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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1291-9210 | Other Identifier | World Health Organization (WHO) | |
| jRCT2051230198 | Registry Identifier | JRCT |
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This study will look at how a new medicine called NNC0519-0130 helps people with excess body weight lose weight. The study will test up to 6 different doses of NNC0519-0130. Participants will take 1-2 injections once a week. The study medicine will be injected under skin with a thin needle in the stomach, thigh, or upper arm. The study will last for about 42 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dosing scheme a: NNC0519-0130 | Experimental | Participants will receive NNC0519-0130 at 1 dose level subcutaneously (s.c.) once-weekly up to 36 weeks. |
|
| Dosing scheme a: Placebo | Placebo Comparator | Participants will receive NNC0519-0130 matched placebo s.c. once-weekly up to 36 weeks. |
|
| Dosing scheme b: NNC0519-0130 | Experimental | Participants will receive NNC0519-0130 at 2 dose levels s.c. once-weekly up to 36 weeks. |
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| Dosing scheme b: Placebo | Placebo Comparator | Participants will receive NNC0519-0130 matched placebo s.c. once-weekly up to 36 weeks. |
|
| Dosing scheme c: NNC0519-0130 | Experimental | Participants will receive NNC0519-0130 at 3 dose levels s.c. once-weekly up to 36 weeks. |
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| Dosing scheme c: Placebo |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC0519-0130 | Drug | NNC0519-0130 will be administered subcutaneously. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Relative change in body weight | Measured in percentage of body weight. | From baseline (week 0) to end of treatment (week 36) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in body weight | Measured in kilograms (kg) | From baseline (week 0) to end of treatment (week 36) |
| Achievement of greater than equal to (≥) 5% weight reduction | Count of participants |
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Inclusion Criteria:
Female of non-childbearing potential, or male.
a. For US only: Female of childbearing potential using highly effective non-systemic methods of contraception with low user-dependency at least 2 months prior to screening and willingness to continue using it through-out the study, or male.
Age 18-75 years (both inclusive) at the time of signing the informed consent.
History of at least one self-reported unsuccessful dietary effort to lose body weight.
a) BMI ≥ 27.0 kg/m2 with the presence of at least one weight-related co-morbidity including, but not limited to, hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease.
b) BMI ≥ 30.0 kg/m2.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (dept. 2834) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centricity Research-Arizona | Mesa | Arizona | 85206 | United States | ||
| Arkansas Clinical Research |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Participants will receive NNC0519-0130 matched placebo s.c. once-weekly up to 36 weeks. |
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| Dosing scheme d: NNC0519-0130 | Experimental | Participants will receive NNC0519-0130 at 4 dose levels s.c. once-weekly up to 36 weeks. |
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| Dosing scheme d: Placebo | Placebo Comparator | Participants will receive NNC0519-0130 matched placebo s.c. once-weekly up to 36 weeks. |
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| Dosing scheme e: NNC0519-0130 | Experimental | Participants will receive NNC0519-0130 at 5 dose levels s.c. once-weekly up to 36 weeks. |
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| Dosing scheme e: Placebo | Placebo Comparator | Participants will receive NNC0519-0130 matched placebo s.c. once-weekly up to 36 weeks. |
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| Dosing scheme f: NNC0519-0130 | Experimental | Participants will receive NNC0519-0130 at 6 dose levels s.c. once-weekly up to 36 weeks. |
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| Dosing scheme f: Placebo | Placebo Comparator | Participants will receive NNC0519-0130 matched placebo s.c. once-weekly up to 36 weeks. |
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| Dosing scheme g: Tirzepatide | Active Comparator | Participants will receive tirzepatide at 6 dose levels s.c. once weekly up to 36 weeks. |
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| Placebo | Drug | Placebo will be administered subcutaneously. |
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| Tirzepatide | Drug | Tirzepatide will be administered subcutaneously. |
