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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1317-0133 | Other Identifier | World Health Organization | |
| 2024-520448-41 | Other Identifier | European Medical Agency (EMA) |
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The study is withdrawn due to strategic reasons.
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This study is being done to find out how well a medicine called CagriSema helps people with overweight or obesity lose weight. CagriSema is still being tested in studies and is not yet available for doctors to prescribe. In this study the sponsor will compare two version of CagriSema injected by two different types of injection devices. Which treatment participants get is decided by chance using a computer program, so neither participants nor study staff will know which treatment is given. The study will last for about one year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CagriSema B in device 2 + Placebo in device 1 | Experimental | Participants will receive CagriSema B in device 2 followed by placebo matched to CagriSema in device 1 subcutaneously once weekly in a dose escalation manner for 16 weeks until the target maintenance dose and further continue to receive the same dose for up to 44 weeks. |
|
| CagriSema in device 1 + Placebo in device 2 | Experimental | Participants will receive CagriSema in device 1 followed by placebo matched to CagriSema B in device 2 subcutaneously once weekly in a dose escalation manner for 16 weeks until the target maintenance dose and further continue to receive the same dose for up to 44 weeks. |
|
| Placebo in device 1 + Placebo in device 2 | Placebo Comparator | Participants will receive placebo matched to Cagrisema in device 1 followed by placebo matched to CagriSema B in device 2 subcutaneously once weekly for up to 44 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cagrisema | Drug | Cagrisema (Cagrilintide and Semaglutide) will be administered subcutaneously using device 1 or device 2. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Relative change in body weight | Measured in percentage (%). | From baseline (week 0) to end of treatment (week 44) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of TEAEs (treatment emergent adverse events) | Measured in count of events. | From baseline (week 0) to end of study (week 51) |
| Number of TESAEs (Treatment emergent serious adverse events) |
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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 |
|---|---|---|---|---|---|---|
| Uni of Alabama at Birmingham | Birmingham | Alabama | 35233 | United States | ||
| Cahaba Research |
According to the Novo Nordisk disclosure commitment on novonordisktrials.com
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Sponsor staff involved in the clinical trial is masked according to company standard procedures.
| Placebo CagriSema | Drug | Placebo matched to Cagrilintide and Placebo matched to Semaglutide will be administered subcutaneously using device 1 or device 2. |
|
Measured in count of events.
| From baseline (week 0) to end of study (week 51) |
| Pelham |
| Alabama |
| 35124 |
| United States |
| Advanced Investigative Medicine, Inc. | Hawthorne | California | 90250 | United States |
| Southern Cal Clinical Research | Santa Ana | California | 92701 | United States |
| Encompass Clinical Research_Spring Valley | Spring Valley | California | 91978 | United States |
| Chase Medical Research LLC | Waterbury | Connecticut | 06708 | United States |
| NextPhase Research | Hollywood | Florida | 33024 | United States |
| Oceane 7 Medical & Research Center, Inc. | Miami | Florida | 33144 | United States |
| ForCare Clinical Research | Tampa | Florida | 33613 | United States |
| EBGS Clinical Research Center, LLC | Snellville | Georgia | 30078 | United States |
| Rophe Adult & Pediatric Medicine | Union City | Georgia | 30291 | United States |
