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NOT YET RECRUITING
NCT07400107
PHASE3

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

View on ClinicalTrials.gov

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

DRUG

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.

DRUG

Semaglutide

Semaglutide will be administered subcutaneously using PDS290 pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.

DRUG

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.

DRUG

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)