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
AMAZE 8
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)
3 other identifiers
interventional
1,000
14 countries
120
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 obesity
Started May 2026
Typical duration for phase_3 obesity
120 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 3, 2026
CompletedFirst Posted
Study publicly available on registry
February 10, 2026
CompletedStudy Start
First participant enrolled
May 20, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 12, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 26, 2029
March 12, 2026
March 1, 2026
2.6 years
February 3, 2026
March 11, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Relative change in body weight
Measured as percentage of body weight.
From baseline (week 0) to week 84
Secondary Outcomes (24)
Change in waist circumference
From baseline (week 0) to week 84
Change in systolic blood pressure (SBP)
From baseline (week 0) to week 84
Change in body weight
From baseline (week 0) to week 84 and week 104
Change in body mass index (BMI)
From baseline (week 0) to week 84 and week 104
Number of participants with achievement of in haemoglobin A1c (HbA1c) < 7.0 percent (%) (yes/no)
From baseline (week 0) to week 84
- +19 more secondary outcomes
Study Arms (2)
NNC0487-0111
EXPERIMENTALParticipants will receive NNC0487-0111 and placebo matched to semaglutide subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.
Semaglutide
ACTIVE COMPARATORParticipants will receive semaglutide and placebo matched to NNC0487-0111 subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.
Interventions
NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.
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 will be administered subcutaneously using pre- filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.
Placebo matched to semaglutide will be administered subcutaneously using pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.
Eligibility Criteria
You may qualify if:
- Male or female (sex at birth).
- Age 18 years or above at the time of signing informed consent.
- Diagnosed with type 2 diabetes mellitus ≥ 180 days before screening.
- Haemoglobin A1c (HbA1c) 7-10 percentage (%) (53-86 millimole per mole \[mmol/mol\]) (both inclusive) as measured by the central laboratory at screening.
- Treatment with lifestyle intervention, and/or 0-3 marketed oral antidiabetic drugs (OAD)s (metformin, α-glucosidase inhibitors (AGI), glinides, sodium-glucose cotransporter 2 inhibitor (SGLT2i), thiazolidinediones, or sulfonylureas (SU) as a single agent or in combination) according to local label. Treatment with oral antidiabetic drugs should be stable (same drug(s), dose and dosing frequency) before screening.
You may not qualify if:
- Renal impairment with estimated Glomerular Filtration Rate (eGFR) \< 30 milliliter (mL)/ minute (min)/1.73 meter squared (m\^2) (2021 Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\] formula), at 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 within 90 days before screening or in the period between screening and randomization. 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 8.
- Recurrent severe hypoglycaemic episodes within the last year as judged by the investigator.
- Treatment with glucagon-like peptide-1 (GLP-1) receptor agonists (RA), dual GLP-1/gastric inhibitory peptide (GIP) RAs (or any other GLP-1 based treatment), or amylin analogues before screening.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (120)
Encore Medical Research LLC
Hollywood, Florida, 33024, United States
Optimal Research Sites
Orange City, Florida, 32763, United States
Encore Medical Research of Weston
Weston, Florida, 33331, United States
Endocrine Research Solutions, Inc
Roswell, Georgia, 30076, United States
Elite Clinical Trials
Blackfoot, Idaho, 83221, United States
Endo And Metab Cons
Rockville, Maryland, 20852, United States
Arcturus Healthcare, PLC.
Troy, Michigan, 48098-6368, United States
Velocity Clin Res, Dallas
Dallas, Texas, 75230, United States
Consano Clinical Research, LLC
Shavano Park, Texas, 78231, United States
Selma Medical Associates
Winchester, Virginia, 22601-3834, United States
Centro de Investigaciones Metabólicas
Capital Federal, Buenos Aires, C1056ABI, Argentina
Centro Médico CIMEL
Lanús Este, Buenos Aires, B1824KAJ, Argentina
Centro Médico Privado San Vicente Diabetes
Córdoba, X5006IKK, Argentina
Núcleo de Pesquisa Clínica do Rio Grande do Sul Ltda.
