AMBITION 7: A Research Study Investigating How Well Zenagamtide Lowers Blood Sugar and Body Weight Compared to Insulin Glargine in People With Type 2 Diabetes and Increased Risk of Diseases That Affect the Heart and Blood Vessels Treated With 1-3 Other Diabetes Medications (AMBITION 7)
August 26, 2026 updated by: Novo Nordisk A/S
Efficacy and Safety of Zenagamtide s.c. Once Weekly Compared to Insulin Glargine s.c. Once Daily in Participants With Type 2 Diabetes and Increased Cardiovascular Risk Inadequately Controlled on 1-3 Oral Glucose-lowering Medications (AMBITION 7)
This study is being conducted to find out how well zenagamtide works and how safe it is compared to insulin glargine in participants with type 2 diabetes who are at higher risk of heart and blood vessel problems and are already taking 1 to 3 diabetes medications.
There are 2 study treatments in this study taken as injections under the skin once a week.
Participants will either get zenagamtide, (the treatment being tested) or insulin glargine (a comparator) and which treatment participants get is decided by chance.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
1778
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Novo Nordisk
- Phone Number: (+1) 866-867-7178
- Email: clinicaltrials@novonordisk.com
Study Locations
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Buenos Aires, Argentina, C1425AGC
- Not yet recruiting
- Centro Medico Dra. Laura Maffei e Investigacion Clínica Apli
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Buenos Aires, Argentina, C1015
- Not yet recruiting
- OMI- Organización Médica de Investigación
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Buenos Aires, Argentina, C1419
- Not yet recruiting
- Hospital Sirio Libanês
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CABA, Argentina, C1120AAC
- Not yet recruiting
- Centro Médico Viamonte SRL
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CABA, Argentina, C1061AAS
- Not yet recruiting
- CIPREC Arenales
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CABA, Argentina, C1440AAD
- Not yet recruiting
- CENUDIAB Centro Médico de Nutrición v Diabetes
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Córdoba, Argentina, X5008
- Not yet recruiting
- Centro Médico Privado CEMAIC
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Córdoba, Argentina, 5000
- Not yet recruiting
- Centro Diabetologico Cordoba Dr. Waitman
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Godoy Cruz, Argentina, M5501ARP
- Not yet recruiting
- CIPADI
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San Miguel de Tucumán, Argentina, T4000IHE
- Not yet recruiting
- Clínica Mayo de Urgencias Médicas Cruz Blanca
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Buenos Aires
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Bahía Blanca, Buenos Aires, Argentina, B8000
- Not yet recruiting
- Instituto de Investigaciones Clínicas Bahia Blanca
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CABA, Buenos Aires, Argentina, C1440CFD
- Not yet recruiting
- CEMEDIC
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Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1048
- Not yet recruiting
- Dolz Investigacion Clinica
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Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1426
- Not yet recruiting
- Fundación Respirar
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Mar del Plata, Buenos Aires, Argentina, B7600GNY
- Not yet recruiting
- Centro de Investigaciones Medicas Mar Del Plata
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Mendoza Province
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San Rafael, Mendoza Province, Argentina, M5602GGS
- Not yet recruiting
- CIMRO
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San Juan Province
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San Juan, San Juan Province, Argentina, J5400
- Not yet recruiting
- Centro Oncológico de Excelencia (COE)
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Santa Fe Province
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Rosario, Santa Fe Province, Argentina, S2000DEJ
- Not yet recruiting
- Fundacion Estudios Clinicos
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Rosario, Santa Fe Province, Argentina, S2000
- Not yet recruiting
- Nuvexa
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Sao Jose Rio Preto, Brazil, 15090-000
- Not yet recruiting
- Fundação Faculdade Regional de Medicina de São José do Rio Preto
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São Paulo, Brazil, 04266-010
- Not yet recruiting
- CEPIC - Centro Paulista de Investigacao Clinica
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Amazonas
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Manaus, Amazonas, Brazil, 69057-088
- Not yet recruiting
- CPHosp Manaus Medicina, Ensino e Pesquisa LTDA
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Ceará
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Fortaleza, Ceará, Brazil, 60135-270
- Not yet recruiting
- Instituto de Ensino e Pesquisa Clínica do Ceará Ltda
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Federal District
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Brasília, Federal District, Brazil, 70673-416
- Not yet recruiting
- CECAP - Centro de Cardiologia Clínica e Pesquisa Dra. Juliana Souza
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Goiás
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Aparecida de Goiânia, Goiás, Brazil, 74935-530
- Not yet recruiting
- Instituto de Ciências Farmacêuticas de Estudos e Pesquisas
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Goiânia, Goiás, Brazil, 74605-020
- Not yet recruiting
- Hospital Das Clinicas Da Universidade Federal De Goias
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Minas Gerais
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Uberlândia, Minas Gerais, Brazil, 38400-500
- Not yet recruiting
- Eurolatino Medical Research Center
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Paraná
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Curitiba, Paraná, Brazil, 80810-040
- Not yet recruiting
- Centro de Diabetes Curitiba
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Pará
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Belém, Pará, Brazil, 66073-000
- Not yet recruiting
- Hospital Universitário João de Barros Barreto - UFPA
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Rio de Janeiro
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Volta Redonda, Rio de Janeiro, Brazil, 27258-000
- Not yet recruiting
- Lóbus Centro de Pesquisa Clínica LTDA
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São Paulo
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Bragança Paulista, São Paulo, Brazil, 12916-542
- Not yet recruiting
- Associação Lar São Francisco de Assis na Providência de Deus - Bragança Paulista
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Campinas, São Paulo, Brazil, 13060-080
- Not yet recruiting
- Instituto de Pesquisa Clínica de Campinas
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Campinas, São Paulo, Brazil, 13092-133
- Not yet recruiting
- i9 Pesquisas Clínicas
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São Paulo, São Paulo, Brazil, 05403-000
- Not yet recruiting
- Instituto do Coração - HCFMUSP
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São Paulo, São Paulo, Brazil, 01223-001
- Not yet recruiting
- Instituto de Pesquisa Clinica (IPEC)
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São Paulo, São Paulo, Brazil, 01228-000
- Not yet recruiting
- CPQuali Pesquisa Clínica Ltda
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Burgas, Bulgaria, 8000
- Not yet recruiting
- Medical Center Diya Med EOOD
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Dimitrovgrad, Bulgaria, 6400
- Not yet recruiting
- MC Diamedical - 2013 OOD, Dimitrovgrad
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Dobrich, Bulgaria, 9300
- Not yet recruiting
- Medical Center Viva Feniks OOD
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Plovdiv, Bulgaria, 4030
- Not yet recruiting
- AIPSOMCEMD Dr. Velichka Zlatareva EOOD
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Smolyan, Bulgaria, 4700
- Not yet recruiting
- Medical center Smolyan clinical research OOD
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Sofia, Bulgaria, 1680
- Not yet recruiting
- Medical centre Vitclinic EOOD
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Stara Zagora, Bulgaria, 6000
- Not yet recruiting
- Prevencia - 2000 - MCOC OOD
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Yambol, Bulgaria, 8600
- Not yet recruiting
- MC Berbatov EOOD, Beli Drin
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Kyustendil
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Dupnitsa, Kyustendil, Bulgaria, 2600
- Not yet recruiting
- Medical centre Asclepius OOD
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Alberta
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Calgary, Alberta, Canada, T2H 2G4
- Not yet recruiting
- Centricity Research Calgary Endocrinology
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Edmonton, Alberta, Canada, T6G 2B7
- Not yet recruiting
- University of Alberta_Edmonton
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Red Deer, Alberta, Canada, T4P 1K4
- Not yet recruiting
- CARe Clinic Ltd.
