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 · NCT07533175 · Interventional (participants receive a specific treatment) · Lead sponsor: Novo Nordisk A/S
View the official record on ClinicalTrials.gov →Interventions studied
NNC0487-0111Placebo (matched to NNC0487-0111)
What this trial 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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
60 locations listed across 9 US states.
- Univ of Alabama Birmingham - Birmingham, Alabama, United States
- Headlands Research California, LLC - Escondido, California, United States
- Torrance Clinical Research Institute, Inc. - Lomita, California, United States
- Diablo Clinical Research, Inc. - Walnut Creek, California, United States
- Northeast Research Institute - Fleming Island, Florida, United States
- Jacksonville Ctr Clin Res - Jacksonville, Florida, United States
- Florida Institute for Clinical Research, LLC - Orlando, Florida, United States
- Oviedo Medical Research, LLC - Oviedo, Florida, United States
- International Diabetes Center - Minneapolis, Minnesota, United States
- Southgate Medical Group, LLP - West Seneca, New York, United States
- Spartanburg Medical Research - Spartanburg, South Carolina, United States
- M3 Wake Research Chattanooga - Chattanooga, Tennessee, United States
- UT Southwestern Med Center - Dallas, Texas, United States
- PlanIt Research, PLLC - Houston, Texas, United States
- National Clin Res Inc. - Richmond, Virginia, United States
- CMI Dr. Pletea Noemi SRL - Bacau, Romania
- DRC Kft. - Balatonfüred, Hungary
- SC Nutrilife SRL - Bucharest, Romania
- SC Clinica Diabnutrimed S.R.L. - Bucharest, Romania
- Diabet Med SRL - Bucharest, Romania
- Szent Margit Rendelőintézet Nonprofit Kft. - Budapest, Hungary
- Semmelweis Egyetem - Budapest, Hungary
- PVN Kutató Kft. - Budapest, Hungary
- Észak-Pesti Centrumkórház Honvédkórház - Diabetológia Szakrendelés - Budapest, Hungary
- Trantor 99 Bt - Budapest, Hungary
- Kynet Recoleta - Buenos Aires, Argentina
- Cmi Dr. Cojocaru Cristina - Constanța, Romania
- A&C Medical Prime S.R.L. - Craiova, Romania
- Centro médico privado Cemaic - Córdoba, Argentina
- Chonnam National University Hospital_Endocrinology - Gwangju, South Korea
- Somogy Vármegyei Kaposi Mór Oktató Kórház - Kaposvár, Hungary
- Opca bolnica Karlovac - Karlovac, Croatia
- Specijalna Bolnica za medicinsku rehabilitaciju Krapinske Toplice_Endocrinology - Krapinske Toplice, Croatia
- DIA - KONTROL s.r.o. - Levice, Slovakia
- IRCCS Ospedale San Raffaele Milano - Milan, Italy
- Specijalna bolnica Thalassotherapia - Opatija, Croatia
- Poliklinika SLAVONIJA OSIJEK - Osijek, Croatia
- Consultorio de Endocrinología y Pediatría - Puebla City, Mexico
- Opca bolnica Pula - Pula, Croatia
- OLIVER - MED s.r.o. - Rimavská Sobota, Slovakia
- CEDIR - Centro de diagnóstico y rehabilitación Santa Fe - Santa Fe, Argentina
- Spital Judetean De Urgenta Satu Mare - Satu Mare, Romania
- Kyunghee University Medical Center_Endocrinology - Seoul, South Korea
- Seoul National University Hospital_Endocrinology - Seoul, South Korea
- Severance Hospital, Yonsei University Health System_Endocrinology - Seoul, South Korea
- Asan Medical Center_Endocrinology - Seoul, South Korea
- The Catholic University of Korea, Yeouido ST. Mary's Hospital_Endocrinology - Seoul, South Korea
- Poliklinika za oftalmologiju optometriju i neurologiju Lux - Solin, Croatia
- ARETEUS s.r.o. - Trebišov, Slovakia
- ARETEUS s.r.o. - Trebišov, Slovakia
- Opca bolnica Varazdin_Endocrinology - Varaždin, Croatia
- Poliklinika Solmed - Zagreb, Croatia
- Narodny Endokrinologicky a diabetologicky ustav - Ľubochňa, Slovakia
- Peter Farkas MD, s.r.o. - Šahy, Slovakia
- DEImedi, s. r. o. - Šurany, Slovakia
- MICA- Medicina e Investigación Cardiometabólica - Manuel Alberti, Buenos Aires, Argentina
- Szegedi Tudomanyegyetem St Györgyi Albert Klinikai Központ - Szeged, Csongrád-Csanád, Hungary
- S.C. Top Diabet Srl - Craiova, Dolj, Romania
- Dip. Med. Chir. delle malattie digestive, epatiche ed endo-meta - UOC Endocrinologia e prevenzione e cura del diabete - Bologna, Emilia-Romagna, Italy
- Seoul National University Bundang Hospital_Endocrinology - Seoungnam-si, Gyeonggi-do, South Korea
Showing 60 of 74 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →