Efficacy and Safety of NNC0487-0111 s.c. Once-weekly in Participants With Overweight or Obesity, and Type 2 Diabetes (AMAZE 2)
Status: Recruiting
Location: See all (74) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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. There are 2 study treatments in this study taken as injections under the skin once a week. Participants will either get NNC0487-0111 (the treatment being tested) or Placebo (treatment that has no active medicine in it). Which treatment participants get is decided by chance.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Male or female (sex at birth).
• Age 18 years or above at the time of signing informed consent.
• Diagnosed with type 2 diabetes mellitus more than equal to (≥) 180 days before 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.
• Haemoglobin A1c (HbA1c) 7-10% \[53-86 (millimoles per mole) mmol/mol\] (both inclusive) as measured by the central laboratory at screening.
Locations
United States
Alabama
Univ of Alabama Birmingham
RECRUITING
Birmingham
California
Headlands Research California, LLC
RECRUITING
Escondido
Torrance Clinical Research Institute, Inc.
RECRUITING
Lomita
Diablo Clinical Research, Inc.
RECRUITING
Walnut Creek
Florida
Northeast Research Institute
RECRUITING
Fleming Island
Jacksonville Ctr Clin Res
RECRUITING
Jacksonville
Florida Institute for Clinical Research, LLC
RECRUITING
Orlando
Oviedo Medical Research, LLC
RECRUITING
Oviedo
Minnesota
International Diabetes Center
RECRUITING
Minneapolis
New York
Southgate Medical Group, LLP
RECRUITING
West Seneca
South Carolina
Spartanburg Medical Research
RECRUITING
Spartanburg
Tennessee
M3 Wake Research Chattanooga
RECRUITING
Chattanooga
Texas
UT Southwestern Medical Center - Lingvay
RECRUITING
Dallas
PlanIt Research, PLLC
RECRUITING
Houston
Virginia
National Clin Res Inc.
RECRUITING
Richmond
Other Locations
Argentina
Kynet Recoleta
RECRUITING
Buenos Aires
Centro médico privado Cemaic
RECRUITING
Córdoba
MICA- Medicina e Investigación Cardiometabólica
NOT_YET_RECRUITING
Manuel Alberti
CEDIR - Centro de diagnóstico y rehabilitación Santa Fe
RECRUITING
Santa Fe
Brazil
PUCCAMP - Hospital e Maternidade Celso Pierro
RECRUITING
Campinas
Cline Research Center
RECRUITING
Curitiba
Centro de Pesquisa Clínica do Hospital das Clínicas da Faculdade de Medicina da USP
NOT_YET_RECRUITING
São Paulo
CPCLIN - Centro de Pesquisas Clínicas
RECRUITING
São Paulo
Croatia
Opca bolnica Karlovac
RECRUITING
Karlovac
Specijalna Bolnica za medicinsku rehabilitaciju Krapinske Toplice_Endocrinology
RECRUITING
Krapinske Toplice
Specijalna bolnica Thalassotherapia
RECRUITING
Opatija
Poliklinika SLAVONIJA OSIJEK
RECRUITING
Osijek
Opca bolnica Pula
RECRUITING
Pula
Poliklinika za oftalmologiju optometriju i neurologiju Lux
RECRUITING
Solin
Opca bolnica Varazdin_Endocrinology
RECRUITING
Varaždin
Poliklinika Solmed
RECRUITING
Zagreb
Hungary
DRC Kft.
NOT_YET_RECRUITING
Balatonfüred
Észak-Pesti Centrumkórház Honvédkórház - Diabetológia Szakrendelés
NOT_YET_RECRUITING
Budapest
PVN Kutató Kft.
NOT_YET_RECRUITING
Budapest
Semmelweis Egyetem
COMPLETED
Budapest
Szent Margit Rendelőintézet Nonprofit Kft.