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British Columbia
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Kelowna, British Columbia, Canada, V1Y 5A8
- Not yet recruiting
- Kelowna Health and Memory Centre Ltd.
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Kelowna, British Columbia, Canada, V1Y 4N7
- Not yet recruiting
- Medical Arts Health Research Group_Kelowna_0
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Nova Scotia
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Sydney, Nova Scotia, Canada, B1M 0A1
- Not yet recruiting
- Care Access Cape Breton
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Ontario
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Sarnia, Ontario, Canada, N7T 4X3
- Not yet recruiting
- Bluewater Clin Res Group Inc
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Stouffville, Ontario, Canada, L4A 1H2
- Not yet recruiting
- Stouffville Medical Research Institute
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Toronto, Ontario, Canada, M4G 3E8
- Not yet recruiting
- Centricity Research Toronto
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Quebec
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Terrebonne, Quebec, Canada, J6X 4P7
- Not yet recruiting
- Centre de Médecine Métabolique de Lanaudière
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Anhui
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Hefei, Anhui, China, 230012
- Not yet recruiting
- The Second People's Hospital of Hefei-Endocrinology
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Hefei, Anhui, China, 230061
- Not yet recruiting
- The Second Hospital of Anhui Medical University-Endocrinology
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Beijing Municipality
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Beijing, Beijing Municipality, China, 100044
- Not yet recruiting
- Peking University People's Hospital-Endocrinology
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Beijing, Beijing Municipality, China, 100037
- Not yet recruiting
- Chinese Academy of Medical Sciences Fuwai Hospital-Endocrinology
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Chongqing Municipality
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Chongqing, Chongqing Municipality, China, 400010
- Not yet recruiting
- The Second Affiliated Hospital of Chongqing Medical University-Endocrinology
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Chongqing, Chongqing Municipality, China, 404199
- Not yet recruiting
- Chongqing University Three Gorges Hospital-Endocrinology
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Guangdong
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Shenzhen, Guangdong, China, 518035
- Not yet recruiting
- The Second People's Hospital of Shenzhen-Endocrinology
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Hebei
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Cangzhou, Hebei, China, 061000
- Not yet recruiting
- Cangzhou People's Hospital-Endocrinology
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Langfang, Hebei, China, 065099
- Not yet recruiting
- Hebei PetroChina Central Hospital-Endocrinology
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Shijiazhuang, Hebei, China, 050000
- Not yet recruiting
- The Second Hospital of Hebei Medical University-Endocrinology
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Shijiazhuang, Hebei, China, 050023
- Not yet recruiting
- The First Hospital of Hebei Medical University-Endocrinology
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Henan
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Kaifeng, Henan, China, 475000
- Not yet recruiting
- Huaihe Hospital of Henan University-Endocrinology
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Luoyang, Henan, China, 471003
- Not yet recruiting
- The First Affiliated Hospital of Henan University of Science and Technology-Endocrinology
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Luoyang, Henan, China, 471002
- Not yet recruiting
- Luoyang First People's Hospital-Endocrinology
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Nanyang, Henan, China, 473058
- Not yet recruiting
- The First Affiliated Hospital of Nanyang Medical College-Endocrinology
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Zhengzhou, Henan, China, 450003
- Not yet recruiting
- The Second Affiliated Hospital of Zhengzhou University-Endocrinology
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Zhengzhou, Henan, China, 450052
- Not yet recruiting
- The First Affiliated Hospital of Zhengzhou University-Endocrinology
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Hubei
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Shiyan, Hubei, China, 442008
- Not yet recruiting
- Shiyan Taihe Hospital (Affiliated Hospital of Hubei University of Medicine)-Endocrinology
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Hunan
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Changde, Hunan, China, 415003
- Not yet recruiting
- The First People's Hospital of Changde City-Endocrinology
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Jiangsu
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Changzhou, Jiangsu, China, 213004
- Not yet recruiting
- The First People's Hospital of Changzhou-Endocrinology
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Changzhou, Jiangsu, China, 213164
- Not yet recruiting
- Changzhou No.2 People's Hospital-Endocrinology
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Nanjing, Jiangsu, China, 210011
- Not yet recruiting
- The Second Affiliated Hospital of Nanjing Medical University-Endocrinology
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Nanjing, Jiangsu, China, 210006
- Not yet recruiting
- Nanjing First Hospital-Endocriniology
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Nanjing, Jiangsu, China, 211199
- Not yet recruiting
- Nanjing Jiangning Hospital-Endocrinology
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Suzhou, Jiangsu, China, 215004
- Not yet recruiting
- The Second Affiliated Hospital of Soochow University-Endocrinology
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Zhenjiang, Jiangsu, China, 212001
- Not yet recruiting
- The Affiliated Hospital of Jiangsu University-Endocrinology
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Jilin
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Changchun, Jilin, China, 130061
- Not yet recruiting
- The First Bethune hospital of Jilin University-Endocrinology
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Jilin City, Jilin, China, 130041
- Not yet recruiting
- The Second Norman Bethune Hospital of Jilin University-Endocrinology
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Liaoning
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Panjin, Liaoning, China, 124120
- Not yet recruiting
- Panjin Liaoyou Gemflower Hospital-Endocrinology
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Qinghai
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Xining, Qinghai, China, 810007
- Not yet recruiting
- Qinghai Provincial People's Hospital-Endocrinology
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Shandong
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Jinan, Shandong, China, 250013
- Not yet recruiting
- Jinan Central Hospital-General Medicine
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Shanghai Municipality
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Shanghai, Shanghai Municipality, China, 201199
- Not yet recruiting
- Central Hospital of Minhang District, Shanghai-Endocrinology
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Sichuan
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Chengdu, Sichuan, China, 610071
- Not yet recruiting
- Sichuan Academy of Medical Science & Sichuan Provincial People's Hospital; Affiliated Hospital of UESTC-Endocrinology
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Zhejiang
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Huzhou, Zhejiang, China, 313000
- Not yet recruiting
- Huzhou Central Hospital-Endocrinology
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Brno, Czechia, 615 00
- Not yet recruiting
- EFERTUS healthcare s.r.o.
