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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1335-5538 | Registry Identifier | WHO International Clinical Trials Registry Platform (ICTRP) |
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This study is open to adults between 18 and 74 years of age and who have a body mass index (BMI) of 30 kg/m2 or more, or a BMI of 27 kg/m2 or more and at least 1 health problem related to their weight. People who have previously not managed to lose weight by changing their diet can participate. People with type 2 diabetes cannot take part in this study.
The purpose of this study is to find out whether a medicine called BI 3034701 helps people living with obesity or overweight to lose weight. This study has 7 groups of participants. Groups 1 to 6 get different doses of BI 3034701; Group 7 gets placebo. Placebo looks like BI 3034701 but does not contain any medicine. Every participant has more than an 80% chance of getting BI 3034701. Participants receive 2 injections of BI 3034701 or placebo under their skin for 42 weeks. In addition to the study medicine, all participants receive counselling to make changes to their diet and to exercise regularly.
Participants are in the study for about 10 months. During this time, they visit the study site 15 times. The study doctors regularly measure the participants' body weight and take necessary laboratory tests. Participants also answer questions about their well-being and note their food intake and physical activity in diaries. The results will be compared between groups of participants to see whether the treatment works. The study doctors also regularly check participants' health and take note of any unwanted effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 3034701 treatment group 1 | Experimental |
| |
| BI 3034701 treatment group 2 | Experimental |
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| BI 3034701 treatment group 3 | Experimental |
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| BI 3034701 treatment group 4 | Experimental |
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| BI 3034701 treatment group 5 | Experimental |
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| BI 3034701 treatment group 6 | Experimental |
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| Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 3034701 | Drug | BI 3034701 |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage change in body weight from baseline at Week 42 [%] | Baseline and at Week 42. |
| Measure | Description | Time Frame |
|---|---|---|
| Achievement of weight loss of ≥5% of baseline weight at Week 42 | Baseline and at Week 42. | |
| Achievement of weight loss of ≥10% of baseline weight at Week 42 | Baseline and at Week 42. | |
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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 |
|---|---|---|---|---|---|---|
| Cahaba Research, Inc. - Trussville Location | Recruiting | Birmingham | Alabama | 35235 | United States |
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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
One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.
For study documents -upon signing of a 'Document Sharing Agreement'. For study data -1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.
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| Placebo matching BI 3034701 | Drug | Placebo matching BI 3034701 |
|
| Achievement of weight loss of ≥15% of baseline weight at Week 42 |
| Baseline and at Week 42. |
| Achievement of weight loss of ≥20% of baseline weight at Week 42 | Baseline and at Week 42. |
| Absolute change from baseline at Week 42 in body weight [kg] | Baseline and at Week 42. |
| Absolute change from baseline at Week 42 in waist circumference [cm] | Baseline and at Week 42. |
| Absolute change from baseline at Week 42 in waist-to-height ratio (WHtR) [dimensionless ratio] | Baseline and at Week 42. |
| Absolute change from baseline at Week 42 in systolic blood pressure (SBP) [mmHg] | Baseline and at Week 42. |
| Absolute change from baseline at Week 42 in diastolic blood pressure (DBP) [mmHg] | Baseline and at Week 42. |
| CMR of Greater New Haven, LLC | Not yet recruiting | Hamden | Connecticut | 06517 | United States |
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| Optimus U Corporation-Miami-69452 | Not yet recruiting | Miami | Florida | 33135 | United States |
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| Javara-Fayetteville-67354 | Not yet recruiting | Fayetteville | Georgia | 30214 | United States |
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| Monroe Biomedical Research - Louisville | Not yet recruiting | Louisville | Kentucky | 40213 | United States |
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| Beth Israel Deaconess Medical Center | Not yet recruiting | Boston | Massachusetts | 02215 | United States |
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| Arcturus Healthcare - Troy Internal Medicine Research Division | Not yet recruiting | Troy | Michigan | 48098 | United States |
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| StudyMetrix Research, LLC | Not yet recruiting | City of Saint Peters | Missouri | 63303 | United States |
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| Clinvest Research LLC | Not yet recruiting | Springfield | Missouri | 65807 | United States |
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| Centricity Research - Morehead City | Not yet recruiting | Morehead City | North Carolina | 28557 | United States |
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| Accellacare-Wilmington-67123 | Not yet recruiting | Wilmington | North Carolina | 28401 | United States |
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| Lillestol Research, LLC | Recruiting | Fargo | North Dakota | 58104 | United States |
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| Tribe Clinical Research at Parkside OB-GYN, Greer | Not yet recruiting | Greer | South Carolina | 29650 | United States |
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| Texas Diabetes and Endocrinology | Not yet recruiting | Austin | Texas | 78731 | United States |
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| South Texas Research Institute - Brownsville | Not yet recruiting | Brownsville | Texas | 78520 | United States |
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| South Texas Research Institute-Edinburg-67012 | Not yet recruiting | Edinburg | Texas | 78539 | United States |
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| IMA Clinical Research San Antonio | Not yet recruiting | San Antonio | Texas | 78229 | United States |
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| Rainier Clinical Research Center | Not yet recruiting | Renton | Washington | 98057 | United States |
