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Clinical Trial Details

Trial ID: L1161
Source ID: NCT06131372
Associated Drug: Cagrilintide
Title: A Research Study to See if Kidney Damage in People With Chronic Kidney Disease and Type 2 Diabetes Living With Overweight or Obesity Can be Reduced by CagriSema Compared to Semaglutide, Cagrilintide and Placebo
Acronym:
Status: ACTIVE_NOT_RECRUITING
Study Results: NO
Results:
Conditions: Chronic Kidney Disease|Type 2 Diabetes|Obesity
Interventions: DRUG: Cagrilintide|DRUG: Semaglutide|DRUG: Placebo
Outcome Measures: Primary: Change in urinary albumin-to-creatinine ratio (UACR), Measured in ratio to baseline., From baseline (week 0) to end of treatment (week 26) | Secondary: 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), 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)
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 618
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-04-01
Completion Date: 2025-12-01
Results First Posted:
Last Update Posted: 2025-04-09
Locations: John Muir Physicians Network, Concord, California, 94520, United States|Desert Oasis Hlthcr Med Group, Palm Springs, California, 92262, 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, Miami, Florida, 33130, United States|Florida Hospital 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 Neph Associates, Mineola, New York, 11501, United States|New York University 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 Nephr Assoc, 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 Medical Group Inc, Beaver, Pennsylvania, 15009, United States|Main Street Physician's Care, Little River, South Carolina, 29566, United States|Osvaldo A. Brusco MD PA, Corpus Christi, Texas, 78414, United States|Southwest Houston Research Ltd, Houston, Texas, 77099, United States|Clinical Advancement Ctr, PLLC, San Antonio, Texas, 78212, United States|Clinical Inv Spec, Inc.Kenosha, Kenosha, Wisconsin, 53144, United States|Mautalen Salud e investigación, Caba, Buenos Aires, C1128 AAF, Argentina|Centro de Investigaciones Médicas Clínica de Fracturas y Or, Mar del Plata, Buenos Aires, B7600GNY, Argentina|Fundación CESIM, Santa Rosa, La Pampa, 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, Parana, 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, Sao Paulo, 01228-200, Brazil|Hospital do Rim e Hipertensao Fundacao Oswaldo Ramos, Sao Paulo, 04038-002, Brazil|Centricity Research Brampton, Brampton, Ontario, L6S 0C6, Canada|Centricity Research Vaughn, Concord, Ontario, L4K 4M2, Canada|Centricity Research Etobicoke, Etobicoke, Ontario, M9R 4E1, Canada|Hamilton Medical Rsrch Grp, Hamilton, Ontario, L81 5G4, Canada|Bluewater Clin Res Group Inc, Sarnia, Ontario, N7T 4X3, Canada|UHN-Toronto General Hospital, Toronto, Ontario, M5G 2N2, Canada|Ctr de rech Clin de Laval, Laval, Quebec, H7T 2P5, Canada|Centre Medical Acadie, Montreal, Quebec, H4N 2W2, Canada|Groupe Sos Sante-Hopital Le Creusot-Hotel Dieu-1, Le Creusot, 71200, France|Gie Groupe Hospitalier Paris Saint-Joseph/Vinci, Paris Cedex 14, 75674, France|Centre Hospitalier Universitaire de Poitiers, Poitiers, 86000, France|Centre Hospitalier Universitaire Reims-Hopital Maison Blanche, Reims cedex, 51092, France|Centre Hospitalier Universitaire de Nantes-Hopital Nord Laennec-1, Saint Herblain, 44800, France|Centre Hospitalier Universitaire de Toulouse-Hopital Rangueil-1, Toulouse Cedex 9, 31059, France|Centre de Recherche Clinique Portes Du Sud, Venissieux, 69200, France|Periphery University Hospital of Heraklion, Heraklion / Crete, 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|Univ Gen Hospital Larisa, Endocrinology & Metabolic Disease, Larissa, GR-41110, Greece|General University Hospital of Patras,Nephrology clinic, Patra, 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 Vármegye, 6500, Hungary|Belinus Bt., Debrecen, Hajdu-Bihar Varmegye, 4025, Hungary|Siófoki Kórház, Diabetológiai Szakrendelés, Siófok, Somogy Vármegye, 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, Koriyama-shi, 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, 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, Tokyo, 103-0027, Japan|Fukuwa Clinic, Tokyo, 104-0031, Japan|Osteo Medic s.c. Artur Racewicz Jerzy Supronik, Bialystok, Podlaskie, 15-351, Poland|NZOZ Specjalistyczny Osrodek Internistyczno-Diabetologiczny Małgorzata Arciszewska, Bialystok, Podlaskie, 15-435, Poland|Kresmed Sp. z o. o., Bialystok, Podlaskie, 15-481, Poland|M2M Med. Sp. z o.o. Sp. j., Chorzow, Slaskie, 41-500, Poland|M2M Med. Sp. z o.o. Sp. j., Chorzow, 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 Ośrodek Badań 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, Warszawa, 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., Kosice, 040 01, Slovakia|Univerzitna nemocnica L. Pasteura Kosice, Kosice, 040 01, Slovakia|Vysokospecializovany odborny ustav geriatricky sv. Lukasa v Kosiciach, n.o., Kosice, 040 01, Slovakia|Tatratrial s.r.o., Roznava, 048 01, Slovakia|Hospital Universitario Puerta de Hierro Majadahonda, Majadahonda, Madrid, 28222, Spain|Hospital Fundación Alcorcón, Alcorcon, 28922, Spain|Hospital Vall d'Hebron, Barcelona, 08035, Spain|Hospital de Bellvitge, Hospitalet de Llobregat, 08907, Spain|Hospital Universitario de Canarias, Santa Cruz de Tenerife, 38320, Spain|Hospital Clínico Universitario de Valencia, Valencia, 46010, Spain|Siriraj Hospital, Bangkok Noi, Bangkok, 10700, Thailand|King Chulalongkorn Memorial Hospital, Patumwan, Bangkok, 10330, Thailand|Maharaj Nakorn Chiang Mai Hospital, Chiang Mai, Mueang Chiang Mai, 50200, Thailand|Thammasat University Hospital, Klong Luang, Pathum Thani, 12120, Thailand|Phramongkutklao Hospital, Bangkok, 10400, Thailand|Siriraj Hospital, Bangkok, 10700, Thailand
URL: https://clinicaltrials.gov/show/NCT06131372

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress