RecruitingRecruiting
AMAZE 2: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Type 2 Diabetes Lose Weight
NCT07533175 · Novo Nordisk A/S
In plain English
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Official title
Efficacy and Safety of NNC0487-0111 s.c. Once-weekly in Participants With Overweight or Obesity, and Type 2 Diabetes (AMAZE 2)
About this study
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 criteria
Inclusion Criteria:
* 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.
Exclusion Criteria:
* Renal impairment with estimated Glomerular Filtration Rate (eGFR) less than (\<) 30 milliliter per minute per meter square (mL/min/1.73 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) before screening or are expected to require treatment 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 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 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.
Study design
Enrollment target: 630 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2026-04-13
Estimated completion: 2028-08-07
Last updated: 2026-06-02
Interventions
Drug: NNC0487-0111Drug: Placebo (matched to NNC0487-0111)
Primary outcomes
- • Relative change in body weight (From baseline (week 0) to (week 84))
Sponsor
Novo Nordisk A/S · industry
Contacts & investigators
ContactNovo Nordisk · contact · clinicaltrials@novonordisk.com · (+1) 866-867-7178
InvestigatorClinical Transparency (dept. 2834) · study_director, Novo Nordisk A/S
All locations (74)
Univ of Alabama BirminghamRecruiting
Birmingham, Alabama, United States
Headlands Research California, LLCRecruiting
Escondido, California, United States
Torrance Clinical Research Institute, Inc.Recruiting
Lomita, California, United States
Diablo Clinical Research, Inc.Recruiting
Walnut Creek, California, United States
Northeast Research InstituteRecruiting
Fleming Island, Florida, United States
Jacksonville Ctr Clin ResRecruiting
Jacksonville, Florida, United States
Florida Institute for Clinical Research, LLCRecruiting
Orlando, Florida, United States
Oviedo Medical Research, LLCRecruiting
Oviedo, Florida, United States
International Diabetes CenterRecruiting
Minneapolis, Minnesota, United States
Southgate Medical Group, LLPRecruiting
West Seneca, New York, United States
Spartanburg Medical ResearchRecruiting
Spartanburg, South Carolina, United States
M3 Wake Research ChattanoogaRecruiting
Chattanooga, Tennessee, United States
UT Southwestern Medical Center - LingvayRecruiting
Dallas, Texas, United States
PlanIt Research, PLLCRecruiting
Houston, Texas, United States
National Clin Res Inc.Recruiting
Richmond, Virginia, United States
MICA- Medicina e Investigación CardiometabólicaNot Yet Recruiting
Manuel Alberti, Buenos Aires, Argentina
Kynet RecoletaRecruiting
Buenos Aires, Argentina
Centro médico privado CemaicRecruiting
Córdoba, Argentina
CEDIR - Centro de diagnóstico y rehabilitación Santa FeRecruiting
Santa Fe, Argentina
Cline Research CenterRecruiting
Curitiba, Paraná, Brazil
PUCCAMP - Hospital e Maternidade Celso PierroRecruiting
Campinas, São Paulo, Brazil
CPCLIN - Centro de Pesquisas ClínicasRecruiting
São Paulo, São Paulo, Brazil
Centro de Pesquisa Clínica do Hospital das Clínicas da Faculdade de Medicina da USPNot Yet Recruiting
São Paulo, São Paulo, Brazil
Opca bolnica KarlovacRecruiting
Karlovac, Croatia
Specijalna Bolnica za medicinsku rehabilitaciju Krapinske Toplice_EndocrinologyRecruiting
Krapinske Toplice, Croatia
Specijalna bolnica ThalassotherapiaRecruiting
Opatija, Croatia
Poliklinika SLAVONIJA OSIJEKRecruiting
Osijek, Croatia