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| Allegiance Research Specialists | Not yet recruiting | Wauwatosa | Wisconsin | 53226 | United States |
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| Royal Prince Alfred Hospital | Not yet recruiting | Camperdown | New South Wales | 2050 | Australia |
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| Logan Hospital | Not yet recruiting | Meadowbrook | Queensland | 4131 | Australia |
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| Repatriation General Hospital | Not yet recruiting | Daw Park | South Australia | 5041 | Australia |
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| Monash University | Not yet recruiting | Box Hill | Victoria | 3128 | Australia |
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| Austin Health | Not yet recruiting | Heidelberg | Victoria | 3048 | Australia |
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| Coastal Digestive Health & CDH Research Institute | Not yet recruiting | Queensland | 4558 | Australia |
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| Ocean West Research Clinic (Surrey) | Not yet recruiting | Surrey | British Columbia | V3Z 2N6 | Canada |
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| Hilltop Medical Clinic | Not yet recruiting | Surrey | British Columbia | V4A 0C1 | Canada |
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| Dr. M. B. Jones Inc. | Not yet recruiting | Victoria | British Columbia | V8V 4A1 | Canada |
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| Apex Trials (Guelph) | Not yet recruiting | Guelph | Ontario | N1G 0B4 | Canada |
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| Winterberry Research Inc. | Not yet recruiting | Hamilton | Ontario | L8J 0B6 | Canada |
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| The Wharton Medical Clinic Clinical Trials Inc. | Not yet recruiting | Hamilton | Ontario | L8L 5G8 | Canada |
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| Milestone Research Inc. | Not yet recruiting | London | Ontario | N5W 6A2 | Canada |
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| Stouffville Medical Research Institute Inc. | Not yet recruiting | Stouffville | Ontario | L4A 1H2 | Canada |
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| Canadian Phase Onward Inc. | Not yet recruiting | Toronto | Ontario | M3J 0K2 | Canada |
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| Ecogene-21 | Not yet recruiting | Chicoutimi | Quebec | G7H 7K9 | Canada |
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| THEO Medical (Montreal) | Not yet recruiting | Montreal | Quebec | H3M 1L3 | Canada |
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| Centre Medical Acadie (9109-0126 Quebec Inc) | Not yet recruiting | Montreal | Quebec | H4N 2W2 | Canada |
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| Diex Recherche (Sherbrooke Est) | Not yet recruiting | Sherbrooke | Quebec | J1E 0N8 | Canada |
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| Diex Recherche (Victoriaville) | Not yet recruiting | Victoriaville | Quebec | G6P 3Z8 | Canada |
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| Diex Recherche (Quebec) | Not yet recruiting | Québec | G1V 4T3 | Canada |
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| Huzhou Central Hospital | Not yet recruiting | Huzhou | 313000 | China |
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| Center Hospital of Jinan | Not yet recruiting | Jinan | 250013 | China |
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| The First Affiliated Hospital of Henan University of Science and Technology | Not yet recruiting | Luoyang | 471000 | China |
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| The Second Affiliated Hospital of Nanjing Medical University | Not yet recruiting | Nanjing | 210011 | China |
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| The First Affiliated Hospital of Ningbo University | Not yet recruiting | Ningbo | 315010 | China |
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| First Hospital of Qinhuangdao | Not yet recruiting | Qinhuangdao | 066099 | China |
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| Tianjin Medical University Chu Hisen-I Memorial Hospital | Not yet recruiting | Tianjin | 300070 | China |
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| Yichang Central People's Hospital | Not yet recruiting | Yichang | 443008 | China |
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| Momentum Clinical Research Dunedin | Not yet recruiting | Dunedin | Otago | 9016 | New Zealand |
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| Waitemata Clinical Research | Not yet recruiting | Auckland | 0626 | New Zealand |
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| Auckland City Hospital | Not yet recruiting | Grafton / Auckland | 1023 | New Zealand |
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| Clinical Trials New Zealand Ltd | Not yet recruiting | Hamilton | 3204 | New Zealand |
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| Momentum Clinical Research | Not yet recruiting | Waikanae | 5036 | New Zealand |
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| The Catholic University of Korea, Bucheon St.Mary's Hospital | Not yet recruiting | Bucheon-si | 14647 | South Korea |
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| Eulji University Hospital | Not yet recruiting | Daejeon | 35233 | South Korea |
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| Chosun university hospital | Not yet recruiting | Gwangju | 61453 | South Korea |
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| Seoul National University Bundang Hospital | Not yet recruiting | Seongnam | 13620 | South Korea |
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| Korea University Anam Hospital | Not yet recruiting | Seoul | 02841 | South Korea |
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| Asan Medical Center | Not yet recruiting | Seoul | 05505 | South Korea |
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| Velocity Clinical Research, High Wycombe | Not yet recruiting | High Wycombe | HP11 2QW | United Kingdom |
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| Leicester General Hospital | Not yet recruiting | Leicester | LE5 4PW | United Kingdom |
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| Linthorpe Surgery | Not yet recruiting | Middlesbrough | TS5 6HA | United Kingdom |
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| Banbury Cross Health Centre | Not yet recruiting | Oxford | OX16 9AD | United Kingdom |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| 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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