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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1291-5907 | Other Identifier | World Health Organization (WHO) | |
| 2023-505857-42 | EudraCT Number |
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This study will look if CagriSema can lower kidney damage in people with chronic kidney disease (CKD), type 2 diabetes (T2D) and overweight or obesity. CagriSema is a new investigational medicine. CagriSema cannot yet be prescribed by doctors. The study will compare CagriSema to the 2 medicines semaglutide and cagrilintide, when they are taken alone. It will also compare CagriSema to a "dummy" medicine (also called placebo) without any active ingredient. Participant will either get CagriSema, semaglutide, cagrilintide or placebo. Which treatment participant will get is decided by chance (like flipping a coin). Study doctor will not know which of the study medicines participant will get. For each participant, the study will last for about 35 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CagriSema | Experimental | Participants will receive cagrilintide and semaglutide subcutaneously once-weekly after a dose escalation period of 16 weeks during the maintenance period for 10 weeks. |
|
| Semaglutide | Experimental | Participants will receive semaglutide and placebo matched to cagrilintide subcutaneously once-weekly after a dose escalation period of 16 weeks during the maintenance period for 10 weeks. |
|
| Cagrilintide | Experimental | Participants will receive cagrilintide and placebo matching to semaglutide subcutaneously once-weekly after a dose escalation period of 16 weeks during the maintenance period for 10 weeks. |
|
| Placebo | Placebo Comparator | Participants will receive placebo matched to cagrilintide and placebo matched to semaglutide subcutaneously once weekly for 26 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cagrilintide | Drug | Participants will receive Cagrilintide subcutaneously. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in urinary albumin-to-creatinine ratio (UACR) | Measured in ratio to baseline. | From baseline (week 0) to end of treatment (week 26) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in estimated glomerular filtration rate (eGFR) (creatinine and cystatin C-based chronic kidney disease (CKD)-Epidemiology Collaboration equation (EPI) 2021) | Measured in milliliters per minute per 1.73 meters square (mL/min/1.73 m^2). | From baseline (week 0) to end of treatment (week 26) |
| Change in eGFR (creatinine-based CKD-EPI 2021) |
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Inclusion Criteria:
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 |
|---|---|---|---|---|---|---|
| John Muir Physicians Network | Concord | California | 94520 | United States | ||
| Valley Research |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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| Semaglutide | Drug | Participants will receive semaglutide subcutaneously. |
|
| Placebo | Drug | Participants will receive placebo matched to cagrilintide or placebo matched to semaglutide subcutaneously. |
|
Measured in mL/min/1.73 m^2. |
| From baseline (week 0) to end of treatment (week 26) |
| Relative change in body weight | Measured in percentage (%). | From baseline (week 0) to end of treatment (week 26) |
| Achievement of greater than or equal to (≥) 5 % weight reduction | Count of participants. | From baseline (week 0) to end of treatment (week 26) |
| Achievement of ≥ 10 % weight reduction | Count of participants. | From baseline (week 0) to end of treatment (week 26) |
| Change in waist circumference | Measured in centimeter (cm). | From baseline (week 0) to end of treatment (week 26) |
