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This study is open to Chinese adults aged 18 to 60 with overweight or obesity. People can join the study if they have a Body Mass Index from 24 to 40.0 kg/m2.
Survodutide is a medicine being developed to help people with overweight or obesity. The purpose of this study is to find out how different doses of survodutide are taken up in the body. Other goals are to test if participants can tolerate different doses of survodutide and whether survodutide helps people with overweight or obesity.
Participants receive survodutide as an injection under the skin once a week for 7.5 months. During this time, participants visit the study site 33 times. 4 of the visits require a stay in the hospital. At the visits, doctors take blood samples to measure the levels of survodutide in participants' blood. The doctors also check participants' health and take note of any unwanted effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Participants with a body mass index (BMI) ranging from ≥27.0 kg/m² to ≤40.0 kg/m² | Experimental |
| |
| Arm 2: Participants with a body mass index (BMI) ranging from ≥24.0 kg/m² to <27.0 kg/m² | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| survodutide | Drug | survodutide |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-168 (area under the concentration-time curve of survodutide in plasma over the time interval from 0 to 168h) | up to 7 days | |
| Cmax (maximum measured concentration of survodutide in plasma) after the first dose | up to 7 days | |
| Cmax (maximum measured concentration of survodutide in plasma) after multiple doses | up to 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage (%) of participants withdrawn due to adverse events from up-titration by dose | up to 7 days |
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Inclusion Criteria:
Chinese ethnicity
Age of 18 to 60 years
40≥ body mass index (BMI) ≥30 kilogram (kg)/ square meters (m²) at screening, or 30> BMI ≥27 kg/m² at screening with the presence of at least one of the following weight-related complications
stable body weight in the 3 months prior to screening visit (defined as no more than 5% change by self-report)
further inclusion criteria apply
Exclusion Criteria:
Repeated measurement of sitting blood pressure (BP) ≥160/95 millimeter of mercury (mmHg), or pulse rate (PR) >100 beats per minute (bpm) after 5 minutes of resting at screening visit.
Exposure to any glucagon-like-peptide 1 receptor (GLP-1R) agonist (including combination products) within three months prior to screening visit, or any previous exposure to survodutide, or history of relevant allergy or hypersensitivity (including allergy intolerability or lack of efficacy to trial medication or drugs that belongs to the GLP-1R agonist class).
Trial participants with the following laboratory findings at screening are excluded:
History of either chronic or acute pancreatitis or elevation of serum lipase or amylase >2x ULN as measured by the laboratory at screening
further exclusion criteria apply
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Central Hospital of Xuhui District | Shanghai | 200031 | China |
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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.mystudywindow.com/msw/datatransparency
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |