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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-522325-35-00 | EU Trial (CTIS) Number | ||
| U1111-1322-4700 | Registry Identifier | WHO - International Clinical Trials Registry Platform (ICTRP) |
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This study is open to healthy people between 18 and 65 years of age. People can join the study if they have a body mass index between 27 and 39.9 kg/m2.
The purpose of this study is to test a new formulation of a medicine called survodutide. Survodutide is being developed to help people with obesity and people with liver conditions. When a new formulation is developed, it is important to understand how it is taken up by the body.
Participants are divided into 2 groups by chance. One group gets the reference formulation of survodutide (formulation A). The other group gets the new formulation of survodutide (formulation B2). Participants in both groups inject survodutide under their skin once a week for about 6 and a half months.
Participants are in the study for about 7 months. During this time, they visit the study site 15 times. For one of the visits, participants stay overnight for 3 nights at the study site. The site staff takes blood samples to measure how much survodutide is in the blood. They also check participants' health and take note of any unwanted effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| survodutide formulation A (reference treatment) | Active Comparator |
| |
| survodutide formulation B2 (test treatment) | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| survodutide | Combination Product | survodutide, pre-filled syringe |
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| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval Ï„ (AUCÏ„,ss) | up to 232 days | |
| Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval Ï„ (Cmax,ss) | up to 232 days |
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Inclusion criteria:
Exclusion criteria:
Further exclusion criteria apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CRS Clinical Research Services Berlin GmbH | Berlin | 13627 | Germany | |||
| CRS Clinical Research Services Mannheim GmbH |
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| 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. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).
For more details refer to:
https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing
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| Mannheim |
| 68167 |
| Germany |