| Change in glycated haemoglobin (HbA1c) | Measured in %-points. | From baseline (week 0) to end of treatment (week 26) |
| Change in systolic blood pressure | Measured in millimeters of mercury (mmHg). | From baseline (week 0) to end of treatment (week 26) |
| Change in diastolic blood pressure | Measured in mmHg. | From baseline (week 0) to end of treatment (week 26) |
| Number of treatment emergent adverse events (TEAEs) | count of events. | From baseline (week 0) to end of study (week 32) |
| Number of treatment emergent serious adverse events (SAEs) | count of events. | From baseline (week 0) to end of study (week 32) |
| Number of clinically significant hypoglycaemic episodes (level 2) ( blood glucose less than [<] 3.0 millimoles per liter [mmol/L] (54 milligram per deciliter [mg/dL])) | Count of episodes. | From baseline (week 0) to end of study (week 32) |
| Number of severe hypoglycaemic episodes (level 3): hypoglycaemia associated with severe cognitive impairment requiring external assistance for recovery, with no specific glucose threshold | Count of episodes. | From baseline (week 0) to end of study (week 32) |
| Fresno |
| California |
| 93720 |
| United States |
| Desert Oasis Hlthcr Med Group | Palm Springs | California | 91355 | United States |
| North America Research Institute | San Dimas | California | 91773 | United States |
| NorCal Endocrinology and Internal Medicine | San Ramon | California | 94583 | United States |
| Northeast Research Institute | Fleming Island | Florida | 32003 | United States |
| Life Spring Research Foundation LLC | Miami | Florida | 33130 | United States |
| Advent Health Translational Research Institute | Orlando | Florida | 32804 | United States |
| Velocity Clin. Res Valparaiso | Valparaiso | Indiana | 46383 | United States |
| Elite Research Center | Flint | Michigan | 48532 | United States |
| Univ. of Nebraska Medical Center_Omaha | Omaha | Nebraska | 68198 | United States |
| Albany Medical College | Albany | New York | 12203 | United States |
| NYU Langone Nephrology Associates | Mineola | New York | 11501 | United States |
| New York University Grossman School of Medicine | New York | New York | 10016 | United States |
| Southgate Medical Group, LLP | West Seneca | New York | 14224 | United States |
| Carteret Medical Group | Morehead City | North Carolina | 28557 | United States |
| Eastern Nephrology Associates, PLLC | New Bern | North Carolina | 28562 | United States |
| Brookview Hills Research Associates, LLC | Winston-Salem | North Carolina | 27103 | United States |
| Ohio- Advanced Medical Research | Maumee | Ohio | 43537 | United States |
| Heritage Valley Multispeciality Group Inc | Beaver | Pennsylvania | 15009 | United States |
| Main Street Physician's Care | Little River | South Carolina | 29566 | United States |
| Osvaldo A. Brusco MD | Corpus Christi | Texas | 78414 | United States |
| Southwest Houston Research Ltd | Houston | Texas | 77099 | United States |
| Clinical Advancement Center | San Antonio | Texas | 78212 | United States |
| Clinical Investigation Specialists Inc, Kenosha | Kenosha | Wisconsin | 53144 | United States |
| Mautalen Salud e investigación | CABA | Buenos Aires | C1128 AAF | Argentina |
| Centro de Investigaciones Médicas Mar del Plata | Mar del Plata | Buenos Aires | B7600GNY | Argentina |
| Fundación CESIM | Santa Rosa | La Pampa Province | 6300 | Argentina |
| Centro Medico Dra. Laura Maffei e Investigacion Clínica Apli | Buenos Aires | C1425AGC | Argentina |
| Centro Médico Privado San Vicente Diabetes | Córdoba | X5006IKK | Argentina |
| Instituto Pró-Renal Brasil | Curitiba | Paraná | 80440-020 | Brazil |
| Núcleo de Pesquisa Clínica do Rio Grande do Sul Ltda. | Porto Alegre | Rio Grande do Sul | 90430-001 | Brazil |
