Clinical trial

AMAZE 2: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Type 2 Diabetes Lose Weight

Recruiting now · Phase 3 · 7 countries · Registry ID NCT07533175

Recruiting nowPhase 3Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed
SexAll
Healthy volunteersNot accepted
ConditionDiabetes Mellitus, Overweight, Obesity

Full registry 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.

Treatments and study arms

NNC0487-0111

Drug

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)

Drug

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.

Primary outcomes

Relative change in body weightFrom baseline (week 0) to (week 84)

Measured as percentage (%) of body weight.

Study locations

74 locations were listed when this page was built. The first 40 are shown.

Kynet Recoleta🇦🇷 Buenos Aires, Argentina
Centro médico privado Cemaic🇦🇷 Córdoba, Argentina
MICA- Medicina e Investigación Cardiometabólica🇦🇷 Manuel Alberti, Buenos Aires, Argentina
CEDIR - Centro de diagnóstico y rehabilitación Santa Fe🇦🇷 Santa Fe, Argentina
PUCCAMP - Hospital e Maternidade Celso Pierro🇧🇷 Campinas, São Paulo, Brazil
Cline Research Center🇧🇷 Curitiba, Paraná, Brazil
CPCLIN - Centro de Pesquisas Clínicas🇧🇷 São Paulo, São Paulo, Brazil
Centro de Pesquisa Clínica do Hospital das Clínicas da Faculdade de Medicina da USP🇧🇷 São Paulo, São Paulo, Brazil
Opca bolnica Karlovac🌐 Karlovac, Croatia
Specijalna Bolnica za medicinsku rehabilitaciju Krapinske Toplice_Endocrinology🌐 Krapinske Toplice, Croatia
Specijalna bolnica Thalassotherapia🌐 Opatija, Croatia
Poliklinika SLAVONIJA OSIJEK🌐 Osijek, Croatia
Opca bolnica Pula🌐 Pula, Croatia
Poliklinika za oftalmologiju optometriju i neurologiju Lux🌐 Solin, Croatia
Opca bolnica Varazdin_Endocrinology🌐 Varaždin, Croatia
Poliklinika Solmed🌐 Zagreb, Croatia
DRC Kft.🇭🇺 Balatonfüred, Hungary
PVN Kutató Kft.🇭🇺 Budapest, Hungary
Semmelweis Egyetem🇭🇺 Budapest, Hungary
Szent Margit Rendelőintézet Nonprofit Kft.🇭🇺 Budapest, Hungary
Trantor 99 Bt🇭🇺 Budapest, Hungary
Észak-Pesti Centrumkórház Honvédkórház - Diabetológia Szakrendelés🇭🇺 Budapest, Hungary
Somogy Vármegyei Kaposi Mór Oktató Kórház🇭🇺 Kaposvár, Hungary
Szegedi Tudomanyegyetem St Györgyi Albert Klinikai Központ🇭🇺 Szeged, Csongrád-Csanád, Hungary
Dip. Med. Chir. delle malattie digestive, epatiche ed endo-meta - UOC Endocrinologia e prevenzione e cura del diabete🇮🇹 Bologna, Emilia-Romagna, Italy
Grande Ospedale Metropolitano Niguarda - Dipartimento Medico Polispecialistico - Diabetologia🇮🇹 Milan, Lombardy, Italy
IRCCS Ospedale San Raffaele Milano🇮🇹 Milan, Italy
A.O.U Policlinico Paolo Giaccone - U.O.C Medicina Interna🇮🇹 Palermo, Sicily, Italy
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone - PSD Nutrizione Clinica, Obesità e Metabolismo🇮🇹 Palermo, Sicily, Italy
Universita Degli Studi Di Roma La Sapienza - Policlinico Umberto I Medicina Sperimentale🇮🇹 Rome, Lazio, Italy
Clinstile S.A. de C.V.🇲🇽 Col Roma Norte, Mexico City, Mexico
Instituto Nacional de Nutricion - Unidad de Inv de Enf Metab🇲🇽 Distrito Federal, México, D.F., Mexico
Centro de Investigacion Clinica Endocrinologica de Jalisco🇲🇽 Guadalajara, Jalisco, Mexico
Centro de Investigación Clinica de Oaxaca (CICLO)🇲🇽 Oaxaca City, Oaxaca, Mexico
Consultorio de Endocrinología y Pediatría🇲🇽 Puebla City, Mexico
Unidad Medica para la Salud Integral (UMSI)🇲🇽 San Nicolás de los Garza, Nuevo León, Mexico
CMI Dr. Pletea Noemi SRL🇷🇴 Bacau, Romania
Diabet Med SRL🇷🇴 Bucharest, Romania
SC Clinica Diabnutrimed S.R.L.🇷🇴 Bucharest, Romania
SC Nutrilife SRL🇷🇴 Bucharest, Romania