Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,<br> immunological or hormonal disorders assessed as clinically relevant by the<br> investigator<br><br> - Diseases of the central nervous system (including but not limited to any kind of<br> seizures), and other relevant neurological or psychiatric disorders<br><br> - History of relevant orthostatic hypotension, fainting spells, or blackouts<br><br> - Personal or family history of medullary thyroid carcinoma or multiple endocrine<br> neoplasia syndrome type 2, manifest hypo- or hyperthyroidism at Visit 1<br><br>Further criteria apply
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of glucagon (GCG) receptors occupancy in the liver using Positron emission tomography (PET) imaging at End of Treatment (EOT) visit
- Secondary Outcome Measures
Name Time Method Percentage of glucagon-like Peptide 1 (GLP-1) receptors occupancy in the pancreas using PET imaging at EOT visit