| CPCLIN - Centro de Pesquisas Clínicas | São Paulo | São Paulo | 01228-200 | Brazil |
| Hospital do Rim e Hipertensao Fundacao Oswaldo Ramos | São Paulo | 04038-002 | Brazil |
| Centricity Research Calgary Endocrinology | Calgary | Alberta | T2H 2G4 | Canada |
| Centricity Research Brampton Endocrinology | Brampton | Ontario | L6S 0C6 | Canada |
| Centricity Research Vaughn Endocrinology | Concord | Ontario | L4K 4M2 | Canada |
| Centricity Research Etobicoke Endocrinology | Etobicoke | Ontario | M9R 4E1 | Canada |
| Hamilton Medical Rsrch Grp | Hamilton | Ontario | L8L 5G4 | Canada |
| Bluewater Clin Res Group Inc | Sarnia | Ontario | N7T 4X3 | Canada |
| UHN-Toronto General Hospital | Toronto | Ontario | M5G 2N2 | Canada |
| Ctr de recherche Clinique de Laval | Laval | Quebec | H7T 2P5 | Canada |
| Centre Medical Acadie | Montreal | Quebec | H4N 2W2 | Canada |
| Groupe Sos Sante-Hopital Le Creusot-Hotel Dieu | Le Creusot | 71200 | France |
| Hôpitaux Saint-Joseph & Marie-Lannelongue | Paris | 75674 | France |
| Centre Hospitalier Universitaire de Poitiers | Poitiers | 86000 | France |
| Chu de Reims-Hopital Maison Blanche | Reims | 51092 | France |
| Centre Hospitalier Universitaire de Nantes-Hopital Nord Laennec | Saint-Herblain | 44800 | France |
| Centre Hospitalier Universitaire de Toulouse-Hopital Rangueil | Toulouse | 31059 | France |
| Centre de Recherche Clinique Portes Du Sud | Vénissieux | 69200 | France |
| University General Hospital Of Heraklion | Heraklion | Crete | 71500 | Greece |
| "Laiko" General Hospital of Athens | Athens | 11527 | Greece |
| Gen Hospital of Athens Laiko,1st Dpt. of Propaedeutic Inter | Athens | 11527 | Greece |
| General hospital of Athens 'G.Gennimatas' | Athens | 11527 | Greece |
| Iatriko Athinon 'Palaiou Falirou' | Athens | 17562 | Greece |
| "Laiko" General Hospital of Athens | Athens | GR-11527 | Greece |
| Gen Hospital of Athens Laiko,1st Dpt. of Propaedeutic Inter | Athens | GR-11527 | Greece |
| General hospital of Athens 'G.Gennimatas' | Athens | GR-11527 | Greece |
| General Hospital of Lamia | Lamia | 35100 | Greece |
| Univ Gen Hospital Larisa | Larissa | 41110 | Greece |
| Univ Gen Hospital Larisa, Endocrinology & Metabolic Disease | Larissa | GR-41110 | Greece |
| General University Hospital of Patras,Nephrology clinic | Pátrai | GR-26504 | Greece |
| General University Hospital of Patras,Nephrology clinic | Rio, Patra | 26504 | Greece |
| General Hospital of Thessaloniki 'G. Gennimatas | Thessaloniki | 54635 | Greece |
| "Ippokrateio" G.H. of Thessaloniki | Thessaloniki | 54642 | Greece |
| General Hospital of Thessaloniki "Ippokrateio" | Thessaloniki | 54642 | Greece |
| General Hospital of Thessaloniki "G.Papanikolaou" | Thessaloniki | 57010 | Greece |
| General Hospital of Thessaloniki 'G. Gennimatas | Thessaloniki | GR-54635 | Greece |
| "Ippokrateio" G.H. of Thessaloniki | Thessaloniki | GR-54642 | Greece |
| General Hospital of Thessaloniki "G.Papanikolaou" | Thessaloniki | GR-57010 | Greece |
| PTE-AOK II. Belgyogyaszati Klinika es Nephrologiai Centrum | Pécs | Baranya Vármegye | 7623 | Hungary |
| Lausmed Kft. | Baja | Bács-Kiskun county | 6500 | Hungary |
| Belinus Bt. | Debrecen | Hajdú-Bihar | 4025 | Hungary |
| Siófoki Kórház, Diabetológiai Szakrendelés | Siófok | Somogy County | 8600 | Hungary |
| Borbánya Praxis E.Ü. Kft. | Nyíregyháza | Szabolcs-Szatmar Varmegye | 4405 | Hungary |
| Szent Margit Rendelőintézet Nonprofit Kft. | Budapest | 1032 | Hungary |
| Békés Megyei Központi Kórház | Gyula | 5700 | Hungary |
| Endolife Specialty Hospitals | Guntur | Andhra Pradesh | 522001 | India |
| NIZAM'S Institute of Medical Sciences | Hyderabad | Andhra Pradesh | 500082 | India |
| Sunrise Hospital | Vijayawada | Andhra Pradesh | 520002 | India |
