Obesity
Conditions
Brief summary
Main objective is to investigate the tolerability of different titration schemes of BI 456906 in otherwise healthy patients with obesity/overweight, and to determine a titration scheme for future studies.
Interventions
DRUGBI 456906
Solution for injection
DRUGPlacebo
solution for injection
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Male and female patients ≥ 18 years and \< 70 years of age at screening * Body Mass Index (BMI) ≥ 27 kg/m2 and \<40 kg/m2 at screening * A minimum absolute body weight of 70 kg at screening and a stable body weight (defined as no more than 5% change) 3 months prior to screening * HbA1c \<6.5% * Further inclusion criteria apply
Exclusion criteria
* Women who are pregnant, nursing, or who plan to become pregnant while in the trial * Supine blood pressure (BP) ≥160/100 mmHg at screening * Major surgery (major according to the investigator's assessment) performed within 12 weeks prior to randomization or planned within 12 months after screening * Any laboratory value outside the reference range that the investigator considers to be of clinical relevance * Further
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cumulative number [N (%)] of patients withdrawn from up-titration by up-titration scheme | Up to 132 days |
Secondary
| Measure | Time frame |
|---|---|
| AUC0-168 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 168h) | Up to 168 hours |
| Cmax (maximum measured concentration of the analyte in plasma) after first dose | Up to 132 days |
Countries
Germany
Outcome results
None listed