Last updated 21 days ago

AMAZE 8: A Research Study Investigating How Well the Medicine NNC0487-0111 Compared to Semaglutide Helps People With Excess Body Weight and Type 2 Diabetes Lose Weight

1000 patients around the world

Available in Argentina, United States, Mexico, Brazil

Novo Nordisk A/S

8Research sites

1000Patients 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 ≥ 180 days before screening.
Haemoglobin A1c (HbA1c) 7-10 percentage (%) (53-86 millimole per mole [mmol/mol]) (both inclusive) as measured by the central laboratory at 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.

: Renal impairment with estimated Glomerular Filtration Rate (eGFR) < 30 milliliter (mL)/ minute (min)/1.73 meter squared (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) within 180 days before screening or are expected to require treatment within 180 days 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 randomization.
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 de Investigaciones Metabólicas (CINME) S.A. - CABA, Buenos Aires

Viamonte 2213, C1056ABI Cdad. Autónoma de Buenos Aires, Argentina

Centro Médico Privado San Vicente Diabetes - Córdoba

Entre Ríos 2977, Córdoba

Centro Médico Cimel Chahin Chahin S.A.

Tucumán 1314, Lanús, Buenos Aires

CPQuali Pesquisa Clínica

Avenida Angélica, 916 Conjunto 506 - São Paulo 01228-000

Núcleo de Pesquisa Clínica do Rio Grande do Sul - NPCRS

Rua Mostardeiro 5/310, Porto Alegre, Rio Grande do Sul

BR Trials - Pesquisa Clínica - Sao Paulo

Av. Arnolfo Azevedo, 40 - Pacaembu, São Paulo - SP, 01236-030, Brazil

Diseño y Planeación en Investigación Médica

Jose Maria Morelos 2203, Guadalajara, Jalisco

Centro de Estudios de Investigación Metabólica y Cardiovascular SC

Diagonal Sur - Nte 305, Colinas de Universidad, 89110 Tampico, Tamps., Mexico

StudyAMAZE 8

SponsorNovo Nordisk A/S

Study typeInterventional

Conditions

ObesityDiabetes mellitus type 2

Requirements

From 18 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT07400107