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