Opca bolnica PulaRecruiting
Pula, Croatia
Poliklinika za oftalmologiju optometriju i neurologiju LuxRecruiting
Solin, Croatia
Opca bolnica Varazdin_EndocrinologyRecruiting
Varaždin, Croatia
Poliklinika SolmedRecruiting
Zagreb, Croatia
Szegedi Tudomanyegyetem St Györgyi Albert Klinikai KözpontNot Yet Recruiting
Szeged, Csongrád-Csanád, Hungary
DRC Kft.Not Yet Recruiting
Balatonfüred, Hungary
Szent Margit Rendelőintézet Nonprofit Kft.Not Yet Recruiting
Budapest, Hungary
Semmelweis EgyetemCompleted
Budapest, Hungary
PVN Kutató Kft.Not Yet Recruiting
Budapest, Hungary
Észak-Pesti Centrumkórház Honvédkórház - Diabetológia SzakrendelésNot Yet Recruiting
Budapest, Hungary
Trantor 99 BtNot Yet Recruiting
Budapest, Hungary
Somogy Vármegyei Kaposi Mór Oktató KórházNot Yet Recruiting
Kaposvár, Hungary
Dip. Med. Chir. delle malattie digestive, epatiche ed endo-meta - UOC Endocrinologia e prevenzione e cura del diabeteNot Yet Recruiting
Bologna, Emilia-Romagna, Italy
Universita Degli Studi Di Roma La Sapienza - Policlinico Umberto I Medicina SperimentaleNot Yet Recruiting
Rome, Lazio, Italy
Grande Ospedale Metropolitano Niguarda - Dipartimento Medico Polispecialistico - DiabetologiaNot Yet Recruiting
Milan, Lombardy, Italy
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone - PSD Nutrizione Clinica, Obesità e MetabolismoNot Yet Recruiting
Palermo, Sicily, Italy
IRCCS Ospedale San Raffaele MilanoNot Yet Recruiting
Milan, Italy
Dip. di Medicina Interna Policlinico Universitario PalermoNot Yet Recruiting
Palermo, Italy
Centro de Investigacion Clinica Endocrinologica de JaliscoNot Yet Recruiting
Guadalajara, Jalisco, Mexico
Clinstile S.A. de C.V.Not Yet Recruiting
Col Roma Norte, Mexico City, Mexico
Instituto Nacional de Nutricion - Unidad de Inv de Enf MetabNot Yet Recruiting
Distrito Federal, México, D.F., Mexico
Unidad Medica para la Salud Integral (UMSI)Not Yet Recruiting
San Nicolás de los Garza, Nuevo León, Mexico
Centro de Investigación Clinica de Oaxaca (CICLO)Not Yet Recruiting
Oaxaca City, Oaxaca, Mexico
Consultorio de Endocrinología y PediatríaNot Yet Recruiting
Puebla City, Mexico
S.C. Top Diabet SrlRecruiting
Craiova, Dolj, Romania
Poli Cardinal Med SrlRecruiting
Reghin, Mureș County, Romania
CMI Dr. Pletea Noemi SRLRecruiting
Bacau, Romania
SC Nutrilife SRLRecruiting
Bucharest, Romania
SC Clinica Diabnutrimed S.R.L.Recruiting
Bucharest, Romania
Diabet Med SRLRecruiting
Bucharest, Romania
Cmi Dr. Cojocaru CristinaRecruiting
Constanța, Romania
A&C Medical Prime S.R.L.Not Yet Recruiting
Craiova, Romania
Spital Judetean De Urgenta Satu MareRecruiting
Satu Mare, Romania
DIA - KONTROL s.r.o.Recruiting
Levice, Slovakia
Narodny Endokrinologicky a diabetologicky ustavRecruiting
Ľubochňa, Slovakia
OLIVER - MED s.r.o.Recruiting
Rimavská Sobota, Slovakia
Peter Farkas MD, s.r.o.Recruiting
Šahy, Slovakia
DEImedi, s. r. o.Recruiting
Šurany, Slovakia
ARETEUS s.r.o.Recruiting
Trebišov, Slovakia
ARETEUS s.r.o.Not Yet Recruiting
Trebišov, Slovakia
Seoul National University Bundang Hospital_EndocrinologyRecruiting
Seoungnam-si, Gyeonggi-do, South Korea
Chonnam National University Hospital_EndocrinologyRecruiting
Gwangju, South Korea
Kyunghee University Medical Center_EndocrinologyRecruiting
Seoul, South Korea
Seoul National University Hospital_EndocrinologyRecruiting
Seoul, South Korea
Severance Hospital, Yonsei University Health System_EndocrinologyRecruiting
Seoul, South Korea
Asan Medical Center_EndocrinologyRecruiting
Seoul, South Korea
The Catholic University of Korea, Yeouido ST. Mary's Hospital_EndocrinologyRecruiting
Seoul, South Korea