| Rocky Mountain Diabetes and Osteoporosis Center | Idaho Falls | Idaho | 83404 | United States |
| PGM Research of Christie Clinic | Champaign | Illinois | 61822 | United States |
| Arcturus HC PLC Troy Med Res | Troy | Michigan | 48098 | United States |
| Anointed Nephrology & HTN, LLC | Brookhaven | Mississippi | 39601 | United States |
| Palm Research Center Inc. | Las Vegas | Nevada | 89128 | United States |
| Palm Research Center Inc. | Las Vegas | Nevada | 89148 | United States |
| Weill Medical College of Cornell University | New York | New York | 10021 | United States |
| Alliance for Multispecialty Research | Norman | Oklahoma | 73069 | United States |
| Tribe Clinical Research LLC | Greer | South Carolina | 29650 | United States |
| Walker Family Care | Little River | South Carolina | 29566 | United States |
| Elligo Clin Res Centre | Austin | Texas | 78704 | United States |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390-9302 | United States |
| Forefront Med Res Inst PLLC | Harlingen | Texas | 78550 | United States |
| TPMG Clinical Research | Newport News | Virginia | 23606 | United States |
| Capital Clin Res Ctr,LLC | Olympia | Washington | 98502 | United States |
| IPSMC - Dr. Nikolay Kostadinov EOOD | Burgas | 8000 | Bulgaria |
| Medical Center Viva Feniks OOD | Dobrich | 9300 | Bulgaria |
| IPSOMC Dr. Miglena Rizova Ltd. | Kyustendil | 2500 | Bulgaria |
| UMHAT Pulmed OOD - Plovdiv, Department of Endocrinology | Plovdiv | 4002 | Bulgaria |
| UMHAT Sveti Georgi EAD, Plovdiv, Clinic of Endocrinology | Plovdiv | 4002 | Bulgaria |
| MHAT Sveta Karidad EAD | Plovdiv | 4004 | Bulgaria |
| DCC Iztok EOOD | Plovdiv | 4006 | Bulgaria |
| Medical Centre Razgrad OOD | Razgrad | 7200 | Bulgaria |
| DCC VII - Sofia EOOD, Endocrinology | Sofia | 1233 | Bulgaria |
| Diagnostic-Consultative Anti-Aging and Rejuvenation Center Hill Clinic EAD | Sofia | 1618 | Bulgaria |
| Medical Center Medical Plus EOOD | Varna | 9000 | Bulgaria |
| DCC Mladost - M Varna OOD | Varna | 9009 | Bulgaria |
| AIPSMC Dr. Artin Magardichyan EOOD | Varna | 9020 | Bulgaria |
| Sanos Clinic - Vejle | Vejle | Region Syddanmark | 7100 | Denmark |
| Sanos Clinic - Gandrup | Gandrup | 9362 | Denmark |
| Regionshospitalet Viborg - Karkirurgisk Afsnit | Viborg | 8800 | Denmark |
| 251 Air Force General Hospital - Department of Endocrinology & Diabetes | Athens | 11525 | Greece |
| General Hospital Of Athens G Gennimatas - Department of Endocrinology | Athens | 11527 | Greece |
| Laiko General Hospital Of Athens - A' Propaedeutic Clinic of Internal Medicine-Diabetes Centre | Athens | 11527 | Greece |
| Athens Medical Center S.A. (Iatriko Athinon) - Diabetes and Obesity Unit | Marousi | 15125 | Greece |
| Athens Medical Center S.A. (Iatriko P. Falirou) - Diabetes and Clinical Research Center | Palaió Fáliro | 17562 | Greece |
| General Hospital Of Thessaloniki G Gennimatas - Internal Medicine Clinic | Thessaloniki | 546 35 | Greece |
| Thermi Clinic S.A. - Diabetes and Internal Medicine Department | Thessaloniki | 57001 | Greece |
| Arina Trial Research Kft. | Orosháza | Bekes County | 5900 | Hungary |
| Szegedi Tudomanyegyetem St Györgyi Albert Klinikai Központ | Szeged | Csongrád-Csanád | 6725 | Hungary |
| Belinus Bt. | Debrecen | Hajdú-Bihar | 4025 | Hungary |
| Debreceni Egyetem | Debrecen | Hajdú-Bihar | 4032 | Hungary |
| Borbánya Praxis E.Ü. Kft. | Nyíregyháza | Szabolcs-Szatmar Varmegye | 4405 | Hungary |
| ClinDiab Egészségügyi Szolgáltató és Kereskedelmi Kft. | Budapest | 1089 | Hungary |
| Hospital Raja Perempuan Zainab II | Kota Bharu | Kelantan | 15586 | Malaysia |
| Hospital Canselor Tuanku Muhriz UKM | Cheras | Kuala Lumpur | 56000 | Malaysia |
| University Malaya Medical Centre | Lembah Pantai | Kuala Lumpur | 59100 | Malaysia |
| Hospital Seri Manjung | Seri Manjung | Perak | 32040 | Malaysia |
| Hospital Pulau Pinang | George Town | Pulau Pinang | 10990 | Malaysia |
| Hospital Miri | Miri | Sarawak | 98000 | Malaysia |
| Klinik Kesihatan Kuang | Rawang | Selangor | 48050 | Malaysia |
