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

Boehringer Ingelheim

Status and phase

Completed

Phase 1

Conditions

Obesity

Treatments

Drug: BI 456906

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT03591718

1404-0003

2018-000250-22 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

131 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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