| Lifecare Hospital and Research Centre | Bengaluru | Karnataka | 560066 | India |
| Seth GS Medical College & KEM Hospital | Mumbai | Maharashtra | 400012 | India |
| King Edward Memorial Hospital | Pune- Maharashtra | Maharashtra | 411011 | India |
| Maulana Azad Medical College | Delhi | New Delhi | 110002 | India |
| Madras Diabetes Research Foundation | Chennai | Tamil Nadu | 600086 | India |
| Shri Mahant Indiresh Hospital | Dehradun | Uttarakhand | 248001 | India |
| Seino Internal Medicine Clinic_Internal medicine | Koriyama-shi, Fukushima | Fukushima, Japan | 963-8851 | Japan |
| Nippon Kokan Fukuyama Hospital_Diabetology | Fukuyama-shi, Hiroshima | 721-0927 | Japan |
| Sasaki Internal Medicine | Hokkaido | 062-0007 | Japan |
| Nishiyamado Keiwa Hospital_Internal Medicine | Ibaraki | 331-0133 | Japan |
| Kanno Naika_Internal Medicine | Mitaka-shi, Tokyo | 181-0013 | Japan |
| Minami Akatsuka Clinic | Mito-shi, Ibaraki | 311-4153 | Japan |
| Tokyo-Eki Center-building Clinic_Internal Medicine | Tokyo | 103-0027 | Japan |
| Fukuwa Clinic_Internal Medicine | Tokyo | 104-0031 | Japan |
| Fukuwa Clinic | Tokyo | 104-0031 | Japan |
| Osteo Medic s.c. Artur Racewicz Jerzy Supronik | Bialystok | Podlaskie Voivodeship | 15-351 | Poland |
| NZOZ Specjalistyczny Osrodek Internistyczno-Diabetologiczny Małgorzata Arciszewska | Bialystok | Podlaskie Voivodeship | 15-435 | Poland |
| Kresmed Sp. z o. o. | Bialystok | Podlaskie Voivodeship | 15-481 | Poland |
| M2M Med. Badania Sp. z o.o. | Chorzów | Silesian Voivodeship | 41-500 | Poland |
| M2M Med. Sp. z o.o. Sp. j. | Chorzów | 41-500 | Poland |
| Pratia S.A. | Gdynia | 81-338 | Poland |
| Pratia S.A. | Katowice | 40-081 | Poland |
| Gabinet Lekarski Malgorzata Saryusz-Wolska | Lodz | 90-132 | Poland |
| Etyka Osrodek Badan Klinicznych Tomasz Pesta S.K.A. | Olsztyn | 10-117 | Poland |
| Gaja Poradnie Lekarskie | Poznan | 61-251 | Poland |
| Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji | Warsaw | 02-507 | Poland |
| Centrum Medyczne Oporow | Wroclaw | 52-416 | Poland |
| Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Szyszko | Zabrze | 41-800 | Poland |
| KARDIO-SANUS, spol. s r.o. | Bratislava | 84108 | Slovakia |
| MEDISPEKTRUM s.r.o. | Bratislava | 851 01 | Slovakia |
| HUMAN-CARE, s.r.o. | Košice | 040 01 | Slovakia |
| Univerzitna nemocnica L. Pasteura Kosice | Košice | 040 01 | Slovakia |
| Vysokospecializovany odborny ustav geriatricky sv. Lukasa v Kosiciach, n.o. | Košice | 040 01 | Slovakia |
| Tatratrial s.r.o. | Rožňava | 048 01 | Slovakia |
| Hospital Universitario Puerta de Hierro Majadahonda | Majadahonda | Madrid | 28222 | Spain |
| Hospital Fundación Alcorcón | Alcorcón | 28922 | Spain |
| Hospital Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital de Bellvitge | L'Hospitalet de Llobregat | 08907 | Spain |
| Hospital Gregorio Marañón | Madrid | 28007 | Spain |
| Hospital Universitario de Canarias | Santa Cruz de Tenerife | 38320 | Spain |
| Hospital Clinico Universitario de Valencia | Valencia | 46010 | Spain |
| Siriraj Hospital | Bangkok Noi | Bangkok | 10700 | Thailand |
| Thammasat University Hospital | Klong Luang | Changwat Pathum Thani | 12120 | Thailand |
| Maharaj Nakorn Chiang Mai Hospital_Nephrology | Chiang Mai | Mueang Chiang Mai | 50200 | Thailand |
| King Chulalongkorn Memorial Hospital | Bangkok | 10330 | Thailand |
| Phramongkutklao Hospital | Bangkok | 10400 | Thailand |
| Siriraj Hospital | Bangkok | 10700 | Thailand |
| Thammasat Hospital_CRC | Pathum Thani | 12120 | Thailand |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D003924 | Diabetes Mellitus, Type 2 |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| C000717792 | cagrilintide |
| C000591245 | semaglutide |
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