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AMAZE 8: A Research Study Investigating How Well the Medicine NNC0487-0111 Compared to Semaglutide Helps People With Excess Body Weight and Type 2 Diabetes Lose Weight
Sponsor: Novo Nordisk A/S
Summary
The purpose of this clinical study is to find out if NNC0487-0111 is safe and effective for treating people who have excess body weight and type 2 diabetes. Participant will receive 2 injections every week: an active medicine and a placebo, both taken as injections under the skin once a week. The placebo is a treatment with no active medicine in it and will be given to all participants. In addition to placebo, participants will receive either of the active medicine NNC0487-0111 (the treatment being tested) or Semaglutide (an approved and commonly prescribed treatment used as comparator). Which treatment participants get is decided by chance.
Official title: Efficacy and Safety of NNC0487-0111 s.c. Once-weekly Compared to Semaglutide s.c. Once-weekly in Participants With Overweight or Obesity, and Type 2 Diabetes (AMAZE 8)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1000
Start Date
2026-05-20
Completion Date
2029-01-26
Last Updated
2026-03-12
Healthy Volunteers
No
Interventions
NNC0487-0111
NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.
Semaglutide
Semaglutide will be administered subcutaneously using PDS290 pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.
Placebo (matched to NNC0487-0111)
Placebo matched to NNC0487-0111 will be administered subcutaneously using pre- filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.
Placebo (matched to semaglutide)
Placebo matched to semaglutide will be administered subcutaneously using pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.
Locations (120)
Encore Medical Research LLC
Hollywood, Florida, United States
Optimal Research Sites
Orange City, Florida, United States
Encore Medical Research of Weston
Weston, Florida, United States
Endocrine Research Solutions, Inc
Roswell, Georgia, United States
Elite Clinical Trials
Blackfoot, Idaho, United States
Endo And Metab Cons
Rockville, Maryland, United States
Arcturus Healthcare, PLC.
Troy, Michigan, United States
Velocity Clin Res, Dallas
Dallas, Texas, United States
Consano Clinical Research, LLC
Shavano Park, Texas, United States
Selma Medical Associates
Winchester, Virginia, United States
Centro de Investigaciones Metabólicas
Capital Federal, Buenos Aires, Argentina
Centro Médico CIMEL
Lanús Este, Buenos Aires, Argentina
Centro Médico Privado San Vicente Diabetes
Córdoba, Argentina
Núcleo de Pesquisa Clínica do Rio Grande do Sul Ltda.
Porto Alegre, Rio Grande do Sul, Brazil
i9 Pesquisas Clínicas
Campinas, São Paulo, Brazil
CPQuali Pesquisa Clínica Ltda
São Paulo, São Paulo, Brazil
BR Trials - Ensaios Clínicos e Consultoria Ltda.
São Paulo, São Paulo, Brazil
Dr. Tatyana Metalova - AIPSMCE EOOD
Gotse Delchev, Bulgaria
Medical centre Zdrave 1 OOD
Kozloduy, Bulgaria
UMHAT Pulmed OOD - Pazardzhik, Department of Internal Diseases
Pazardzhik, Bulgaria
MHAT Heart and Brain EAD - Pleven, Endocrinology and Metabolic Diseases
Pleven, Bulgaria
DCC I- Pleven EOOD Endocrinology
Pleven, Bulgaria
MHAT Knyaginya Klementina - Sofia EAD
Sofia, Bulgaria
MHAT Sveta Sofia EOOD, Department of Endocrinology and Metabolic diseases
Sofia, Bulgaria
