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Clinical Trials in the USA / NCT07533175
Recruiting Phase 3

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 · tracked via the Priya Life Science USA tracker
Sponsor
Novo Nordisk A/S
Phase
Phase 3
Started
2026-04-13
Last updated
2026-09-04

Condition(s) studied

Diabetes MellitusOverweightObesity

Investigational drug(s) / intervention(s)

NNC0487-0111Placebo (matched to NNC0487-0111)

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.

Placebo (matched to NNC0487-0111): Placebo matched to NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (74)

FacilityCityRegionStatus
Univ of Alabama Birmingham Birmingham Alabama Recruiting
Headlands Research California, LLC Escondido California Completed
Torrance Clinical Research Institute, Inc. Lomita California Recruiting
Diablo Clinical Research, Inc. Walnut Creek California Recruiting
Northeast Research Institute Fleming Island Florida Recruiting
Jacksonville Ctr Clin Res Jacksonville Florida Recruiting
Florida Institute for Clinical Research, LLC Orlando Florida Recruiting
Oviedo Medical Research, LLC Oviedo Florida Recruiting
International Diabetes Center Minneapolis Minnesota Recruiting
Southgate Medical Group, LLP West Seneca New York Recruiting
Spartanburg Medical Research Spartanburg South Carolina Recruiting
M3 Wake Research Chattanooga Chattanooga Tennessee Recruiting
UT Southwestern Med Center Dallas Texas Recruiting
PlanIt Research, PLLC Houston Texas Recruiting
National Clin Res Inc. Richmond Virginia Recruiting
MICA- Medicina e Investigación Cardiometabólica Manuel Alberti Buenos Aires Recruiting
Kynet Recoleta Buenos Aires Argentina Recruiting
Centro médico privado Cemaic Córdoba Argentina Recruiting
CEDIR - Centro de diagnóstico y rehabilitación Santa Fe Santa Fe Argentina Recruiting
Cline Research Center Curitiba Paraná Recruiting
PUCCAMP - Hospital e Maternidade Celso Pierro Campinas São Paulo Recruiting
CPCLIN - Centro de Pesquisas Clínicas São Paulo São Paulo Recruiting
Centro de Pesquisa Clínica do Hospital das Clínicas da Faculdade de Medicina da USP São Paulo São Paulo Recruiting
Opca bolnica Karlovac Karlovac Croatia Recruiting
Specijalna Bolnica za medicinsku rehabilitaciju Krapinske Toplice_Endocrinology Krapinske Toplice Croatia Recruiting
Specijalna bolnica Thalassotherapia Opatija Croatia Recruiting
Poliklinika SLAVONIJA OSIJEK Osijek Croatia Recruiting
Opca bolnica Pula Pula Croatia Recruiting
Poliklinika za oftalmologiju optometriju i neurologiju Lux Solin Croatia Recruiting
Opca bolnica Varazdin_Endocrinology Varaždin Croatia Recruiting
Poliklinika Solmed Zagreb Croatia Recruiting
Szegedi Tudomanyegyetem St Györgyi Albert Klinikai Központ Szeged Csongrád-Csanád Not Yet Recruiting
DRC Kft. Balatonfüred Hungary Not Yet Recruiting
Szent Margit Rendelőintézet Nonprofit Kft. Budapest Hungary Not Yet Recruiting
Semmelweis Egyetem Budapest Hungary Completed
PVN Kutató Kft. Budapest Hungary Not Yet Recruiting
Észak-Pesti Centrumkórház Honvédkórház - Diabetológia Szakrendelés Budapest Hungary Not Yet Recruiting
Trantor 99 Bt Budapest Hungary Not Yet Recruiting
Somogy Vármegyei Kaposi Mór Oktató Kórház Kaposvár Hungary Not Yet Recruiting
Dip. Med. Chir. delle malattie digestive, epatiche ed endo-meta - UOC Endocrinologia e prevenzione e cura del diabete Bologna Emilia-Romagna Recruiting

+ 34 more sites — see the full list on the official registry below.

More Novo Nordisk A/S trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07533175 on ClinicalTrials.gov ↗ ← All trials in the USA