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Broumov, Czechia, 550 01
- Not yet recruiting
- Edumed s.r.o.
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Dolní Břežany, Czechia, 252 41
- Not yet recruiting
- Poliklinika Dolní Břežany
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Hradec Králové, Czechia, 500 02
- Not yet recruiting
- Medika Hradec Králové s.r.o.
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Náchod, Czechia, 547 01
- Not yet recruiting
- Edumed s.r.o.
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Ostrava, Czechia, 700 30
- Not yet recruiting
- MUDr. SRPOVÁ s.r.o.
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Ostrava, Czechia, 710 00
- Not yet recruiting
- Donmed s.r.o.
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Pardubice, Czechia, 530 02
- Not yet recruiting
- Pratia Pardubice a.s.
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Pilsen, Czechia, 326 00
- Not yet recruiting
- MUDr. Jitka Zemanova - diabetologie a interna, s.r.o.
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Prague, Czechia, 140 21
- Not yet recruiting
- IKEM
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Prague, Czechia, 140 00
- Not yet recruiting
- MEDICON a.s.
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Prague, Czechia, 17000
- Not yet recruiting
- Diantel s.r.o.
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Český Krumlov, Czechia, 381 01
- Not yet recruiting
- Nemocnice Český Krumlov, a.s.
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Deggingen, Germany, 73326
- Not yet recruiting
- Medizinisches Versorgungszentrum Jung GbR
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Essen, Germany, 45355
- Not yet recruiting
- Praxis am Markt Dr. Becker
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Gelnhausen, Germany, 63571
- Not yet recruiting
- MVZ Diabeteszentrum Dr. Tews GmbH
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Hamburg, Germany, 21109
- Not yet recruiting
- Diabetes-Zentrum-Wilhelmsburg GbR
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Hamburg, Germany, 22041
- Not yet recruiting
- Diabetes Zentrum Wandsbek Berufsausuebungsgemeinschaft GbR
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Hohenmölsen, Germany, 06679
- Not yet recruiting
- Dr. Milek medikum
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Jerichow, Germany, 39319
- Not yet recruiting
- Praxisgemeinschaft Jerichow
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Leipzig, Germany, 04249
- Not yet recruiting
- Gemeinschaftspraxis Dr. Täschner/Dr. Bonigut
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Ratingen, Germany, 40882
- Not yet recruiting
- Sanos Clinic GmbH Ratingen
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Athens, Greece, 115 27
- Not yet recruiting
- Laiko General Hospital Of Athens - 1st department of Internal Medicine
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Athens, Greece, 10676
- Not yet recruiting
- Evangelismos S.A. - Endocrinology department
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Athens, Greece, 115 25
- Not yet recruiting
- 251 Air Force General Hospital - Department of Endocrinology & Diabetes
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Athens, Greece, 11527
- Not yet recruiting
- General Hospital Of Athens G Gennimatas - Department of Endocrinology
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Efkarpia, Greece, 564 29
- Not yet recruiting
- General Hospital Of Thessaloniki Papageorgiou - 3rd Department of Internal Medicine
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Heraklion, Greece, 71500
- Not yet recruiting
- University General Hospital Of Heraklion - Nephrology Department
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Peristeri, Greece, 121 31
- Not yet recruiting
- Athens Medical Center S.A. (Iatriko Peristeriou) - Diabetes, obesity and cardiometabolic diseases department
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Rio, Patra, Greece, 26504
- Not yet recruiting
- General University Hospital of Patras,Nephrology clinic
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Thessaloniki, Greece, 546 42
- Not yet recruiting
- Ippokratio General Hospital Of Thessaloniki - 2nd Propaedeutic Department of Internal Medicine
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Thessaloniki, Greece, 546 42
- Not yet recruiting
- Ippokratio General Hospital Of Thessaloniki - B' Internal Medicine clinic
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Thessaloniki, Greece, 570 10
- Not yet recruiting
- Geniko Nosokomeio Thessalonikis George Papanikolaou - Internal Medicine and Diabetes Department
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Νikaia, Greece, 184 54
- Not yet recruiting
- Geniko Nosokomeio Nikaias Peiraia Ag. Panteleimon Geniko Nosokomeio Dytikis Attikis I - Nephrology Department
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Jaipur, India, 302004
- Not yet recruiting
- SMS Hospital
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New Delhi, India, 110029
- Not yet recruiting
- All India Institute of Medical Sciences (AIIMS)
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Andhra Pradesh
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Guntur, Andhra Pradesh, India, 522001
- Not yet recruiting
- Endolife Specialty Hospitals
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Chhattisgarh
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Raipur, Chhattisgarh, India, 492099
- Not yet recruiting
- All India Institute of Medical Sciences (AIIMS), Raipur
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Gujarat
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Surat, Gujarat, India, 395001
- Not yet recruiting
- Nirmal Hospital Pvt. Ltd.
