Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1327-1477 | Other Identifier | World Health Organization (WHO) | |
| 2025-523804-62 | Other Identifier | European Medical Agency (EMA) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this clinical study is to find out if NNC0487-0111 is safe and effective for treating people who have excess body weight. There are 2 study treatments in this study taken as injections under the skin once a week. Participants will either get NNC0487-0111 (the treatment being tested) or Placebo (a treatment that has no active medicine in it). Which treatment participants get is decided by chance.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NNC0487-0111 | Experimental | Participants will receive subcutaneous injection of NNC0487-0111 once weekly as an adjunct to a reduced-calorie diet and increased physical activity. |
|
| Placebo | Placebo Comparator | Participants will receive subcutaneous injection of placebo matched to NNC0487-0111 once weekly as an adjunct to a reduced-calorie diet and increased physical activity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC0487-0111 | Drug | NNC0487-0111 will be administered subcutaneously. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Relative change in body weight | Measured as percentage (%) of body weight. | From week 40 to week 92 |
| Measure | Description | Time Frame |
|---|---|---|
| Relative change in body weight | Measured as % of body weight. | From week 0 to week 92 |
| Change in waist circumference | Measured as centimetre (cm). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Novo Nordisk | Contact | (+1) 866-867-7178 | clinicaltrials@novonordisk.com |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (dept. 2834) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pinnacle Research Group LLC | Recruiting | Anniston | Alabama | 36207 | United States | |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Sponsor staff involved in the clinical trial is masked according to company standard procedures.
| Placebo (matched to NNC0487-0111) |
| Drug |
Placebo will be administered subcutaneously. |
|
| From week 40 to week 92 |
| Change in systolic blood pressure (SBP) | Measured as millimeter of mercury (mmHg). | From week 40 to week 92 |
| Change in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) physical function score | Measured as score on a scale. 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. The physical function score ranges from 0-100. | From week 40 to week 92 |
| Change in SF-36v2® Health Survey Acute (SF-36v2 Acute) physical functioning score | Measured as score on a scale. SF-36v2 Acute measures Health-Related Quality of Life (HRQOL). The measure consists of 36 items yielding 8 health domain scores and 2 component summary scores. SF-36v2 Acute scores are norm-based scores, i.e. transformed to a scale where the 2009 US general population has a mean of 50 and a standard deviation (SD) of 10. Higher scores indicate better functional health and well-being. The physical functioning ranges from 19.0 to 57.6. | From week 40 to week 92 |
| Change in body weight | Measured as kilogram (kg). | From week 40 to week 92 |
| Change in body mass index (BMI) | Measured as kilograms per square meter (kg/m^2). | From week 40 to week 92 |
| Change in body weight | Measured as kg. | From week 0 to week 92 |
| Change in BMI | Measured as kg/m^2. | From week 0 to week 92 |
| Change in glycated haemoglobin (HbA1c) | Measured as % of HbA1c. | From week 40 to week 92 |
| Change in fasting plasma glucose (FPG) | Measured as millimoles per liter (mmol/L). | From week 40 to week 92 |
| Change in fasting insulin | Measured as ratio to baseline. | From week 40 to week 92 |
| Change in diastolic blood pressure (DBP) | Measured as mmHg. | From week 40 to week 92 |
| Change in total cholesterol | Measured as ratio to baseline. | From week 40 to week 92 |
| Change in High-density lipoprotein (HDL) cholesterol | Measured as ratio to baseline. | From week 40 to week 92 |
| Change in Low-density lipoprotein (LDL) cholesterol | Measured as ratio to baseline. | From week 40 to week 92 |
| Change in Very low-density lipoprotein (VLDL) cholesterol | Measured as ratio to baseline. | From week 40 to week 92 |
| Change in non-HDL cholesterol | Measured as ratio to baseline. | From week 40 to week 92 |
| Change in triglycerides | Measured as ratio to baseline. | From week 40 to week 92 |
| Change in high-sensitivity C-reactive protein (hsCRP) | Measured as ratio to baseline. | From week 40 to week 92 |
| Change in HbA1c | Measured as % of HbA1c. | From week 0 to week 92 |
| Change in FPG | Measured as mmol/L. | From week 0 to week 92 |
| Change in fasting insulin | Measured as ratio to baseline. | From week 0 to week 92 |
| Change in DBP | Measured as mmHg. | From week 0 to week 92 |
| Change in total cholesterol | Measured as ratio to baseline. | From week 0 to week 92 |
| Change in HDL cholesterol | Measured as ratio to baseline. | From week 0 to week 92 |
| Change in LDL cholesterol | Measured as ratio to baseline. | From week 0 to week 92 |
| Change in VLDL cholesterol | Measured as ratio to baseline. | From week 0 to week 92 |
| Change in non-HDL cholesterol | Measured as ratio to baseline. | From week 0 to week 92 |
| Change in triglycerides | Measured as ratio to baseline. | From week 0 to week 92 |
| Change in hsCRP | Measured as % of hsCRP. | From week 0 to week 92 |
| Change in waist circumference | Measured as cm. | From week 0 to week 92 |
| Change in SBP | Measured as mmHg. | From week 0 to week 92 |
| Change in IWQOL-Lite-CT: physical composite score | Measured as score on a scale. 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. The physical composite score ranges from 0-100. | From week 40 to week 92 |
| Change in IWQOL-Lite-CT: psychosocial composite score | Measured as score on a scale. 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. The psychosocial composite score ranges from 0-100. | From week 40 to week 92 |
| Change in IWQOL-Lite-CT: total score | Measured as score on a scale. 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. The total score ranges from 0-100. | From week 40 to week 92 |
| Number of Treatment Emergent Adverse Events (TEAEs) | Measured as events. | From week 0 to week 40 |
| Number of Treatment Emergent Serious Adverse Events (TESAEs) | Measured as events. | From week 0 to week 40 |
| Number of TEAEs leading to permanent treatment discontinuation | Measured as events. | From week 0 to week 40 |
| Number of TEAEs | Measured as events. | From week 40 to week 96 |
| Number of TESAEs | Measured as events. | From week 40 to week 96 |
| Number of TEAEs leading to permanent treatment discontinuation | Measured as events. | From week 40 to week 96 |
| Diablo Clinical Research, Inc. |
| Recruiting |
| Walnut Creek |
| California |
| 94598 |
| United States |
| Florida Inst For Clin Res LLC | Recruiting | Orlando | Florida | 32825 | United States |
| Endeavor Health | Recruiting | Skokie | Illinois | 60077 | United States |
| Midwest Inst For Clin Res | Recruiting | Indianapolis | Indiana | 46260 | United States |
| Medication Mgmnt, LLC_Grnsboro | Recruiting | Greensboro | North Carolina | 27405 | United States |
| PMG Research of Wilmington LLC | Recruiting | Wilmington | North Carolina | 28401 | United States |
| UPA Ctr Weight and Eating Dis | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
| Clinical Res Collaborative | Recruiting | Cumberland | Rhode Island | 02864 | United States |
| North Texas Endocrine Center | Not yet recruiting | Dallas | Texas | 75231 | United States |
| UT Southwestern Med Cntr | Recruiting | Dallas | Texas | 75390-9302 | United States |
| Selma Medical Associates | Recruiting | Winchester | Virginia | 22601-3834 | United States |
| Rainier Clin Res Ctr Inc | Recruiting | Renton | Washington | 98057 | United States |
| Conexa | Recruiting | Ciudad Autonoma de Buenos Aires | Buenos Aires | C1018ADE | Argentina |
| CICEMO- Consultorio (Av Directorio) | Recruiting | Ciudad Autónoma de Buenos Aires | Buenos Aires | C1424CIQ | Argentina |
| Instituto de Investigaciones Clinicas Mar Del Plata | Recruiting | Mar del Plata | Buenos Aires | B7600FZN | Argentina |
| CIPREC Pueyrredon | Recruiting | Buenos Aires | C1119ACN | Argentina |
| Sydney Clinical Trials | Recruiting | Campbelltown | New South Wales | 2560 | Australia |
| Sydney Cardiometabolic Centre | Recruiting | Liverpool | New South Wales | 2170 | Australia |
| Hunter Diabetes Centre | Recruiting | Merewether | New South Wales | 2291 | Australia |
| Nightingale Research | Recruiting | Adelaide | South Australia | 5000 | Australia |
| Anima Research Center | Recruiting | Diepenbeek | 3590 | Belgium |
| AZ Groeninge - Kortrijk - Centrum Endo - Diabetologie | Recruiting | Kortrijk | 8500 | Belgium |
| Centre hospitalier universitaire de Liège (CHU de Liège) | Recruiting | Liège | 4000 | Belgium |
| AZ OOSTENDE (Campus DAMIAAN) | Not yet recruiting | Ostend | 8400 | Belgium |
| DCC 1 - Lom EOOD | Recruiting | Lom | 3600 | Bulgaria |
| MHAT Med Line Clinic | Recruiting | Plovdiv | 4000 | Bulgaria |