Porto Alegre, Rio Grande do Sul, 90430-001, Brazil
i9 Pesquisas Clínicas
Campinas, São Paulo, 13092-133, Brazil
CPQuali Pesquisa Clínica Ltda
São Paulo, São Paulo, 01228-000, Brazil
BR Trials - Ensaios Clínicos e Consultoria Ltda.
São Paulo, São Paulo, 01236-030, Brazil
Dr. Tatyana Metalova - AIPSMCE EOOD
Gotse Delchev, 2900, Bulgaria
Medical centre Zdrave 1 OOD
Kozloduy, 3320, Bulgaria
UMHAT Pulmed OOD - Pazardzhik, Department of Internal Diseases
Pazardzhik, 4400, Bulgaria
MHAT Heart and Brain EAD - Pleven, Endocrinology and Metabolic Diseases
Pleven, 5800, Bulgaria
DCC I- Pleven EOOD Endocrinology
Pleven, 5801, Bulgaria
MHAT Knyaginya Klementina - Sofia EAD
Sofia, 1233, Bulgaria
MHAT Sveta Sofia EOOD, Department of Endocrinology and Metabolic diseases
Sofia, 1404, Bulgaria
Acibadem City Clinic UMHAT Tokuda EAD, Endocrinology
Sofia, 1407, Bulgaria
USHATE Akad. Ivan Penchev EAD, Second Clinic of Endocrinology
Sofia, 1431, Bulgaria
Medical Institute of Ministry of interior
Sofia, 1606, Bulgaria
Medical Centre - Clinic Nova EOOD
Varna, 9000, Bulgaria
Poliklinika Medikol Zagreb
Grad Zagreb, 10000, Croatia
Opca bolnica Karlovac
Karlovac, 47000, Croatia
Specijalna Bolnica za medicinsku rehabilitaciju Krapinske Toplice_Endocrinology
Krapinske Toplice, 49217, Croatia
Poliklinika SLAVONIJA OSIJEK
Osijek, 31000, Croatia
Clinical Hospital Centre Rijeka_Endocrinology
Rijeka, 51 000, Croatia
General Hospital Dr. Josip Bencevic_Diabetic department
Slavonski Brod, 35 000, Croatia
Opca bolnica Varazdin_Endocrinology
Varaždin, 42 000, Croatia
Poliklinika Solmed
Zagreb, 10000, Croatia
Herz- und Diabeteszentrum NRW - Bad Oeynhausen
Bad Oeynhausen, 32545, Germany
Zentrum fuer klinische Studien Suedbrandenburg GmbH
Elsterwerda, 04910, Germany
Praxis am Markt Dr. Becker
Essen, 45355, Germany
MVZ im Altstadt-Carree Fulda GmbH - Zentrum für klinische Studien
Fulda, 36037, Germany
Diabetes-Zentrum-Wilhelmsburg GbR
Hamburg, 21109, Germany
Diabetologische Gemeinschaftspraxis Dr. Staudenmeyer und Dr. Schiwietz
Lingen, 49808, Germany
SMO.MD GmbH - Zentrum für klinische Studien
Magdeburg, 39120, Germany
Institut für Diabetesforschung Osnabrück
Osnabrück, 49080, Germany
ceda - Centrum für Diabetologie und Allgemeinmedizin Pohlheim
Pohlheim, 35415, Germany
Forschungszentrum Ruhr KliFoCenter GmbH, Kahrmann
Witten, 58455, Germany
Debreceni Egyetem
Debrecen, Hajdú-Bihar, 4032, Hungary
Komáromi Selye János Kórház
Komárom, Komárom-Esztergom, 2900, Hungary
Óbudai Egészségügyi Centrum
Budapest, Pest County, 1036, Hungary
Borbánya Praxis E.Ü. Kft.