Acibadem City Clinic UMHAT Tokuda EAD, Endocrinology
Sofia, Bulgaria
USHATE Akad. Ivan Penchev EAD, Second Clinic of Endocrinology
Sofia, Bulgaria
Medical Institute of Ministry of interior
Sofia, Bulgaria
Medical Centre - Clinic Nova EOOD
Varna, Bulgaria
Poliklinika Medikol Zagreb
Grad Zagreb, Croatia
Opca bolnica Karlovac
Karlovac, Croatia
Specijalna Bolnica za medicinsku rehabilitaciju Krapinske Toplice_Endocrinology
Krapinske Toplice, Croatia
Poliklinika SLAVONIJA OSIJEK
Osijek, Croatia
Clinical Hospital Centre Rijeka_Endocrinology
Rijeka, Croatia
General Hospital Dr. Josip Bencevic_Diabetic department
Slavonski Brod, Croatia
Opca bolnica Varazdin_Endocrinology
Varaždin, Croatia
Poliklinika Solmed
Zagreb, Croatia
Herz- und Diabeteszentrum NRW - Bad Oeynhausen
Bad Oeynhausen, Germany
Zentrum fuer klinische Studien Suedbrandenburg GmbH
Elsterwerda, Germany
Praxis am Markt Dr. Becker
Essen, Germany
MVZ im Altstadt-Carree Fulda GmbH - Zentrum für klinische Studien
Fulda, Germany
Diabetes-Zentrum-Wilhelmsburg GbR
Hamburg, Germany
Diabetologische Gemeinschaftspraxis Dr. Staudenmeyer und Dr. Schiwietz
Lingen, Germany
SMO.MD GmbH - Zentrum für klinische Studien
Magdeburg, Germany
Institut für Diabetesforschung Osnabrück
Osnabrück, Germany
ceda - Centrum für Diabetologie und Allgemeinmedizin Pohlheim
Pohlheim, Germany
Forschungszentrum Ruhr KliFoCenter GmbH, Kahrmann
Witten, Germany
Debreceni Egyetem
Debrecen, Hajdú-Bihar, Hungary
Komáromi Selye János Kórház
Komárom, Komárom-Esztergom, Hungary
Óbudai Egészségügyi Centrum
Budapest, Pest County, Hungary
Borbánya Praxis E.Ü. Kft.
Nyíregyháza, Szabolcs-Szatmar Varmegye, Hungary
Békés Vármegyei Központi Kórház
Gyula, Hungary
Endolife Specialty Hospitals
Guntur, Andhra Pradesh, India
Nirmal Hospital Pvt. Ltd.
Surat, Gujarat, India
SSG Hospital, Baroda
Vadodara, Gujarat, India
Diacon Hospital Private Limited
Bangalore, Karnataka, India
Lifecare Hospital and Research Centre
Bengaluru, Karnataka, India
Amrita Institute Of Medical Sciences & Research Centre
Kochi, Kerala, India
TOTALL Diabetes Hormone Institute
Indore, Madhya Pradesh, India
BSES MG hospital
Mumbai, Maharashtra, India
Shalini Tai Meghe Hospital and Research Center
Nagpur, Maharashtra, India
Chellaram Diabetes Institute
Pune, Maharashtra, India
SMS Medical College & Hospital
Jaipur, Rajasthan, India
Diabetes, Thyroid and Endocrine Centre
Jaipur, Rajasthan, India
Arthur Asirvatham hospital,
Madurai, Tamil Nadu, India
NIZAM'S Institute of Medical Sciences
Hyderabad, Telangana, India
IPGME&R and SSKM Hospital
Kolkata, West Bengal, India
Rajiv Gandhi Centre for Diabetes and Endocrinology, J.N Medical College, Aligarh Muslim University
Aligarh, India
All India Institute of Medical Sciences (AIIMS)
New Delhi, India
Jothydev's Diabetes & Research Center
Thriruvananthapuram, India
Diseño y Planeación en Investigación Médica S.C.
Guadalajara, Jalisco, Mexico
Alliance CEINV Salud S.A. de C.V.
Monterrey, Nuevo León, Mexico
Centro de Estudios de Investigación Metabólicos y Cardio
Ciudad Madero, Tamaulipas, Mexico
Gabinety Medyczne MATUSZEK Beata Matyjaszek-Matuszek Prywatna Praktyka Specjalistyczna
Lublin, Lesser Poland Voivodeship, Poland
EKAMED sp. z o.o.
Lublin, Lublin Voivodeship, Poland
Przychodnie Grudziadz Sp. z o. o.
Grudziądz, Mazovian Voivodeship, Poland
Legeartis Poradnie Specjalistyczne Sp. z o.o.
