🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in India / NCT07400107
Starting soon Phase 3

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

NCT07400107 · tracked via the Priya Life Science India tracker
Sponsor
Novo Nordisk A/S
Phase
Phase 3
Started
2026-05-20
Last updated
2026-03-12

Condition(s) studied

ObesityOverweightDiabetes Mellitus, Type 2

Investigational drug(s) / intervention(s)

NNC0487-0111SemaglutidePlacebo (matched to NNC0487-0111)Placebo (matched to semaglutide)

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.

Semaglutide: Semaglutide 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 pre- filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.

Placebo (matched to semaglutide): Placebo matched to semaglutide will be administered subcutaneously using 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. Participant will receive 2 injections every week: an active medicine and a placebo, both taken as injections under the skin once a week. The placebo is a treatment with no active medicine in it and will be given to all participants. In addition to placebo, participants will receive either of the active medicine NNC0487-0111 (the treatment being tested) or Semaglutide (an approved and commonly prescribed treatment used as comparator). Which treatment participants get is decided by chance.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Key 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 ≥ 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. Key Exclusion Criteria: * 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.

Primary outcome measure(s)

Trial sites (120)

FacilityCityRegionStatus
Encore Medical Research LLC Hollywood Florida
Optimal Research Sites Orange City Florida
Encore Medical Research of Weston Weston Florida
Endocrine Research Solutions, Inc Roswell Georgia
Elite Clinical Trials Blackfoot Idaho
Endo And Metab Cons Rockville Maryland
Arcturus Healthcare, PLC. Troy Michigan
Velocity Clin Res, Dallas Dallas Texas
Consano Clinical Research, LLC Shavano Park Texas
Selma Medical Associates Winchester Virginia
Centro de Investigaciones Metabólicas Capital Federal Buenos Aires
Centro Médico CIMEL Lanús Este Buenos Aires
Centro Médico Privado San Vicente Diabetes Córdoba Argentina
Núcleo de Pesquisa Clínica do Rio Grande do Sul Ltda. Porto Alegre Rio Grande do Sul
i9 Pesquisas Clínicas Campinas São Paulo
CPQuali Pesquisa Clínica Ltda São Paulo São Paulo
BR Trials - Ensaios Clínicos e Consultoria Ltda. São Paulo São Paulo
Dr. Tatyana Metalova - AIPSMCE EOOD Gotse Delchev Bulgaria
Medical centre Zdrave 1 OOD Kozloduy Bulgaria
UMHAT Pulmed OOD - Pazardzhik, Department of Internal Diseases Pazardzhik Bulgaria
MHAT Heart and Brain EAD - Pleven, Endocrinology and Metabolic Diseases Pleven Bulgaria
DCC I- Pleven EOOD Endocrinology Pleven Bulgaria
MHAT Knyaginya Klementina - Sofia EAD Sofia Bulgaria
MHAT Sveta Sofia EOOD, Department of Endocrinology and Metabolic diseases Sofia Bulgaria
Acibadem City Clinic UMHAT Tokuda EAD, Endocrinology Sofia Bulgaria
USHATE Akad. Ivan Penchev EAD, Second Clinic of Endocrinology Sofia Bulgaria
Medical Institute of Ministry of interior Sofia Bulgaria
Medical Centre - Clinic Nova EOOD Varna Bulgaria
Poliklinika Medikol Zagreb Grad Zagreb Croatia
Opca bolnica Karlovac Karlovac Croatia
Specijalna Bolnica za medicinsku rehabilitaciju Krapinske Toplice_Endocrinology Krapinske Toplice Croatia
Poliklinika SLAVONIJA OSIJEK Osijek Croatia
Clinical Hospital Centre Rijeka_Endocrinology Rijeka Croatia
General Hospital Dr. Josip Bencevic_Diabetic department Slavonski Brod Croatia
Opca bolnica Varazdin_Endocrinology Varaždin Croatia
Poliklinika Solmed Zagreb Croatia
Herz- und Diabeteszentrum NRW - Bad Oeynhausen Bad Oeynhausen Germany
Zentrum fuer klinische Studien Suedbrandenburg GmbH Elsterwerda Germany
Praxis am Markt Dr. Becker Essen Germany
MVZ im Altstadt-Carree Fulda GmbH - Zentrum für klinische Studien Fulda Germany

+ 80 more sites — see the full list on the official registry below.

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 NCT07400107 on ClinicalTrials.gov ↗ ← All trials in India