Nyíregyháza, Szabolcs-Szatmar Varmegye, 4405, Hungary
Békés Vármegyei Központi Kórház
Gyula, 5700, Hungary
Endolife Specialty Hospitals
Guntur, Andhra Pradesh, 522001, India
Nirmal Hospital Pvt. Ltd.
Surat, Gujarat, 395002, India
SSG Hospital, Baroda
Vadodara, Gujarat, 390001, India
Diacon Hospital Private Limited
Bangalore, Karnataka, 560010, India
Lifecare Hospital and Research Centre
Bengaluru, Karnataka, 560066, India
Amrita Institute Of Medical Sciences & Research Centre
Kochi, Kerala, 682041, India
TOTALL Diabetes Hormone Institute
Indore, Madhya Pradesh, 452010, India
BSES MG hospital
Mumbai, Maharashtra, 400058, India
Shalini Tai Meghe Hospital and Research Center
Nagpur, Maharashtra, 441110, India
Chellaram Diabetes Institute
Pune, Maharashtra, 411021, India
SMS Medical College & Hospital
Jaipur, Rajasthan, 302004, India
Diabetes, Thyroid and Endocrine Centre
Jaipur, Rajasthan, 302006, India
Arthur Asirvatham hospital,
Madurai, Tamil Nadu, 625 020, India
NIZAM'S Institute of Medical Sciences
Hyderabad, Telangana, 500082, India
IPGME&R and SSKM Hospital
Kolkata, West Bengal, 700020, India
Rajiv Gandhi Centre for Diabetes and Endocrinology, J.N Medical College, Aligarh Muslim University
Aligarh, 202002, India
All India Institute of Medical Sciences (AIIMS)
New Delhi, 110029, India
Jothydev's Diabetes & Research Center
Thriruvananthapuram, 695 032, India
Diseño y Planeación en Investigación Médica S.C.
Guadalajara, Jalisco, 44600, Mexico
Alliance CEINV Salud S.A. de C.V.
Monterrey, Nuevo León, 64020, Mexico
Centro de Estudios de Investigación Metabólicos y Cardio
Ciudad Madero, Tamaulipas, 89440, Mexico
Gabinety Medyczne MATUSZEK Beata Matyjaszek-Matuszek Prywatna Praktyka Specjalistyczna
Lublin, Lesser Poland Voivodeship, 20-064, Poland
EKAMED sp. z o.o.
Lublin, Lublin Voivodeship, 20-718, Poland
Przychodnie Grudziadz Sp. z o. o.
Grudziądz, Mazovian Voivodeship, 86-300, Poland
Legeartis Poradnie Specjalistyczne Sp. z o.o.
Bialystok, Podlaskie Voivodeship, 15-404, Poland
NZOZ Specjalistyczny Osrodek Internistyczno-Diabetologiczny Małgorzata Arciszewska
Bialystok, 15-435, Poland
NZOZ Vita-Diabetica Malgorzata Buraczyk
Bialystok, 15-879, Poland
Centrum Kliniczno-Badawcze J.Brzezicki B.Gornikiewicz-Brzezicka Lekarze sp.p.
Elblag, 82-300, Poland
Specjalistyczny Gabinet Diabetologiczny Radoslaw Rumianowski
Gorzów Wielkopolski, 66-400, Poland
SP ZOZ w Kalwarii Zebrzydowskiej
Kalwaria Zebrzydowska, 34-130, Poland
Linden sp. z o.o. sp. k.
Krakow, 30-105, Poland
Diamond Clinic sp zoo
Krakow, 31-559, Poland
Beata Miklaszewicz & Dariusz Dabrowski "CARDIAMED" s.j.
Legnica, 59-220, Poland
Serce Sp. z o.o.
