DRUG
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.
AMAZE 2: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Type 2 Diabetes Lose Weight
Status
Recruiting
Phase
Phase 3
Enrollment
630
Locations
74
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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.
Interventions
Treatment arms and agents.
DRUG
Placebo (matched to NNC0487-0111)
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.
Timeline
From registration to results.
First posted
Apr 16, 2026
Study start
Apr 13, 2026
Primary completion
Aug 7, 2028
Study completion
Aug 7, 2028
Results posted
Not reported
Registry updated
Jul 9, 2026
Outcomes
What the study measures.
Primary outcomes
Relative change in body weight
Time frame · From baseline (week 0) to (week 84)
Measured as percentage (%) of body weight.
Secondary outcomes
Change in waist circumference
Time frame · From baseline (week 0) to (week 84)
Measured as centimetre (cm).
Change in glycated haemoglobin (HbA1c)
Time frame · From baseline (week 0) to (week 84)
Measured as percentage (%) of HbA1c.
Change in systolic blood pressure (SBP)
Time frame · From baseline (week 0) to (week 84)
Measured as millimetre of mercury (mmHg).
Change in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) physical function score
Time frame · From baseline (week 0) to (week 84)
Measured as score on a scale. IWQOL-Lite-CT measures weight-related physical functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. The physical function score ranges from 0-100. Higher scores indicate better levels of functioning.
Change in SF-36v2® Health Survey Acute (SF-36v2 Acute) physical functioning score
Time frame · From baseline (week 0) to (week 84)
Measured as score on a scale. SF-36v2 Acute measures Health-Related Quality of Life (HRQOL). The measure consists of 36 items yielding 8 health domain scores and 2 component summary scores. SF-36v2 Acute scores are norm-based scores, that is transformed to a scale where the 2009 US general population has a mean of 50 and a standard deviation (SD) of 10. The physical functioning ranges from 19.0 to 57.6. Higher scores indicate better functional health and well-being.
Change in body weight
Time frame · From baseline (week 0) to (week 84)
Measured as kilogram (kg).
Change in body mass index (BMI)
Time frame · From baseline (week 0) to (week 84)
Measured as kilograms per meter squared (kg/m\^2).
Change in IWQOL-Lite-CT: Physical, Psychosocial, Total score
Time frame · From baseline (week 0) to (week 84)
Measured as score on a scale. IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. The physical function score ranges from 0-100. Higher scores indicate better levels of functioning.
Achievement of HbA1c < 7.0% (Yes/No)
Time frame · From baseline (week 0) to (week 84)
Measured as number of participants
Achievement of HbA1c ≤ 6.5% (Yes/No)
Time frame · From baseline (week 0) to (week 84)
Measured as number of participants
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
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.
Study locations
74 registered sites.
Argentina · Brazil · Croatia · Hungary · Italy · Mexico · Romania · Slovakia · South Korea · United States. Showing up to 24 locations stored in the fast local snapshot.
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
MICA- Medicina e Investigación Cardiometabólica
Manuel Alberti, Buenos Aires, Argentina
Kynet Recoleta
Buenos Aires, Argentina
Centro médico privado Cemaic
Córdoba, Argentina
CEDIR - Centro de diagnóstico y rehabilitación Santa Fe
Santa Fe, Argentina
Cline Research Center
Curitiba, Paraná, Brazil
PUCCAMP - Hospital e Maternidade Celso Pierro
Campinas, São Paulo, 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
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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