| UMHAT Kaspela EOOD, Endocrinology and Metabolic Diseases Clinic | Recruiting | Plovdiv | 4001 | Bulgaria |
| AIPSOMCEMD ENDO MED CONSULT 2020 - Dr. Aleksander Botushanov EOOD | Recruiting | Plovdiv | 4002 | Bulgaria |
| SGHAT Dr. Shterev EOOD | Recruiting | Sofia | 1330 | Bulgaria |
| UMHAT Aleksandrovska EAD, Clinic of Endocrinology and Metabolic Diseases | Recruiting | Sofia | 1431 | Bulgaria |
| Medical Center Maraya Med EOOD | Recruiting | Sofia | 1756 | Bulgaria |
| AIPSMC Dr. Traykovska EOOD | Recruiting | Sofia | 1839 | Bulgaria |
| Sjællands Universitetshospital, Køge - Medicinsk Afdeling | Recruiting | Køge | Region Sjælland | 4600 | Denmark |
| Sydvestjysk Sygehus Esbjerg - Medicinsk Endokrinologisk Ambulatorium, Forskningsenheden | Recruiting | Esbjerg | Region Syddanmark | 6700 | Denmark |
| Sanos Clinic - Vejle | Recruiting | Vejle | Region Syddanmark | 7100 | Denmark |
| CHU DE CLERMONT-FERRAND-HOPITAL GABRIEL MONTPIED_Service de Nutrition | Recruiting | Clermont-Ferrand | 63000 | France |
| CHU GRENOBLE ALPES-SITE NORD MICHALLON_Endocrinologie,diabétologie,maladies de la nutrition | Recruiting | La Tronche | 38700 | France |
| GROUPE SOS SANTE-HOPITAL LE CREUSOT-HOTEL DIEU_ Service de Diabétologie | Recruiting | Le Creusot | 71200 | France |
| CHU LILLE-HOPITAL CLAUDE HURIEZ_Service de Chirurgie Générale et Endocrinienne | Recruiting | Lille | 59000 | France |
| CHU DE POITIERS_Centre d'investigation Clinique | Recruiting | Poitiers | 86000 | France |
| Diabetologikum - Diabetologische Schwerpunktpraxis Dr. Thomas Segiet | Recruiting | Speyer | LÄK Rheinland-Pfalz | 67346 | Germany |
| Wendisch - Dahl Hamburg - DZHW | Recruiting | Hamburg | 22607 | Germany |
| Prof. Dr. Schiefke Ingolf, EUGASTRO GmbH | Recruiting | Leipzig | 04103 | Germany |
| Diabetologische Gemeinschaftspraxis Dr. Staudenmeyer und Dr. Schiwietz | Recruiting | Lingen | 49808 | Germany |
| Institut für Diabetesforschung GmbH Münster - Dr. med. Rose | Recruiting | Münster | 48145 | Germany |
| RED-Institut für medizinische Forschung und Fortbildung GmbH | Recruiting | Oldenburg in Holstein | 23758 | Germany |
| Zentrum für klinische Studien Alexander Segner | Recruiting | Saint Ingbert-Oberwürzbach | 66386 | Germany |
| Arcispedale Sant'Anna (Cona) - UO di Endocrinologia | Not yet recruiting | Ferrara | Emilia-Romagna | 44124 | Italy |
| IRCCS Ospedale Policlinico San Martino - Medicina Interna e Specialità Mediche | Recruiting | Genoa | Liguria | 16132 | Italy |
| Fondazione Salvatore Maugeri I.R.C.C.S. - Pavia - Dipartimento Medicina Interna e Generale | Recruiting | Pavia | Lombardy | 27100 | Italy |
| Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone - Presidio Villa Belmonte | Recruiting | Palermo | Sicily | 90127 | Italy |
| Azienda Ospedaliera di Padova - UOSD Chirurgia Bariatrica | Not yet recruiting | Padova | Veneto | 35128 | Italy |
| Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Civile Maggiore Borgo Trento - U.O. Geriatria | Recruiting | Verona | Veneto | 37126 | Italy |
| A.O.Universitaria S.ORSOLA-MALPIGHI - U.O.Endocrinologia e Cura | Recruiting | Bologna | 40138 | Italy |
| IRCCS Humanitas - U.O. Endocrinologia e Diabetologia | Recruiting | Rozzano (MI) | 20089 | Italy |
| PreCare Trial & Recruitment | Recruiting | Born | Limburg | 6121 XK | Netherlands |
| Progress Clinical Research Den Bosch | Recruiting | 's-Hertogenbosch | North Brabant | 5223 LA | Netherlands |
| EB Flevo Research BV | Recruiting | Almere Stad | 1311RL | Netherlands |
| Meander MC | Not yet recruiting | Amersfoort | 3813 TZ | Netherlands |
| Rijnstate Ziekenhuis | Recruiting | Arnhem | 6815 AD | Netherlands |
| Centro Periferico De Especialidades Bola Azul | Recruiting | Almería | 04009 | Spain |
| Hospital Clinic i Provincial | Recruiting | Barcelona | 08036 | Spain |
| H. de León_Endocrinología | Recruiting | León | 24008 | Spain |
| Hospital Clínico San Carlos | Recruiting | Madrid | 28040 | Spain |
| H. Clinico Univ. Virgen de la Victoria | Recruiting | Málaga | 29010 | Spain |
| H.U. Quirónsalud Madrid | Recruiting | Pozuelo de Alarcón | 28223 | Spain |
| Hospital Universitario Virgen del Rocío | Recruiting | Seville | 41013 | Spain |
| EMS Healthcare | Recruiting | Cheshire | CH65 4LE | United Kingdom |
| Clifton Medical Centre | Recruiting | Rotherham | S65 1DA | United Kingdom |
| Staploe Medical Centre | Recruiting | Soham | CB7 5JD | United Kingdom |
| Albany House Medical Centre | Recruiting | Wellingborough | NN8 4RW | United Kingdom |
| 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 |
Not provided
Not provided