Leszno, 64-100, Poland
Gabinet Lekarski Malgorzata Saryusz-Wolska
Lodz, 90-132, Poland
Centrum Terapii Wspolczesnej - J.M. Jasnorzewska S.K.A.
Lodz, 90-338, Poland
Niepubliczny Zaklad Opieki Zdrowotnej Przychodnia Specjalistyczna A Wittek H Rudzki Sp. j.
Ruda Śląska, 41-709, Poland
Lukmed 2 Sp. z o.o.
Siedlce, 08-110, Poland
Szpital Czerniakowski Sp. z o.o.
Warsaw, 00-739, Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Szyszko
Zabrze, 41-800, Poland
Prywatna Praktyka Lekarska Anna Chudoba
Żyrardów, 96-300, Poland
Hospital de Cascais
Alcabideche, 2755-009, Portugal
ULS Almada-Seixal E.P.E. - Hospital Garcia de Orta
Almada, 2805-267, Portugal
ULS De Braga, E.P.E. - Hospital de Braga
Braga, 4710-243, Portugal
APDP - Associação Protectora dos Diabéticos de Portugal
Lisbon, 1250-189, Portugal
Hosp. das Forças Armadas_ Endocrinologia
Lisbon, 1649-020, Portugal
ULS De São João, E.P.E. - Hospital de São João
Porto, 4200-319, Portugal
ULS De Matosinhos E.P.E.- Hospital Pedro Hispano
Senhora Da Hora, Matosinhos, 4464-513, Portugal
Hospital da Luz Arrabida, S.A.
Vila Nova de Gaia, 4400-346, Portugal
Institutul National De Diabet Nutritie Si Boli Metabolice Prof.Dr.N.Paulescu Bucuresti- Ion Movila
Bucharest, București, 020475, Romania
Poli Cardinal Med Srl
Reghin, Mureș County, 545300, Romania
CMI Dr. Pletea Noemi SRL
Bacau, 600154, Romania
SC Nutrilife SRL
Bucharest, 013764, Romania
Diabet Med SRL
Bucharest, 050913, Romania
Medical Practice SRL
Oradea, 410001, Romania
Spital Judetean De Urgenta Satu Mare
Satu Mare, 440055, Romania
Cabinet Medical Dr Geru SRL
Timișoara, 300288, Romania
King Chulalongkorn Memorial Hospital_Endocrinology
Bangkok, 10330, Thailand
Rajavithi Hospital_Diabetes and Endocrinology
Bangkok, 10400, Thailand
Ramathibodi Hospital
Bangkok, 10400, Thailand
Siriraj Hospital
Bangkok, 10700, Thailand
Srinagarind Hospital
Khon Kaen, 40002, Thailand
Başkent Üniversitesi Adana-Endokrinoloji
Adana /yüreği̇r, 01240, Turkey (Türkiye)
Ankara Bilkent Şehir Hastanesi-Dahiliye
Ankara, 06800, Turkey (Türkiye)
İnönü Üniversitesi Turgut Özal Tıp Merkezi Hastanesi- Endokrinoloji
Battalgazi / Malatya, 44280, Turkey (Türkiye)
Göztepe Prof. Dr.Süleyman Yalçın Şehir Hastanesi- Dahiliye
Istanbul, 34722, Turkey (Türkiye)
Marmara Üniversitesi Pendik EAH- Endokrinoloji
Pendik/istanbul, 34899, Turkey (Türkiye)
Sivas Cumhuriyet Üniversitesi Hastanesi -Endokrinoloji
Sivas, 58140, Turkey (Türkiye)
Adana Şehir Eğitim ve Araştırma Hastanesi-Endokrinoloji
Yüreğir/Adana, 1370, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Transparency (dept. 2834)
Novo Nordisk A/S
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 3, 2026
First Posted
February 10, 2026
Study Start
May 20, 2026
Primary Completion (Estimated)
December 12, 2028
Study Completion (Estimated)
January 26, 2029
Last Updated
March 12, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com