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Vadodara, Gujarat, India, 390001
- Not yet recruiting
- SSG Hospital, Baroda
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Karnataka
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Bangalore, Karnataka, India, 560092
- Not yet recruiting
- Life Care Hospital and Research Centre
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Kerala
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Kochi, Kerala, India, 682041
- Not yet recruiting
- Amrita Institute Of Medical Sciences & Research Centre
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Kozhikode, Kerala, India, 673008
- Not yet recruiting
- Government Medical College, Kozhikode
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Madhya Pradesh
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Indore, Madhya Pradesh, India, 452010
- Not yet recruiting
- TOTALL Diabetes Hormone Institute
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Maharashtra
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Mumbai, Maharashtra, India, 400058
- Not yet recruiting
- BSES MG hospital
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Nagpur, Maharashtra, India, 440010
- Not yet recruiting
- Sunil's Diabetes Care n' Research Centre Pvt Ltd
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Pune, Maharashtra, India, 411021
- Not yet recruiting
- Chellaram Diabetes Institute
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Thane, Maharashtra, India, 421004
- Not yet recruiting
- Ashirwad Hospital and Research Centre
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Odisha
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Bhubaneswar, Odisha, India, 751019
- Not yet recruiting
- All India Institute of Medical Sciences (AIIMS), Bhubaneswar
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Punjab
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Ludhiana, Punjab, India, 141002
- Not yet recruiting
- Deep Healthcare Private Limited.
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Rajasthan
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Jaipur, Rajasthan, India, 302006
- Not yet recruiting
- Diabetes, Thyroid and Endocrine Centre
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Tamil Nadu
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Coimbatore, Tamil Nadu, India, 641018
- Not yet recruiting
- KG Hospital and PG Medical Institute & Research Centre
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Vellore, Tamil Nadu, India, 632004
- Not yet recruiting
- Christian Medical College Hospital, Vellore
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Telangana
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Hyderabad, Telangana, India, 500082
- Not yet recruiting
- Nizam's Institute of Medical Sciences
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Hyderabad, Telangana, India, 500012
- Not yet recruiting
- Osmania General Hospital_Hyderabad
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Milan, Italy, 20142
- Not yet recruiting
- ASST Santi Paolo e Carlo - Ospedale San Paolo - Diabetologia
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Abruzzo
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Chieti, Abruzzo, Italy, 66100
- Not yet recruiting
- Università degli studi G. D'Annunzio di Chieti - CAST - Centro Ricera Clinica (CRC)
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Calabria
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Catanzaro, Calabria, Italy, 88100
- Not yet recruiting
- AOU Renato Dulbecco - Unità Operativa Complessa Medicina Interna
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Campania
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Naples, Campania, Italy, 80131
- Not yet recruiting
- AOU Federico II Di Napoli - DAI Endocr. Diab. Andro. e Nutr. - UOC Endocrinologia Diabetologia e Andrologia
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Emilia-Romagna
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Ravenna, Emilia-Romagna, Italy, 48121
- Not yet recruiting
- AUSL Romagna - Medicine Specialistiche Ravenna - UO Servizio di Diabetologia di Ravenna
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Liguria
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Chiavari, Liguria, Italy, 16043
- Not yet recruiting
- Polo Ospedaliero di Chiavari - S.S.D. Diabetologia e Malattia Metaboliche
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Lombardy
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Milan, Lombardy, Italy, 20132
- Not yet recruiting
- Ospedale San Raffaele S.r.l. - Medicina Generale Indirizzo Diabetologico ed Endocrino-Metabolico
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RM
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Roma, RM, Italy, 00161
- Not yet recruiting
- Policlinico Umberto I Seconda Clinica Medica
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Tuscany
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Lucca, Tuscany, Italy, 55100
- Not yet recruiting
- AUSL Toscana Nord Ovest - Cittadella della Salute Campo di Marte - Diabetologia Lucca e Valle del Serchio
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Jalisco
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Guadalajara, Jalisco, Mexico, 44670
- Not yet recruiting
- Centro de Investigacion Clinica Endocrinologica de Jalisco
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Guadalajara, Jalisco, Mexico, 44600
- Not yet recruiting
- Instituto Jalisciense de Investigación en Diabetes y Obesidad
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Guadalajara, Jalisco, Mexico, 44600
- Not yet recruiting
- Diseño y Planeación en Investigación Médica S.C.
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Mexico City
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Tlalpan, Mexico City, Mexico, 14080
- Not yet recruiting
- Instituto Nacional de Ciencias Médicas y Nutrición
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Nuevo León
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Monterrey, Nuevo León, Mexico, 64020
- Not yet recruiting
- Alliance CEINV Salud S.A. de C.V.
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Sonora
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Hermosillo, Sonora, Mexico, 83280
- Not yet recruiting
- Investigación Médica Sonora S.C.
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Tamaulipas
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Ciudad Madero, Tamaulipas, Mexico, 89440
- Not yet recruiting
- Centro de Estudios de Investigación Metabólicos y Cardio
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Ciudad Madero, Tamaulipas, Mexico, 89450
- Not yet recruiting
- SIYODE S.A. de C.V. Unimeden
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Yucatán
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Merida Centro, Yucatán, Mexico, 97070
- Not yet recruiting
- Centro de Desarrollo Biomédico S.C.P.
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Mérida, Yucatán, Mexico, 97070
- Not yet recruiting
- Medical Care and Research S. A de C.V
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Bialystok, Poland, 15-351
- Not yet recruiting
- Osteo-Medic s.c. A. Racewicz, J. Supronik
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Bialystok, Poland, 15-481
- Not yet recruiting
- Kresmed Sp. z o. o.
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Bialystok, Poland, 15-269
- Not yet recruiting
- Uniwersytecki Szpital Kliniczny w Bialymstoku
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Bolesławiec, Poland, 59-700
- Not yet recruiting
- Zespol Opieki Zdrowotnej w Boleslawcu
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Chorzów, Poland, 41-516
- Not yet recruiting
- Diab Serwis Popenda Spółka Jawna
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Katowice, Poland, 40-600
- Not yet recruiting
- Gyncentrum Sp. z o. o.
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Libiąż, Poland, 32-590
- Not yet recruiting
- Centrum Medyczne MBB-MED Marta Blach-Burek
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Lodz, Poland, 90-132
- Not yet recruiting
- Gabinet Lekarski Malgorzata Saryusz-Wolska
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Lodz, Poland, 91-495
- Not yet recruiting
- Amicare Sp. z o.o. S.K.
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Lublin, Poland, 20-362
- Not yet recruiting
- Velocity Nova Sp. z o.o.
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Olsztyn, Poland, 10-117
- Not yet recruiting
- Etyka Osrodek Badan Klinicznych Tomasz Pesta S.K.A.
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Piotrkow Trybunalski, Poland, 97-300
- Not yet recruiting
- Irmed Klimkiewicz Rudziewicz-Kowalska sp. j.
