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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1334-2043 | Registry Identifier | WHO International Clinical Trials Registry Platform (ICTRP) |
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Part 1:
To investigate safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of BI 3034701 in Japanese male and female participants with body mass index (BMI) ≥27.0 kg/m² or more following subcutaneous administration of multiple rising doses over 16 weeks.
Part 2:
To investigate safety, tolerability, and PK of BI 3034701 in Japanese male and female healthy participants with BMI ≥23.0 to <27.0 kg/m² following subcutaneous administration of multiple rising doses over 7 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 3034701 | Experimental | Part 1: multiple rising doses in participants with BMI ≥27.0 kg/m² or more Part 2: multiple rising doses in participants with BMI ≥23.0 to <27.0 kg/m² |
|
| Placebo | Placebo Comparator | Part 1: multiple rising doses in participants with BMI ≥27.0 kg/m² or more Part 2: multiple rising doses in participants with BMI ≥23.0 to <27.0 kg/m² |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 3034701 | Drug | BI 3034701 |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator | Expressed as the percentage of trial participants treated with investigational drug who experience such an event | Part 1: up to Week 19, Part 2: up to Week 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to 168 hours (AUC0-168) following a single dose and multiple doses of BI 3034701 | Part 1: up to Week 17, Part 2: up to Week 8 | |
| Maximum measured concentration of the analyte in plasma (Cmax) following a single dose and multiple doses of BI 3034701 |
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Inclusion criteria :
Exclusion criteria :
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim | Contact | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SOUSEIKAI Hakata Clinic | Fukuoka, Fukuoka | 812-0025 | Japan |
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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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| Drug |
Placebo |
|
| Part 1: up to Week 19, Part 2: up to Week 10 |
| Change from baseline in body weight at the end of 16 weeks treatment (only evaluated for Part 1) | Part 1: at Baseline and at Week 16 |
| Fukuoka Mirai Hospital | Fukuoka, Fukuoka | 813-0017 | Japan |
|
| SOUSEIKAI Sumida Hospital | Tokyo, Sumida-ku | 130-0004 | Japan |
|
| 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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