| University Technology MARA (UiTM) - Sg Buloh | Sungai Buloh | Selangor | 47000 | Malaysia |
| Klinik Kesihatan Kuala Kedah | Kuala Kedah | 05460 | Malaysia |
| Hospital Melaka | Malacca | 75400 | Malaysia |
| Hospital Queen Elizabeth II | Sabak Bernam | 88300 | Malaysia |
| Gabinet Leczenia Otylosci i Chorob Dietozaleznych | Bialystok | 15-281 | Poland |
| Centrum Medyczne Kermed Renata Bijata-Bronisz I Ewa Kowalinska Sp. j. | Bydgoszcz | 85-231 | Poland |
| Niepubliczny Zakład Opieki Zdrowotnej BIF-MED S.C. Arkadiusz Wawiernia, Mariola Roykiewicz, Rafał Roykiewicz | Bytom | 41-902 | Poland |
| NZOZ Mediart Centrum Zdrowia Matarnia | Gdansk | 80-298 | Poland |
| Synexus Polska Sp. z o.o. Oddzial w Gdansku | Gdansk | 80-382 | Poland |
| ID Clinic Arkadiusz Pisula | Mysłowice | 41-400 | Poland |
| Clinical Best Solutions Sp. z o.o., Sp. k | Warsaw | 00-710 | Poland |
| Synexus Polska Sp. z o.o. Oddzial w Warszawie | Warsaw | 02-672 | Poland |
| Kardio Life - Tomasz Borkowski | Włocławek | 87-800 | Poland |
| Velocity Nova Sp. z o.o. | Zamość | 22-400 | Poland |
| Prywatna Praktyka Lekarska Anna Chudoba | Żyrardów | 96-300 | Poland |
| ULS De Braga, E.P.E. - Hospital de Braga_Centro Clínico Académico | Braga | 4710-243 | Portugal |
| ULS Do Alto Ave, E.P.E - HSOG_Centro de Investigação Clínica | Guimarães | 4835-044 | Portugal |
| Hospital São Francisco, S.A_EECC | Leiria | 2400-110 | Portugal |
| APDP - Associação Protectora dos Diabéticos de Portugal | Lisbon | 1250-189 | Portugal |
| Affidea Montijo - UCardio | Montijo | 2870-100 | Portugal |
| Cardiolima Centro Diagnostico Cardio-Pulmonar De Ponte De Lima Lda | Ponte de Lima | 4990-029 | Portugal |
| Thera Card S.R.L | Brasov | 500102 | Romania |
| Kilostop Junior SRL | Bucharest | 010073 | Romania |
| SC Diamed Obesity SRL | Galati | 800291 | Romania |
| Arcadia Policlinic SRL | Iași | 700620 | Romania |
| Spital Judetean De Urgenta Satu Mare | Satu Mare | 440055 | Romania |
| SC Gensan SRL, Policlinica ASTRA | Sibiu | 550371 | Romania |
| Spitalul Clinic Judetean De Urgenta Targu Mures | Târgu Mureş | 540136 | Romania |
| MED-CENTRUM, s.r.o. | Martin | 036 01 | Slovakia |
| KARDIOMED NZ, s.r.o. | Nové Zámky | 940 01 | Slovakia |
| SVAJDLEROVA, s.r.o. | Prešov | 080 01 | Slovakia |
| ENRIN, s.r.o. | Rimavská Sobota | 979 01 | Slovakia |
| DIAB s.r.o. | Rožňava | 04801 | Slovakia |
| Soweto Clinical Trial Centre | Johannesburg | Gauteng | 1818 | South Africa |
| Ezintsha Research Centre | Johannesburg | Gauteng | 2193 | South Africa |
| Dr A Jacovides and Partners Inc | Midrand | Gauteng | 1685 | South Africa |
| Dr Vawda's site | Durban | KwaZulu-Natal | 4091 | South Africa |
| Dr T Padayachee | Durban | KwaZulu-Natal | 4170 | South Africa |
| Clinical Research Institute of South Africa | KwaDukuza | KwaZulu-Natal | 4449 | South Africa |
| Dr Moosa's Rooms | Gauteng | Lenasia | 1827 | South Africa |
| Luzerner Kantonsspital | Lucerne | 6004 | Switzerland |
| Kantonsspital Olten | Olten | 4600 | Switzerland |
| Stoffwechselzentrum St. Gallen | Sankt Gallen | 9016 | Switzerland |
| Diabetes Adipositas Zentrum Zürich | Zollikerberg | 8125 | Switzerland |
| Ditmanson Medical Foundation Chia-Yi Christian Hospital | Chiayi City | 600 | Taiwan |
| Kuang Tien General Hospital | Taichung | 433 | Taiwan |
| Chi Mei Medical Center | Tainan | 710 | Taiwan |
| Taipei Municipal Wan Fang Hospital_Division of Endocrinology & Metabolism | Taipei | 116 | Taiwan |
| Hat Yai hospital | Hat Yai | Changwat Songkhla | 90110 | Thailand |
| Ramathibodi Hospital | Bangkok | 10400 | Thailand |
| Siriraj Hospital | Bangkok | 10700 | Thailand |
| Maharaj Nakorn Chiang Mai | Chiang Mai | 50200 | Thailand |
| RIHES-CMU_Research Institute for Health Sciences | Chiang Mai | 50200 | Thailand |
| Thammasat Hospital_CRC | Pathum Thani | 12120 | Thailand |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| 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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