NOT_YET_RECRUITING
Budapest
Trantor 99 Bt
NOT_YET_RECRUITING
Budapest
Somogy Vármegyei Kaposi Mór Oktató Kórház
NOT_YET_RECRUITING
Kaposvár
Szegedi Tudomanyegyetem St Györgyi Albert Klinikai Központ
NOT_YET_RECRUITING
Szeged
Italy
Dip. Med. Chir. delle malattie digestive, epatiche ed endo-meta - UOC Endocrinologia e prevenzione e cura del diabete
NOT_YET_RECRUITING
Bologna
Grande Ospedale Metropolitano Niguarda - Dipartimento Medico Polispecialistico - Diabetologia
NOT_YET_RECRUITING
Milan
IRCCS Ospedale San Raffaele Milano
NOT_YET_RECRUITING
Milan
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone - PSD Nutrizione Clinica, Obesità e Metabolismo
NOT_YET_RECRUITING
Palermo
Dip. di Medicina Interna Policlinico Universitario Palermo
NOT_YET_RECRUITING
Palermo
Universita Degli Studi Di Roma La Sapienza - Policlinico Umberto I Medicina Sperimentale
NOT_YET_RECRUITING
Rome
Mexico
Clinstile S.A. de C.V.
NOT_YET_RECRUITING
Col Roma Norte
Instituto Nacional de Nutricion - Unidad de Inv de Enf Metab
NOT_YET_RECRUITING
Distrito Federal
Centro de Investigacion Clinica Endocrinologica de Jalisco
NOT_YET_RECRUITING
Guadalajara
Centro de Investigación Clinica de Oaxaca (CICLO)
NOT_YET_RECRUITING
Oaxaca City
Consultorio de Endocrinología y Pediatría
NOT_YET_RECRUITING
Puebla City
Unidad Medica para la Salud Integral (UMSI)
NOT_YET_RECRUITING
San Nicolás De Los Garza
Republic of Korea
Chonnam National University Hospital_Endocrinology
RECRUITING
Gwangju
Asan Medical Center_Endocrinology
RECRUITING
Seoul
Kyunghee University Medical Center_Endocrinology
RECRUITING
Seoul
Seoul National University Hospital_Endocrinology
RECRUITING
Seoul
Severance Hospital, Yonsei University Health System_Endocrinology
RECRUITING
Seoul
The Catholic University of Korea, Yeouido ST. Mary's Hospital_Endocrinology
RECRUITING
Seoul
Seoul National University Bundang Hospital_Endocrinology
RECRUITING
Seoungnam-si
Romania
CMI Dr. Pletea Noemi SRL
RECRUITING
Bacau
Diabet Med SRL
RECRUITING
Bucharest
SC Clinica Diabnutrimed S.R.L.
RECRUITING
Bucharest
SC Nutrilife SRL
RECRUITING
Bucharest
Cmi Dr. Cojocaru Cristina
RECRUITING
Constanța
A&C Medical Prime S.R.L.
NOT_YET_RECRUITING
Craiova
S.C. Top Diabet Srl
RECRUITING
Craiova
Poli Cardinal Med Srl
RECRUITING
Reghin
Spital Judetean De Urgenta Satu Mare
RECRUITING
Satu Mare
Slovakia
DIA - KONTROL s.r.o.
RECRUITING
Levice
Narodny Endokrinologicky a diabetologicky ustav
RECRUITING
Ľubochňa
OLIVER - MED s.r.o.
RECRUITING
Rimavská Sobota
Peter Farkas MD, s.r.o.
RECRUITING
Šahy
DEImedi, s. r. o.
RECRUITING
Šurany
ARETEUS s.r.o.
RECRUITING
Trebišov
ARETEUS s.r.o.
NOT_YET_RECRUITING
Trebišov
Contact Information
Primary
Novo Nordisk
clinicaltrials@novonordisk.com
(+1) 866-867-7178
Time Frame
Start Date: 2026-04-13
Estimated Completion Date: 2028-08-07
Participants
Target number of participants: 630
Treatments
Experimental: NNC0487-0111 dose level 1
Participants will be randomized to receive NNC0487-0111 dose level 1 subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.
Experimental: NNC0487-0111 dose level 2
Participants will be randomized to receive NNC0487-0111 dose level 2 subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.
Experimental: NNC0487-0111 dose level 3
Participants will be randomized to receive NNC0487-0111 dose level 3 subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.
Experimental: NNC0487-0111 dose level 4
Participants will be randomized to receive NNC0487-0111 dose level 4 subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.
Placebo_comparator: Placebo
Participants will receive placebo matched to NNC0487-0111 subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.
Related Therapeutic Areas
Sponsors
Leads: Novo Nordisk A/S