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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1314-3577 | Registry Identifier | WHO - International Clinical Trials Registry Platform (ICTRP) | |
| 2024-519614-30-00 | Registry Identifier | CTIS (EU) |
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The goal of this study is to find out whether different formulations of survodutide given by different delivery methods is taken up in the body in a similar way.
Participants visit the study site regularly. During study visits, the doctors collect information about participants' health. To assess the study endpoints, participants regularly have blood samples taken.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Survodutide formulation A then Survodutide formulation B2 | Experimental | Survodutide formulation A = Reference treatment Survodutide formulation B2 = Test treatment |
|
| Survodutide formulation B2 then Survodutide formulation A | Experimental | Survodutide formulation A = Reference treatment Survodutide formulation B2 = Test treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Survodutide formulation A | Combination Product | Pre-filled syringe |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) | Up to Day 22 | |
| Maximum measured concentration of the analyte in plasma (Cmax) | Up to Day 22 | |
| Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) | Up to Day 22 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Humanpharmakologisches Zentrum Biberach | Biberach | 88397 | Germany |
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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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|
| Survodutide formulation B2 | Combination Product | Pre-filled pen |
|
|
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000726451 | BI 456906 |
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