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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-000250-22 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 456906 | Experimental |
| |
| Placebo | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 456906 | Drug | Solution for injection |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative number [N (%)] of patients withdrawn from up-titration by up-titration scheme | Up to 132 days |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-168 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 168h) | Up to 168 hours | |
| Cmax (maximum measured concentration of the analyte in plasma) after first dose | Up to 132 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Profil Mainz GmbH & Co. KG | Mainz | 55116 | Germany | |||
| Profil Institut für Stoffwechselforschung GmbH |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36527386 | Derived | Jungnik A, Arrubla Martinez J, Plum-Morschel L, Kapitza C, Lamers D, Thamer C, Scholch C, Desch M, Hennige AM. Phase I studies of the safety, tolerability, pharmacokinetics and pharmacodynamics of the dual glucagon receptor/glucagon-like peptide-1 receptor agonist BI 456906. Diabetes Obes Metab. 2023 Apr;25(4):1011-1023. doi: 10.1111/dom.14948. Epub 2023 Jan 30. |
| Label | URL |
|---|---|
| Related Info | View source |
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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'.
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C000726451 | BI 456906 |
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| Drug |
solution for injection |
|
| Neuss |
| 41460 |
| Germany |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |