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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-000327-13 | EudraCT Number |
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The main objective of this trial is to investigate safety, tolerability and pharmacokinetics (PK) and pharmacodynamics (PD) of BI 1820237 alone or together with a single low dose of liraglutide in male subjects with overweight/obesity (otherwise healthy) following subcutaneous administration of single rising doses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 1820237 | Experimental | Part 1 and part 2 of the trial. |
|
| Placebo | Placebo Comparator | Part 1 and part 2 of the trial. |
|
| BI 1820237 + liraglutide | Experimental | Part 3 of the trial. |
|
| Placebo + liraglutide | Placebo Comparator | Part 3 of the trial. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 1820237 | Drug | BI 1820237 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects with drug-related adverse events | up to 48 days |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) | up to 38 days | |
| Maximum measured concentration of the analyte in plasma (Cmax) | up to 38 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CRS Clinical Research Services Mannheim GmbH | Mannheim | 68167 | 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, except for the following exclusions:
For more details refer to: https://www.mystudywindow.com/msw/datasharing
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Within the central electrocardiogram (ECG) lab, the staff involved with interval measurements will be blinded with respect to the treatment and also with regard to the recording date and time as well as planned time points of the ECGs. The interval measurements for a given subject will be performed in a random and blinded sequence by a single technician.
| Placebo |
| Drug |
Placebo |
|
| Saxenda® | Drug | Saxenda® |
|
|
| Paracetamol-ratiopharm® | Drug | Paracetamol-ratiopharm® |
|
|
| ID | Term |
|---|---|
| D000069450 | Liraglutide |
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D052216 | Glucagon-Like Peptide 1 |
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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