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| From baseline (week 0) to end of treatment (week 36) |
| Achievement of ≥ 10% weight reduction | Count of participants | From baseline (week 0) to end of treatment (week 36) |
| Achievement of ≥ 15% weight reduction | Count of participants | From baseline (week 0) to end of treatment (week 36) |
| Achievement of ≥ 20% weight reduction | Count of participants | From baseline (week 0) to end of treatment (week 36) |
| Change in body mass index (BMI) | Measured in Kilogram per meter square (Kg/m^2) | From baseline (week 0) to end of treatment (week 36) |
| Change in waist circumference | Measured in centimeter (cm) | From baseline (week 0) to end of treatment (week 36) |
| Change in glycated hemoglobin (HbA1c) | Measured in percentage point (%-point) | From baseline (week 0) to end of treatment (week 36) |
| Change in fasting plasma glucose (FPG) | Measured in millimoles per liter (mmol/L) | From baseline (week 0) to end of treatment (week 36) |
| Change in systolic blood pressure (SBP) | Measured in milliters of mercury (mmHg) | From baseline (week 0) to end of treatment (week 36) |
| Change in high sensitivity C-Reactive protein (hsCRP) | Ratio to baseline | From baseline (week 0) to end of treatment (week 36) |
| Change in total cholesterol | Ratio to baseline | From baseline (week 0) to end of treatment (week 36) |
| Change in high-density lipoprotein (HDL) cholesterol | Ratio to baseline | From baseline (week 0) to end of treatment (week 36) |
| Change in low-density lipoprotein (LDL) cholesterol | Ratio to baseline | From baseline (week 0) to end of treatment (week 36) |
| Change in triglycerides | Ratio to baseline | From baseline (week 0) to end of treatment (week 36) |
| Change in Impact of Weight on Quality of Life-Lite Clinical Trials (IWQOL-Lite-CT) Physical composite score | IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Higher scores indicate better levels of functioning. Total score range is 0-100. Composite score ranges are: physical composite (0-100), psychosocial composite (0-100), and physical function composite (0-100). | From baseline (week 0) to end of treatment (week 36) |
| Change in IWQOL-Lite-CT Psychosocial composite score | IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Higher scores indicate better levels of functioning. Total score range is 0-100. Composite score ranges are: physical composite (0-100), psychosocial composite (0-100), and physical function composite (0-100). | From baseline (week 0) to end of treatment (week 36) |
| Change in IWQOL-Lite-CT Physical Function score | IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Higher scores indicate better levels of functioning. Total score range is 0-100. Composite score ranges are: physical composite (0-100), psychosocial composite (0-100), and physical function composite (0-100). | From baseline (week 0) to end of treatment (week 36) |
| Change in IWQOL-Lite-CT Total score | IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Higher scores indicate better levels of functioning. Total score range is 0-100. Composite score ranges are: physical composite (0-100), psychosocial composite (0-100), and physical function composite (0-100). | From baseline (week 0) to end of treatment (week 36) |
| Number of adverse events | Count of events | From baseline (week 0) to end of treatment (week 40) |
| Little Rock |
| Arkansas |
| 72205 |
| United States |
| Unity Health-Searcy Medical Center | Searcy | Arkansas | 72143 | United States |
| FDRC | Costa Mesa | California | 92627 | United States |
| Encompass Clinical Research_Spring Valley | Spring Valley | California | 91978 | United States |
| UCLA Health Southbay Endocrine | Torrance | California | 90505 | United States |
| Diablo Clinical Research, Inc. | Walnut Creek | California | 94598 | United States |
| Univ of Colorado at Denver | Aurora | Colorado | 80045 | United States |
| Nature Coast Clinical Research | Crystal River | Florida | 34429 | United States |
| Northeast Research Institute | Fleming Island | Florida | 32003 | United States |
| Jacksonville Ctr For Clin Res | Jacksonville | Florida | 32216 | United States |
| South Broward Research LLC | Miramar | Florida | 33027 | United States |
| Cedar-Crosse Research Center | Chicago | Illinois | 60607 | United States |
| Midwest Inst For Clin Res | Indianapolis | Indiana | 46260 | United States |
| Velocity Clin. Res Valparaiso | Valparaiso | Indiana | 46383 | United States |
| L-MARC Research Center | Louisville | Kentucky | 40213 | United States |
| Centennial Medical Group | Columbia | Maryland | 21045 | United States |
