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

630 patients around the world

Available in Argentina, United States, Mexico, Brazil

Novo Nordisk A/S

13Research sites

630Patients around the world

This study is for people with

Obesity

Diabetes

Diabetes mellitus type 2

From 18 Years

All Gender

: 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.

: 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.

Centro Médico Privado CEMAIC - Córdoba

Monseñor Pablo Cabrera 2941, Córdoba

Kynet Investigación Clínica

Av. Pueyrredón 2446 4to piso, C1119 ACU, Cdad. Autónoma de Buenos Aires, Argentina

Centro de Diagnóstico y Rehabilitación - CEDIR

SAN MARTIN 3169 – Santa Fe, Santa Fe. CP 3000

MICA Medicina e Investigación Cardiometabólica

Argentina

CPClin – Centro de Pesquisas Clinicas LTDA

Avenida Angélica, 2162 – Consolação – São Paulo, SP, CEP:01228-200

Cline Research Center

Praça São Paulo da Cruz, 50 - Cabral, Curitiba - PR, 80030-000

Hospital e Maternidade Celso Pierro

Campinas, 13590-900

Hospital das Clínicas da Faculdade de Medicina da São Paulo - USP

Rua Dr. Ovídio Pires de Campos 785 - Estado de São Paulo 05403-000

CICEJ Centro de Investigación Clínica Endocrinológica de Jalisco S.C.

C. Tarascos 3469-Int. 505-503 y, Monraz, 44670 Guadalajara, Jal., Mexico

Clinstile S.A de C.V.

Durango 325, Roma Norte, Ciudad de México

StudyAMAZE 2

SponsorNovo Nordisk A/S

Study typeInterventional

Conditions

ObesityDiabetes mellitus type 2

Requirements

From 18 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT07533175