A Study to Test Different Doses of BI 456906 in Patients With Obesity

A Phase I, Blinded Within Dose Groups, Multiple Dose, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Different Titration Schemes of BI 456906 in Patients With Obesity and Overweight.

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.

AUC0-168 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 168h)

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 exclusion criteria apply

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