Obesity, Overweight
Conditions
Brief summary
This study is open to adults with overweight or obesity who are otherwise healthy. People can join the study if they have a body mass index of 27 to 39.9 kg/m2 and a body weight over 70 kg. The purpose of this study is to find out whether taking multiple doses of BI 456906 influences the amount of bupropion, caffeine, and midazolam in the blood. The study has 2 treatment periods. In Period 1, participants take 1 dose each of midazolam, caffeine, and bupropion as tablets or oral solution on separate days. In Period 2, participants get BI 456906 as an injection under the skin once a week. At 2 selected timepoints in Period 2, participants also take midazolam, caffeine and bupropion as tablets or oral solution on separate days. Participants are in the study for about 13 months. They visit the study site up to 45 times. At 3 of those visits, participants stay for 5 or 6 days at the study site. During the visits, doctors collect information about participants' health and take blood samples from the participants. They compare the amounts of midazolam, caffeine, and bupropion in the blood in Period 2 with the amounts in Period 1. Doctors also regularly check participants' health and take note of any unwanted effects.
Interventions
COMBINATION_PRODUCTSurvodutide
Survodutide, pre-filled syringe
DRUGBupropion
Bupropion
DRUGCaffeine
Caffeine
DRUGMidazolam
Midazolam
Sponsors
Boehringer Ingelheim
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The trial consists of two periods in a fixed sequence: period 1 (reference treatment) followed by period 2 (test treatment) within the BI 456906 titration scheme.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
: 1. Otherwise 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 (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests 2. Age of 18 to 60 years (inclusive) at signing of informed consent 3. Body mass index (BMI) of 27.0 to 39.9 kg/m² (inclusive) and body weight \> 70 kg 4. Signed and dated written informed consent in accordance with International Council for Harmonisation - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial, i.e. prior to starting any screening procedures legislation prior to admission to the trial, i.e. prior to starting any screening procedures 5. Further inclusion criteria apply
Exclusion criteria
: 1. Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator. 2. Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimetre of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 beats per minute (bpm) 3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance and in particular: * Alanine aminotransferase (ALT) above upper limit of normal (ULN) + 20%, * Aspartate aminotransferase (AST) above ULN + 20%, * Gamma-Glutamyl-Transferase (GGT) above ULN + 20%, * Lipase or amylase above ULN + 20%, * Estimated glomerular filtration rate (eGFR) \< 80 mL/min/1.73 m². 4. Any evidence of a concomitant disease assessed as clinically relevant by the investigator 5. Further
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the concentration-time curve of bupropion in plasma over the time interval from 0 extrapolated to infinity (AUC 0-∞) | Up to week 32 |
| Area under the concentration-time curve of the caffeine in plasma over the time interval from 0 extrapolated to infinity (AUC 0-∞) | Up to week 32 |
| Area under the concentration-time curve of midazolam in plasma over the time interval from 0 extrapolated to infinity (AUC 0-∞) | Up to week 32 |
| Maximum measured concentration of bupropion in plasma (Cmax) | Up to week 32 |
| Maximum measured concentration of caffeine in plasma (Cmax) | Up to week 32 |
| Maximum measured concentration of midazolam in plasma (Cmax) | Up to week 32 |
Countries
Belgium
Outcome results
None listed