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Poznan, Poland, 61-251
- Not yet recruiting
- Maciej Wiza Gaja Poradnie Lekarskie
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Poznan, Poland, 60-589
- Not yet recruiting
- Centrum Zdrowia Metabolicznego Paweł Bogdański
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Puławy, Poland, 24-100
- Not yet recruiting
- Velocity Nova Sp. z o.o.
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Rzeszów, Poland, 35-055
- Not yet recruiting
- Centrum Medyczne Medyk Sp.zo.o. Sp.k.
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Torun, Poland, 87-100
- Not yet recruiting
- Medicover Integrated Clinical Services Sp. z o.o.
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Warsaw, Poland, 02-507
- Not yet recruiting
- PANSTWOWY INSTYTUT MEDYCZNY MSWiA
-
Warsaw, Poland, 00-739
- Not yet recruiting
- Szpital Czerniakowski Sp. z o.o.
-
Wroclaw, Poland, 50-127
- Not yet recruiting
- Regionalna Poradnia Diabetologiczna-Zytkiewicz-Jaruga, Stasinska Spolka Partnerska Lekarzy
-
Zamość, Poland, 22-400
- Not yet recruiting
- Velocity Nova Sp. z o.o.
-
Żyrardów, Poland, 96-300
- Not yet recruiting
- Prywatna Praktyka Lekarska Anna Chudoba
-
-
Lublin Voivodeship
-
Lublin, Lublin Voivodeship, Poland, 20-601
- Not yet recruiting
- Zana-Med Medical Group Sp. z o.o.
-
-
Podlaskie Voivodeship
-
Bialystok, Podlaskie Voivodeship, Poland, 15-879
- Not yet recruiting
- NZOZ Vita-Diabetica Malgorzata Buraczyk
-
-
Silesian Voivodeship
-
Chorzów, Silesian Voivodeship, Poland, 41-500
- Not yet recruiting
- M2M Med. Badania Sp. z o.o.
-
-
-
-
-
A Coruña, Spain, 15006
- Not yet recruiting
- CHUAC_Endocrinología
-
Barcelona, Spain, 08035
- Not yet recruiting
- Hosp. Vall d'Hebrón_Endocrinología
-
Barcelona, Spain, 08036
- Not yet recruiting
- Clinic Barcelona_Endocrinología
-
Móstoles, Spain, 28935
- Not yet recruiting
- Hospital de Mostoles_Endocrinología
-
Sanlúcar de Barrameda, Spain, 11540
- Not yet recruiting
- H Virgen del Camino_Sanlúcar_Medicina Interna
-
Santiago de Compostela, Spain, 15706
- Not yet recruiting
- CHUS_Endocrinología
-
Segovia, Spain, 40002
- Not yet recruiting
- Hospital General de Segovia_Endocrinología
-
Valencia, Spain, 46014
- Not yet recruiting
- Hospital General de Valencia_Endocrinología
-
-
-
-
-
Adana, Turkey (Türkiye), 01060
- Not yet recruiting
- Adana Şehir Eğitim ve Araştırma Hastanesi
-
Adana /yüreği̇r, Turkey (Türkiye), 01240
- Not yet recruiting
- Başkent Üniversitesi Adana Dr. Turgut Noyan Uygulama ve Araştırma Merkezi -Endokrinoloji
-
Adapazarı/Turkiye, Turkey (Türkiye), 54100
- Not yet recruiting
- Sakarya Egitim ve Arastirma Hastanesi-Nefroloji
-
Afyonkarahisar, Turkey (Türkiye), 03200
- Not yet recruiting
- Afyonkarahisar Sağlık Bilimleri Üniversitesi Sağlık Uygulama Ve Araştırma Merkezi- Nefroloji
-
Ankara, Turkey (Türkiye), 06800
- Not yet recruiting
- Ankara Bilkent Şehir Hastanesi-Dahiliye
-
Gaziantep, Turkey (Türkiye), 27070
- Not yet recruiting
- Gaziantep Üniversitesi Hastanesi- Endokrinoloji
-
Istanbul, Turkey (Türkiye), 34722
- Not yet recruiting
- Göztepe Prof. Dr.Süleyman Yalçın Şehir Hastanesi- Dahiliye
-
Izmir, Turkey (Türkiye), 35100
- Not yet recruiting
- Ege Üniversitesi Tip Fakultesi Hastanesi - Nefroloji
-
Kayseri, Turkey (Türkiye), 38039
- Not yet recruiting
- Erciyes Üniversitesi Hastanesi- Kardiyoloji
-
Kocaeli, Turkey (Türkiye), 41380
- Not yet recruiting
- Kocaeli Üniversitesi Araştıma ve Uygulama Hastanesi - Nefroloji
-
Nilüfer/Bursa, Turkey (Türkiye), 16140
- Not yet recruiting
- Bursa Yüksek İhtisas Eğitim ve Araştırma Merkezi-Endokrinoloji
-
Odunpazarı /Eskişehir, Turkey (Türkiye), 26080
- Not yet recruiting
- Eskişehir Şehir Hastanesi- Kardiyoloji
-
Sivas, Turkey (Türkiye), 58140
- Not yet recruiting
- Sivas Cumhuriyet Üniversitesi Hastanesi -Endokrinoloji
-
Sur / Diyarbakır, Turkey (Türkiye), 21280
- Not yet recruiting
- Dicle Üniversitesi Tıp Fakültesi Sağlık Ve Araştırma Hastanesi- Nefroloji
-
-
Melikgazi
-
Kayseri, Melikgazi, Turkey (Türkiye), 38039
- Not yet recruiting
- Erciyes Üniversitesi Hastanesi - Nefroloji
-
-
-
-
-
Bristol, United Kingdom, BS10 5NB
- Not yet recruiting
- Southmead Hospital
-
Coventry, United Kingdom, CV2 2DX
- Not yet recruiting
- University Hospital Coventry - WISDEM Centre
-
Hull, United Kingdom, HU3 2JZ
- Not yet recruiting
- Hull Royal Infirmary - Diabetes
-
Ipswich, United Kingdom, IP4 5PD
- Not yet recruiting
- Ipswich Hospital - Diabetes
-
Londonderry, United Kingdom, BT47 6SB
- Not yet recruiting
- Altnagelvin Area Hospital
-
Swansea, United Kingdom, SA2 8PP
- Not yet recruiting
- Joint Clinical Research Facility - Swansea
-
Wallasey, United Kingdom, CH44 8AT
- Not yet recruiting
- Egremont Medical Centre
-
-
Cornwall
-
Newquay, Cornwall, United Kingdom, TR7 1RU
- Not yet recruiting
- North Coast Medical Ltd
-
-
Somerset
-
Yeovil, Somerset, United Kingdom, BA21 4AT
- Not yet recruiting
- Yeovil Hospital
-
-
South Yorkshire
-
Rotherham, South Yorkshire, United Kingdom, S65 1DA
- Not yet recruiting
- Clifton Medical Centre
-
-
-
-
Alabama
-
Birmingham, Alabama, United States, 35294
- Not yet recruiting
- Univ of Alabama Birmingham
-
Fairhope, Alabama, United States, 36532
- Recruiting
- Eastern Shore Rsrch Inst, LLC
-
Montgomery, Alabama, United States, 36106
- Recruiting
- Chambliss Clinical Trials, LLC
-
-
Arizona
-
Scottsdale, Arizona, United States, 85258
- Not yet recruiting
- Honor Health
-
-
California
-
Lancaster, California, United States, 93534
- Recruiting
- First Valley Medical Group
-
Lincoln, California, United States, 95648
- Recruiting
- Headlands Research CTR Lincoln
-
Lomita, California, United States, 90717
- Recruiting
- Torrance Clin Res Inst, Inc.
