Overview

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

Status:
Completed
Trial end date:
2020-04-30
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Boehringer Ingelheim
Criteria
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