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 1: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight Lose Weight
Status
Recruiting
Phase
Phase 3
Enrollment
1,150
Locations
72
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. 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 (a 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
Jan 14, 2026
Study start
Feb 24, 2026
Primary completion
Jun 26, 2029
Study completion
Aug 21, 2029
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 and week 136
Measured as centimetre (cm).
Change in systolic blood pressure (SBP)
Time frame · From baseline (week 0) to week 84 and week 136
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 and week 136
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. Higher scores indicate better levels of functioning. The physical function score ranges from 0-100.
Change in SF-36v2® Health Survey Acute (SF-36v2 Acute) physical functioning score
Time frame · From baseline (week 0) to week 84 and week 136
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, i.e. transformed to a scale where the 2009 US general population has a mean of 50 and a standard deviation (SD) of 10. Higher scores indicate better functional health and well-being. The physical functioning ranges from 19.0 to 57.6.
Change in body weight
Time frame · From baseline (week 0) to week 84 and week 136
Measured as kilogram (kg).
Change in body mass index (BMI)
Time frame · From baseline (week 0) to week 84 and week 136
Measured as kilograms per meter squared (kg/m\^2).
Change in IWQOL-Lite-CT physical composite score
Time frame · From baseline (week 0) to week 84 and week 136
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. Higher scores indicate better levels of functioning. The physical composite score ranges from 0-100.
Change in IWQOL-Lite-CT psychosocial composite score
Time frame · From baseline (week 0) to week 84 and week 136
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. Higher scores indicate better levels of functioning. The psychosocial composite score ranges from 0-100.
Change in IWQOL-Lite-CT total score
Time frame · From baseline (week 0) to week 84 and week 136
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. Higher scores indicate better levels of functioning. The total score ranges from 0-100.
Change in glycated haemoglobin (HbA1c)
Time frame · From baseline (week 0) to week 84 and week 136
Measured as percentage of HbA1c.
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
Key Inclusion Criteria: * Male or female (sex at birth). * Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study. * History of at least one self-reported unsuccessful dietary effort to lose body weight. Key Exclusion Criteria: * HbA1c ≥ 6.5% (48 millimole per mole \[mmol/mol\]) as measured by the central laboratory at screening. * History of type 1 or type 2 diabetes mellitus as declared by the participant or reported in the medical records. * 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
72 registered sites.
Argentina · Australia · Belgium · Canada · Denmark · France · Germany · United Kingdom · United States. Showing up to 24 locations stored in the fast local snapshot.
South Broward Research LLC
Miramar, Florida, United States
Clinical Neuroscience Solution
Orlando, Florida, United States
Hope Clin Res & Wellness
Conyers, Georgia, United States
Endeavor Health
Skokie, Illinois, United States
Midwest Inst For Clin Res
Indianapolis, Indiana, United States
StudyMetrix Research LLC
City of Saint Peters, Missouri, United States
New York Gastroenterology Associates
New York, New York, United States
UNC Eastowne Medical Office
Chapel Hill, North Carolina, United States
PharmQuest Life Sciences LLC
Greensboro, North Carolina, United States
Accellacare and KDCILM, LLC
Wilmington, North Carolina, United States
UPA Ctr Weight and Eating Dis
Philadelphia, Pennsylvania, United States
Clinical Res Collaborative
Cumberland, Rhode Island, United States
Medical Uni of SC Charleston
Charleston, South Carolina, United States
Coastal Carolina Research Ctr
North Charleston, South Carolina, United States
Hillcrest Clinical Research
Simpsonville, South Carolina, United States
Amarillo Medical Specialists
Amarillo, Texas, United States
Velocity Clinical Res-Dallas
Dallas, Texas, United States
Care United Research, LLC
Forney, Texas, United States
Washington Cntr Weight Mgmt
Arlington, Virginia, United States
Health Res of Hampton Roads
Newport News, Virginia, United States
Selma Medical Associates
Winchester, Virginia, United States
Rainier Clin Res Ctr Inc
Renton, Washington, United States
Fundación CESIM
Santa Rosa, La Pampa Province, Argentina
Centro Medico Dra. Laura Maffei e Investigacion Clínica Apli
Buenos Aires, Argentina
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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