-
Los Alamitos, California, United States, 90720
- Recruiting
- Pacific Clinical Studies
-
Los Angeles, California, United States, 90073
- Not yet recruiting
- VAGLAHS Clinical Research Center (CRC)
-
Northridge, California, United States, 91325
- Recruiting
- Valley Clinical Trials, Inc.
-
San Diego, California, United States, 92108
- Recruiting
- Paradigm Clinical Research
-
San Dimas, California, United States, 91773
- Recruiting
- N America Res Inst - San Dimas
-
Spring Valley, California, United States, 91978
- Recruiting
- Encompass Clinical Research_Spring Valley
-
-
Florida
-
Clearwater, Florida, United States, 33756
- Recruiting
- Innovative Research of W FL
-
Crystal River, Florida, United States, 34429
- Not yet recruiting
- Nature Coast Clin Rsrch_Crystal River
-
Delray Beach, Florida, United States, 33484
- Not yet recruiting
- Florida Premier Cardiology
-
Hollywood, Florida, United States, 33024
- Recruiting
- Encore Medical Research LLC
-
Jacksonville, Florida, United States, 32216
- Not yet recruiting
- East Coast Institute For Research
-
Jacksonville, Florida, United States, 32216
- Not yet recruiting
- Jacksonville Ctr for Clin Res
-
Lakeland, Florida, United States, 33805
- Recruiting
- Clinical Research of Cent FL
-
Miami, Florida, United States, 33130
- Recruiting
- Life Spring Research Foundation LLC
-
Miami, Florida, United States, 33135
- Not yet recruiting
- Optimus U, Corp
-
Miami, Florida, United States, 33138
- Not yet recruiting
- Flourish Research - North Miami
-
Miami Lakes, Florida, United States, 33014
- Recruiting
- San Marcus Res Clin Miami Lakes
-
Miami Lakes, Florida, United States, 33014
- Not yet recruiting
- Inpatient Research Clinic LLC
-
Miramar, Florida, United States, 33027
- Recruiting
- Trujillo Medical Centers
-
New Port Richey, Florida, United States, 34652
- Not yet recruiting
- Suncoast Clinical Research, Inc.
-
Ocala, Florida, United States, 34471
- Recruiting
- Ocala Cardiovascular Research
-
Palm Harbor, Florida, United States, 34684
- Not yet recruiting
- Suncoast Clinical Research, Inc.
-
Pembroke Pines, Florida, United States, 33024
- Not yet recruiting
- Suncoast Research Associates LLC
-
Saint Augustine, Florida, United States, 32086
- Recruiting
- St Johns Center for Clin. Res
-
-
Georgia
-
Albany, Georgia, United States, 31707
- Recruiting
- Javara/Privia Med Grp GA,LLC
-
Cordele, Georgia, United States, 31015
- Not yet recruiting
- David Kavtaradze MD, Inc.
-
Tucker, Georgia, United States, 30084
- Not yet recruiting
- Atlanta Heart Specialist
-
-
Idaho
-
Idaho Falls, Idaho, United States, 83404
- Recruiting
- Rocky Mountain Diab&Osteo Ctr
-
-
Illinois
-
Gurnee, Illinois, United States, 60031
- Recruiting
- Elevate Clinical Research
-
Hazel Crest, Illinois, United States, 60429
- Recruiting
- Chicago Medical Research LLC
-
Oak Brook, Illinois, United States, 60523
- Not yet recruiting
- Genesis Orthopedics & Sports Medicine
-
Peoria, Illinois, United States, 61636
- Not yet recruiting
- Methodist Medical Center of Illinois
-
-
Indiana
-
Franklin, Indiana, United States, 46131
- Not yet recruiting
- American Health Network of IN LLC_Franklin
-
Greenfield, Indiana, United States, 46140
- Not yet recruiting
- American Health Network of Indiana, LLC_Greenfield
-
Muncie, Indiana, United States, 47304
- Not yet recruiting
- American Health Network of IN LLC
-
-
Iowa
-
Council Bluffs, Iowa, United States, 51501
- Recruiting
- West Broadway Clinic
-
Iowa City, Iowa, United States, 52772
- Not yet recruiting
- University of Iowa Prev Inter Ctr
-
West Des Moines, Iowa, United States, 50266
- Not yet recruiting
- Iowa Diab & Endo Res Center
-
-
Kansas
-
Topeka, Kansas, United States, 66606
- Recruiting
- Cotton O'Neil Diab & Endo Ctr
-
-
Kentucky
-
Lexington, Kentucky, United States, 40503
- Recruiting
- The Research Group of Lexington LLC
-
-
Louisiana
-
Covington, Louisiana, United States, 70433
- Not yet recruiting
- Louisiana Heart Center
-
-
Maryland
-
Baltimore, Maryland, United States, 21229
- Not yet recruiting
- Ascension Saint Agnes Heart Ca
-
Baltimore, Maryland, United States, 21239
- Not yet recruiting
- MedStar Good Samaritan Hosp
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Not yet recruiting
- Brigham & Women's Hospital
-
-
Michigan
-
Detroit, Michigan, United States, 48202
- Not yet recruiting
- Henry Ford Health System
-
Flint, Michigan, United States, 48532
- Recruiting
- Elite Research Center
-
Troy, Michigan, United States, 48098
- Recruiting
- Arcturus Healthcare, PLC.
