DRUG
NNC0487-0111
NNC0487-0111 will be administered subcutaneously.
AMAZE 12: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight Maintain Their Weight Loss
Status
Recruiting
Phase
Phase 3
Enrollment
600
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 will be administered subcutaneously.
Timeline
From registration to results.
First posted
Mar 31, 2026
Study start
Apr 21, 2026
Primary completion
Jun 6, 2028
Study completion
Jul 4, 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 week 40 to week 92
Measured as percentage (%) of body weight.
Secondary outcomes
Relative change in body weight
Time frame · From week 0 to week 92
Measured as % of body weight.
Change in waist circumference
Time frame · From week 40 to week 92
Measured as centimetre (cm).
Change in systolic blood pressure (SBP)
Time frame · From week 40 to week 92
Measured as millimeter 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 week 40 to week 92
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 week 40 to week 92
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 week 40 to week 92
Measured as kilogram (kg).
Change in body mass index (BMI)
Time frame · From week 40 to week 92
Measured as kilograms per square meter (kg/m\^2).
Change in body weight
Time frame · From week 0 to week 92
Measured as kg.
Change in BMI
Time frame · From week 0 to week 92
Measured as kg/m\^2.
Change in glycated haemoglobin (HbA1c)
Time frame · From week 40 to week 92
Measured as % of HbA1c.
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 the informed consent. Exclusion Criteria: * Glycated haemoglobin (HbA1c) greater than or equal to ≥ 6.5% \[48 millimoles per mole (mmol/mol)\] 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 · Bulgaria · Denmark · France · Germany · Italy · Netherlands · Spain · United Kingdom · United States. Showing up to 24 locations stored in the fast local snapshot.
Pinnacle Research Group LLC
Anniston, Alabama, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, United States
Florida Inst For Clin Res LLC
Orlando, Florida, United States
Endeavor Health
Skokie, Illinois, United States
Midwest Inst For Clin Res
Indianapolis, Indiana, United States
Medication Mgmnt, LLC_Grnsboro
Greensboro, North Carolina, United States
PMG Research of Wilmington LLC
Wilmington, North Carolina, United States
UPA Ctr Weight and Eating Dis
Philadelphia, Pennsylvania, United States
Clinical Res Collaborative
Cumberland, Rhode Island, United States
North Texas Endocrine Center
Dallas, Texas, United States
UT Southwestern Med Cntr
Dallas, Texas, United States
Selma Medical Associates
Winchester, Virginia, United States
Rainier Clin Res Ctr Inc
Renton, Washington, United States
Conexa
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
CICEMO- Consultorio (Av Directorio)
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Instituto de Investigaciones Clinicas Mar Del Plata
Mar del Plata, Buenos Aires, Argentina
CIPREC Pueyrredon
Buenos Aires, Argentina
Sydney Clinical Trials
Campbelltown, New South Wales, Australia
Sydney Cardiometabolic Centre
Liverpool, New South Wales, Australia
Hunter Diabetes Centre
Merewether, New South Wales, Australia
Nightingale Research
Adelaide, South Australia, Australia
Anima Research Center
Diepenbeek, Belgium
AZ Groeninge - Kortrijk - Centrum Endo - Diabetologie
Kortrijk, Belgium
Centre hospitalier universitaire de Liège (CHU de Liège)
Liège, Belgium
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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Put the record in context.
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