Obesity
Conditions
Interventions
Participants will be randomly assigned to one of the 4 active dose arms of BI
456906 or placebo at a 1:1:1:1:1 ratio.
The different treatment arms and the dose escalation scheme are presented in
Tab
Sponsors
Boehringer Ingelheim
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Adult >= 18 years and =27 kg/m2 at screening 4. A minimum absolute body weight of 70 kg for females and 80 kg for males at screening 5. Male or female participants. Women of childbearing potential must be willing and able to use two forms of effective contraception 6. Patients must have undergone at least one previous unsuccessful nonsurgical weight-loss attempt per investigator*s judgement
Exclusion criteria
Exclusion criteria: 1. Body weight change of over +/- 5% or more in the past 12 weeks prior to randomization. There must be documentation of weight in the past 12 weeks before randomization. 2. Obesity induced by an endocrinologic disorder (e.g. Cushing Syndrome) 3. A HbA1c >= 6.5% at screening or diagnosed with type 1 or type 2 diabetes mellitus 4. Exposure to GLP-1Ra based therapies within three months prior to screening Further criteria apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Percentage change in body weight (%) from baseline to week 46 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are: - Weight loss of >= 5% of baseline weight at week 46 - Weight loss of >= 10% of baseline weight at week 46 - Weight loss of >= 15% of baseline weight at week 46 - Absolute change in body weight (kg) from baseline to week 46 - Absolute change in waist circumference (cm) from baseline to week 46 - Absolute change in systolic blood pressure (mmHg) from baseline to week 46 - Absolute change in diastolic blood pressure (mmHg) from baseline to week 46 | — |
Countries
Netherlands
Outcome results
None listed