-
Ypsilanti, Michigan, United States, 48197
- Not yet recruiting
- Trinity Health Michigan Heart
-
-
Missouri
-
Kansas City, Missouri, United States, 64112
- Not yet recruiting
- Johnson County ClinTrials
-
St Louis, Missouri, United States, 63128
- Recruiting
- Amicis Centers of Clinical Research
-
-
Nebraska
-
Omaha, Nebraska, United States, 68114
- Recruiting
- Methodist Phys. Clinic
-
-
Nevada
-
Las Vegas, Nevada, United States, 89128
- Not yet recruiting
- Palm Research Center Inc-Vegas
-
-
New York
-
Manlius, New York, United States, 13104
- Not yet recruiting
- Central New York Clinical Research CNYCR
-
New Windsor, New York, United States, 12553
- Recruiting
- Mid Hudson Med Res-New Windsor
-
New York, New York, United States, 10035
- Not yet recruiting
- Harlem Cardiology_Madison ave
-
The Bronx, New York, United States, 10451
- Not yet recruiting
- NYC Health + Hospitals/Lincoln
-
The Bronx, New York, United States, 10456
- Recruiting
- Prime Global Research Inc.
-
West Seneca, New York, United States, 14224
- Not yet recruiting
- Southgate Medical Group, LLP
-
-
North Carolina
-
Morehead City, North Carolina, United States, 28557
- Recruiting
- Carteret Medical Group
-
Statesville, North Carolina, United States, 28625
- Recruiting
- Piedmont Healthcare/Research
-
Winston-Salem, North Carolina, United States, 27103
- Recruiting
- Accellacare
-
-
Ohio
-
Cincinnati, Ohio, United States, 45267
- Not yet recruiting
- Univ of Cincinnati Med Cent
-
Maumee, Ohio, United States, 43537
- Recruiting
- Advanced Med Res Maumee
-
-
Oklahoma
-
Norman, Oklahoma, United States, 73072
- Recruiting
- Lynn Institute of Norman
-
-
Pennsylvania
-
Beaver, Pennsylvania, United States, 15009
- Not yet recruiting
- Heritage Valley Medical Group
-
Newport, Pennsylvania, United States, 17074
- Recruiting
- Capital Area Research LLC
-
-
South Carolina
-
Fort Mill, South Carolina, United States, 29707
- Recruiting
- Piedmont Research Partners, LLC
-
Mt. Pleasant, South Carolina, United States, 29464
- Not yet recruiting
- Accellacare US Inc._SC
-
Myrtle Beach, South Carolina, United States, 29572
- Recruiting
- Trial Management Associates
-
-
Tennessee
-
Bristol, Tennessee, United States, 37620-7352
- Recruiting
- Holston Medical Group Pc
-
Knoxville, Tennessee, United States, 37909
- Not yet recruiting
- The Alliance for Multispecialty Research LLC AMR
-
Nashville, Tennessee, United States, 37203
- Recruiting
- MidState Endocrine Associates
-
-
Texas
-
Amarillo, Texas, United States, 79106
- Not yet recruiting
- PharmaTex Research
-
Austin, Texas, United States, 78757
- Not yet recruiting
- Pinnacle Clinical Research
-
Conroe, Texas, United States, 77384
- Recruiting
- Javara Inc. / Privia Medical Group Gulf Coast PLLC
-
Corpus Christi, Texas, United States, 78414
- Not yet recruiting
- Osvaldo A. Brusco MD
-
Dallas, Texas, United States, 75208
- Recruiting
- Thyroid Endocrinology & Diabetes PA
-
Dallas, Texas, United States, 75226
- Not yet recruiting
- Baylor Jack and Jane Hamilton
-
Fort Worth, Texas, United States, 76132
- Not yet recruiting
- Diabetes and Thyroid Ctr of FW
-
Houston, Texas, United States, 77024
- Recruiting
- PrimeCare Medical Group
-
Houston, Texas, United States, 77043
- Recruiting
- Biopharma Informatic_Houston
-
Houston, Texas, United States, 77040
- Recruiting
- JCCT- Juno NW Houston
-
Houston, Texas, United States, 77070
- Recruiting
- Northwest Houston Cardiology, P.A.
-
Houston, Texas, United States, 77095
- Not yet recruiting
- Endocrine And Psychiatry Center
-
Katy, Texas, United States, 77493
- Recruiting
- Prem Internal Med Asso Houston
-
Longview, Texas, United States, 75605
- Recruiting
- DCOL Ctr for Clin Res
-
Lufkin, Texas, United States, 75904
- Recruiting
- Texas Inst, Kdny & Endo Disor
-
Mesquite, Texas, United States, 75149
- Not yet recruiting
- PRX Research
-
San Antonio, Texas, United States, 78230
- Recruiting
- VIP Trials
-
San Antonio, Texas, United States, 78233
- Recruiting
- NE Clin Res of San Antonio
-
San Antonio, Texas, United States, 78229
- Not yet recruiting
- Univ Of Texas Hlth Science Cntr
-
San Antonio, Texas, United States, 78212
- Recruiting
- Clinical Advancement Center
-
San Antonio, Texas, United States, 78229
- Not yet recruiting
- The IMA Group IMA Clinical Trials of America Inc. CTA
-
Sugar Land, Texas, United States, 77478
- Recruiting
- Simcare Medical Research, LLC
-
Weslaco, Texas, United States, 78596
- Not yet recruiting
- Valley Diab. & Endo Comp Ctr
-
-
Utah
-
Bountiful, Utah, United States, 84010
- Not yet recruiting
- Progressive Clinical Research UT
-
Layton, Utah, United States, 84041
- Recruiting
- Alpine Research Association
-
Salt Lake City, Utah, United States, 84107
- Not yet recruiting
- Wasatch Clinical Research, LLC
-
-
Virginia
-
Manassas, Virginia, United States, 20109
- Not yet recruiting
- Carient Heart and Vascular
-
Richmond, Virginia, United States, 23219
- Not yet recruiting
- Dominion Medical Associates
-
Salem, Virginia, United States, 24153
- Not yet recruiting
- VA Medical Center_Salem
-
Winchester, Virginia, United States, 22601-3834
- Recruiting
- Selma Medical Associates
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
- Male or female (sex assigned at birth, inclusive of all gender identities).
- Age 45 years or above at the time of signing the informed consent.