| StudyMetrix Research LLC | City of Saint Peters | Missouri | 63303 | United States |
| NYU Bariatric Surgical Ctr | New York | New York | 10016 | United States |
| Rochester Clinical Research, Inc. | Rochester | New York | 14609 | United States |
| Velocity Clinical Res. Inc Vestal | Vestal | New York | 13850 | United States |
| Medication Mgmnt, LLC_Grnsboro | Greensboro | North Carolina | 27405 | United States |
| PharmQuest Life Sciences LLC | Greensboro | North Carolina | 27408 | United States |
| Physicians East Endocrinology | Greenville | North Carolina | 27834 | United States |
| Piedmont Healthcare Statesville | Statesville | North Carolina | 28625 | United States |
| Piedmont Healthcare/Research | Statesville | North Carolina | 28625 | United States |
| Accellacare | Wilmington | North Carolina | 28401 | United States |
| Velocity Clinical Res | Cleveland | Ohio | 44122 | United States |
| Remington Davis Inc | Columbus | Ohio | 43215 | United States |
| Providence Health Partners Ctr | Dayton | Ohio | 45439 | United States |
| Centricity Research - Ohio | Dublin | Ohio | 43016 | United States |
| Family Practice Center of Wadsworth Inc. | Wadsworth | Ohio | 44281-9236 | United States |
| Lynn Institute of Norman | Norman | Oklahoma | 73072 | United States |
| The University of Penn Center | Philadelphia | Pennsylvania | 19104-3317 | United States |
| Preferred Primary Care Physicians_Pittsburgh | Pittsburgh | Pennsylvania | 15243 | United States |
| Velocity Clin Res Providence | East Greenwich | Rhode Island | 02818 | United States |
| Medical University Of South Carolina | Charleston | South Carolina | 29425 | United States |
| Spartanburg Medical Research | Spartanburg | South Carolina | 29303 | United States |
| Holston Medical Group Pc | Bristol | Tennessee | 37620-7352 | United States |
| Baylr Sctt White Rs Inst, Endo | Dallas | Texas | 75226 | United States |
| Velocity Clinical Res-Dallas | Dallas | Texas | 75230 | United States |
| North Texas Endocrine Center | Dallas | Texas | 75231 | United States |
| UT Southwestern Medical Center - Lingvay | Dallas | Texas | 75390 | United States |
| DCOL Ctr for Clin Res | Longview | Texas | 75605 | United States |
| Washington Cntr Weight Mgmt | Arlington | Virginia | 22206 | United States |
| Health Res of Hampton Roads | Newport News | Virginia | 23606 | United States |
| TPMG Clinical Research | Newport News | Virginia | 23606 | United States |
| National Clin Res Inc. | Richmond | Virginia | 23294 | United States |
| Selma Medical Associates | Winchester | Virginia | 22601-3834 | United States |
| Paratus Clinical | Bruce | Australian Capital Territory | 2617 | Australia |
| Paratus Clinical | Blacktown | New South Wales | 2148 | Australia |
| Northern Beaches Clinical Research | Brookvale | New South Wales | 2100 | Australia |
| Momentum Clinical Research Darlinghurst | Darlinghurst | New South Wales | 2010 | Australia |
| Paratus Clinical | Kanwal | New South Wales | 2259 | Australia |
| Novatrials | Kotara | New South Wales | 2289 | Australia |
| Sutherland Shire Clinical Research | Miranda | New South Wales | 2228 | Australia |
| University of Sunshine Coast | Birtinya | Queensland | 4575 | Australia |
| Paratus Clinical | Herston | Queensland | 4006 | Australia |
| University of Sunshine Coast | Morayfield | Queensland | 4506 | Australia |
| University of Sunshine Coast | Sippy Downs | Queensland | 4556 | Australia |
| University of Sunshine Coast | South Brisbane | Queensland | 4101 | Australia |
| Momentum Clinical Research | Taringa | Queensland | 4068 | Australia |
| Momentum Clinical Research | Tarragindi | Queensland | 4121 | Australia |
| CMAX Clinical Research | Norwood | South Australia | 5067 | Australia |
| Emeritus Research Melbourne | Camberwell | Victoria | 3124 | Australia |
| Austin Health, Metabolic Disorders Centre | Heidelberg Heights | Victoria | 3081 | Australia |
| Momentum Clinical Research | St Albans | Victoria | 3021 | Australia |
| Linear Clinical Research | Nedlands | Western Australia | 6009 | Australia |
| OCROM Clinic_Internal medicine | Suita-shi | Osaka | 565-0853 | Japan |
| ToCROM Clinic_Internal Medicine | Tokyo | 160-0008 | 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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| ID | Term |
|---|---|
| D000098860 | Tirzepatide |
| ID | Term |
|---|---|
| D000067757 | Glucagon-Like Peptide-1 Receptor |
| D000067756 | Glucagon-Like Peptide Receptors |
| D043562 | Receptors, G-Protein-Coupled |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011964 | Receptors, Gastrointestinal Hormone |
| D018000 | Receptors, Peptide |
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