Bialystok, Podlaskie Voivodeship, Poland
NZOZ Specjalistyczny Osrodek Internistyczno-Diabetologiczny Małgorzata Arciszewska
Bialystok, Poland
NZOZ Vita-Diabetica Malgorzata Buraczyk
Bialystok, Poland
Centrum Kliniczno-Badawcze J.Brzezicki B.Gornikiewicz-Brzezicka Lekarze sp.p.
Elblag, Poland
Specjalistyczny Gabinet Diabetologiczny Radoslaw Rumianowski
Gorzów Wielkopolski, Poland
SP ZOZ w Kalwarii Zebrzydowskiej
Kalwaria Zebrzydowska, Poland
Linden sp. z o.o. sp. k.
Krakow, Poland
Diamond Clinic sp zoo
Krakow, Poland
Beata Miklaszewicz & Dariusz Dabrowski "CARDIAMED" s.j.
Legnica, Poland
Serce Sp. z o.o.
Leszno, Poland
Gabinet Lekarski Malgorzata Saryusz-Wolska
Lodz, Poland
Centrum Terapii Wspolczesnej - J.M. Jasnorzewska S.K.A.
Lodz, Poland
Niepubliczny Zaklad Opieki Zdrowotnej Przychodnia Specjalistyczna A Wittek H Rudzki Sp. j.
Ruda Śląska, Poland
Lukmed 2 Sp. z o.o.
Siedlce, Poland
Szpital Czerniakowski Sp. z o.o.
Warsaw, Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Szyszko
Zabrze, Poland
Prywatna Praktyka Lekarska Anna Chudoba
Żyrardów, Poland
Hospital de Cascais
Alcabideche, Portugal
ULS Almada-Seixal E.P.E. - Hospital Garcia de Orta
Almada, Portugal
ULS De Braga, E.P.E. - Hospital de Braga
Braga, Portugal
APDP - Associação Protectora dos Diabéticos de Portugal
Lisbon, Portugal
Hosp. das Forças Armadas_ Endocrinologia
Lisbon, Portugal
ULS De São João, E.P.E. - Hospital de São João
Porto, Portugal
ULS De Matosinhos E.P.E.- Hospital Pedro Hispano
Senhora Da Hora, Matosinhos, Portugal
Hospital da Luz Arrabida, S.A.
Vila Nova de Gaia, Portugal
Institutul National De Diabet Nutritie Si Boli Metabolice Prof.Dr.N.Paulescu Bucuresti- Ion Movila
Bucharest, București, Romania
Poli Cardinal Med Srl
Reghin, Mureș County, Romania
CMI Dr. Pletea Noemi SRL
Bacau, Romania
SC Nutrilife SRL
Bucharest, Romania
Diabet Med SRL
Bucharest, Romania
Medical Practice SRL
Oradea, Romania
Spital Judetean De Urgenta Satu Mare
Satu Mare, Romania
Cabinet Medical Dr Geru SRL
Timișoara, Romania
King Chulalongkorn Memorial Hospital_Endocrinology
Bangkok, Thailand
Rajavithi Hospital_Diabetes and Endocrinology
Bangkok, Thailand
Ramathibodi Hospital
Bangkok, Thailand
Siriraj Hospital
Bangkok, Thailand
Srinagarind Hospital
Khon Kaen, Thailand
Başkent Üniversitesi Adana-Endokrinoloji
Adana /yüreği̇r, Turkey (Türkiye)
Ankara Bilkent Şehir Hastanesi-Dahiliye
Ankara, Turkey (Türkiye)
İnönü Üniversitesi Turgut Özal Tıp Merkezi Hastanesi- Endokrinoloji
Battalgazi / Malatya, Turkey (Türkiye)
Göztepe Prof. Dr.Süleyman Yalçın Şehir Hastanesi- Dahiliye
Istanbul, Turkey (Türkiye)
Marmara Üniversitesi Pendik EAH- Endokrinoloji
Pendik/istanbul, Turkey (Türkiye)
Sivas Cumhuriyet Üniversitesi Hastanesi -Endokrinoloji
Sivas, Turkey (Türkiye)
Adana Şehir Eğitim ve Araştırma Hastanesi-Endokrinoloji
Yüreğir/Adana, Turkey (Türkiye)