A Study to Test Different Doses of BI 456906 in Patients With Obesity
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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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.
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.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years to 70 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Male 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.
Further inclusion criteria apply
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
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions: 1. Studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. Studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). Requestors can use the following link http:// trials.boehringer-ingelheim.com/ to: 1.find information in order to request access to clinical study data, for listed studies. 2.request access to clinical study documents that meet criteria, and upon a signed 'Document Sharing Agreement'.