obesity being overweight Obesity
Conditions
Interventions
See the study design
Sponsors
Boehringer Ingelheim
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Healthy male or female subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests 2. Age of 18 to 65 years (inclusive) 3. BMI of >=30 and =70 kg and
Exclusion criteria
Exclusion criteria: Subjects will not be allowed to participate if any of the following general criteria apply: 1. Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator 2. Resting heart rate >100 beats per minute (bpm) and/or systolic blood pressure >=160 mmHg and/or diastolic blood pressure >=95 mmHg at screening 3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance. Subjects with the following abnormal values are not eligible for the trial participation: - LDL >160 mg/dL (4.15 mmol/L) - total cholesterol >240 mg/dL (6.22 mmol/L) - triglyceride >200 mg/dL (2.26 mmol/L) - blood glucose >126 mg/dl (7 mmol/L) fasting and/or HbA1c >6.5% 4. Any evidence of a concomitant disease assessed as clinically relevant by the investigator. Subjects with type 1 and type 2 diabetes mellitus are not eligible for the trial 5. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders assessed as clinically relevant by the investigator 6. Diseases of the central nervous system (including but not limited to any kind of seizures), and other relevant neurological or psychiatric disorders 7. History of relevant orthostatic hypotension, fainting spells, or blackouts 8. Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2, manifest hypo- or hyperthyroidism at Visit 1 9. Calcitonin >=100 pg/mL (29.26 pmol/L) at screening 10. Any suicidal behaviour or history of major depressive disorder requiring inpatient treatment or escalation of care in the past 2 years before randomization, any suicidal ideation of type 4 or 5 in the C-SSRS in the past 3 months prior to Visit 1 11. Chronic or relevant acute infections 12. History of chronic or acute pancreatitis or elevation of serum lipase/amylase >2x ULN 13. History of relevant allergy or hypersensitivity (including allergy to the trial medication or its excipients) according to investigator's assessment 14. Use of prescription or over-the counter drugs within 30 days of planned administration of trial medication that might reasonably influence the results of the trial including drugs known to significantly prolong the QT/QTcF interval; please refer to Section 4.2.2 15. Intake of an investigational drug in another clinical trial within 60 d of planned administration of investigational drug in the current trial, or concurrent participation in another clinical trial in which investigational drug is administered 16. Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day) and inability to refrain from smoking on specified trial days 17. Ongoing chronic alcohol use or drug abuse other than the ones described in Table 5.2.3: 2, that in the investigator*s opinion, makes the subject an unreliable trial subject or unlikely to complete the trial 18. Blood donation of more than 500 mL within 30 d of planned administration of trial medication or intended blood donation during the trial 19. Intention to perform excessive physical activities within one week prior to the administration of trial medication or during the trial 20. Inability to comply with the dietary regimen of the trial site 21. A marked baseline p
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint: · Percentage of glucagon receptors occupancy in the liver using PET imaging at End of Treatment visit (EOT). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secundary endpoints: · Percentage of glucagon-like Peptide 1 receptor occupancy in the pancreas using PET imaging at EOT visit. | — |
Countries
Netherlands
Outcome results
None listed