- Diagnosed with type 2 diabetes (T2D) greater than or equal to (≥) 180 days before screening.
- Treatment with 1-3 marketed oral glucose-lowering medications (metformin, glinide, thiazolidinedione, sodium-glucose cotransporter-2 inhibitors (SGLT2i), α-glucosidase inhibitors (AGI), or sulfonylureas (SU) as a single agent or in combination) according to local label. Treatment with oral glucose-lowering medications must be stable (same drug(s), stable daily dose(s)) before screening.
- Have HbA1c as determined by central laboratory at screening, if background glucose-lowering medications does not include a SU, or if background glucose-lowering medications includes a SU.
- Increased risk of cardiovascular events as evidenced by at least one of the following (a-e):
- Prior myocardial infarction (MI)
Documented coronary artery disease defined by at least one of the following:
-≥ 50% stenosis of coronary artery on angiography or other imaging modality.
- Ischaemia documented by stress test with any imaging modality.
- Prior unstable angina with electrocardiogram (ECG) changes.
- Prior coronary artery bypass graft or prior percutaneous coronary intervention.
- Prior stroke (ischemic or haemorrhagic stroke).
- History of chronic kidney disease based on medical records or as judged by the investigator as determined by central laboratory at screening.
- Symptomatic peripheral arterial disease (PAD) defined as at least one of the following:
- Intermittent claudication with an ankle-brachial index (ABI) < 0.85 at rest.
- Intermittent claudication with a ≥ 50% stenosis in a lower extremity peripheral artery documented by X-ray angiography, magnetic resonance (MR) angiography, computer tomography (CT) angiography or Doppler ultrasound.
- Prior revascularisation procedure of a lower extremity peripheral artery.
- Lower extremity amputation at or above ankle due to atherosclerotic disease (excluding e.g., trauma or osteomyelitis)
Exclusion Criteria:
- Myocardial infarction, stroke, transient ischaemic attack or hospitalisation for unstable angina pectoris within 60 days before screening.
- Planned coronary, carotid or peripheral artery revascularisation.
- Chronic or intermittent haemodialysis or peritoneal dialysis within 90 days before screening.
Diabetes- or weight related:
- Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria before screening. However, insulin treatment for gestational diabetes is allowed as well as short term insulin treatment for a maximum of 14 consecutive days.
- Treatment with glucagon-like-peptide-1 (GLP-1) receptor agonists (RA), dual GLP1/gastric inhibitory peptide (GIP) RAs (or any other GLP-1 based treatment), dipeptidyl peptidase 4 (DPP-4) inhibitors or amylin analogues before screening.
- Participant with diabetic retinopathy or maculopathy who received treatment with retinal photocoagulation, vitrectomy or anti-Vascular Endothelial Growth Factor (anti-VEGF) within 180 days before screening or are expected to require treatment within 180 days after screening. Diabetic retinopathy or maculopathy must be verified by an eye examination performed before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
- Known hypoglycaemic unawareness as indicated by the investigator according to Clarke's questionnaire question.
- Any episodes of diabetic ketoacidosis before screening.
- Uncontrolled thyroid disease as per investigator's discretion.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Zenagamtide
Participants will receive zenagamtide subcutaneously once weekly to one of the body parts: thigh, abdomen or upper arm.
|
Zenagamtide will be administered subcutaneously using PDS290 pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm (administration to the same body part throughout the study).
|
|
Active Comparator: Insulin glargine U-100
Participants will receive Insulin glargine U-100 subcutaneously once daily to one of the body parts: thigh, abdomen or upper arm.
|
Insulin glargine U-100 will be administered subcutaneously using SoloSTAR pen-injector to one of the body parts: thigh, abdomen or upper arm (rotation of the injection site within body parts).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Non-inferiority of zenagamtide versus insulin glargine: change in haemoglobin A1c (HbA1c)
Time Frame: From baseline (week 0) to week 52
|
Measured as percentage (%)-points
|
From baseline (week 0) to week 52
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to first occurrence of a 4-point major adverse cardiovascular events (MACE) endpoint consisting of: Cardiovascular (CV) death, non-fatal myocardial infarction, non-fatal stroke and hospitalisation for unstable angina
Time Frame: From baseline (week 0) to 104 weeks or more
|
Measured as days
|
From baseline (week 0) to 104 weeks or more
|
|
Relative change in body weight
Time Frame: From baseline (week 0) to week 52
|
Measured as percentage (%) change
|
From baseline (week 0) to week 52
|
|
Superiority of zenagamtide versus insulin: Change in HbA1c
Time Frame: From baseline (week 0) to week 52
|
Measured as %-points
|
From baseline (week 0) to week 52
|
|
Time to first occurrence of a 3-point MACE endpoint consisting of: CV death, non-fatal myocardial infarction and non-fatal stroke
Time Frame: From baseline (week 0) to 104 weeks or more
|
Measured as Days
|
From baseline (week 0) to 104 weeks or more
|
|
Change in waist circumference
Time Frame: From baseline (week 0) to week 52
|
Measured as centimeters
|
From baseline (week 0) to week 52
|
|
Change in systolic blood pressure
Time Frame: From baseline (week 0) to week 52
|
Measured as millimeters of mercury (mmHg)
|
From baseline (week 0) to week 52
|
|
Change in high-sensitivity C-reactive protein (hsCRP)
Time Frame: From baseline (week 0) to week 52
|
Measured as ratio to baseline
|
From baseline (week 0) to week 52
|
|
Change in Triglycerides
Time Frame: From baseline (week 0) to week 52
|
Measured as ratio to baseline
|
From baseline (week 0) to week 52
|
|
Change in Non-high-density lipoprotein (non-HDL) cholesterol
Time Frame: From baseline (week 0) to week 52
|
Measured as ratio to baseline
|
From baseline (week 0) to week 52
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 24, 2026
Primary Completion (Estimated)
July 31, 2028
Study Completion (Estimated)
September 20, 2028
Study Registration Dates
First Submitted
August 26, 2026
First Submitted That Met QC Criteria
August 26, 2026
First Posted (Actual)
September 1, 2026
Study Record Updates
Last Update Posted (Actual)
September 1, 2026
Last Update Submitted That Met QC Criteria
August 26, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NN9490-8665
- U1111-1333-6446 (Other Identifier: UTN Number)
- 2026-525209-11 (Other Identifier: European Medical Agency (EMA))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
According to the Novo Nordisk disclosure commitment on novonordisktrials.com
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.