AMAZE 12: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight Maintain Their Weight Loss
AMAZE 12
Efficacy and Safety of NNC0487-0111 s.c. Once Weekly in Participants With Obesity Who Have Reached Target Dose During run-in Period (AMAZE 12)
4 other identifiers
interventional
606
12 countries
72
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 obesity
Started Apr 2026
Typical duration for phase_3 obesity
72 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 25, 2026
CompletedFirst Posted
Study publicly available on registry
March 31, 2026
CompletedStudy Start
First participant enrolled
April 21, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 6, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 4, 2028
September 11, 2026
September 1, 2026
2.1 years
March 25, 2026
September 10, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Relative change in body weight
Measured as percentage (%) of body weight.
From week 40 to week 92
Secondary Outcomes (42)
Relative change in body weight
From week 0 to week 92
Change in waist circumference
From week 40 to week 92
Change in systolic blood pressure (SBP)
From week 40 to week 92
Change in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) physical function score
From week 40 to week 92
Change in SF-36v2® Health Survey Acute (SF-36v2 Acute) physical functioning score
From week 40 to week 92
- +37 more secondary outcomes
Study Arms (2)
NNC0487-0111
EXPERIMENTALParticipants will receive subcutaneous injection of NNC0487-0111 once weekly as an adjunct to a reduced-calorie diet and increased physical activity.
Placebo
PLACEBO COMPARATORParticipants will receive subcutaneous injection of placebo matched to NNC0487-0111 once weekly as an adjunct to a reduced-calorie diet and increased physical activity.
Interventions
Eligibility Criteria
You may qualify if:
- Male or female (sex at birth).
- Age 18 years or above at the time of signing the informed consent.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (72)
Pinnacle Research Group LLC
Anniston, Alabama, 36207, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598, United States
Florida Inst For Clin Res LLC
Orlando, Florida, 32825, United States
Endeavor Health
Skokie, Illinois, 60077, United States
Midwest Inst For Clin Res
Indianapolis, Indiana, 46260, United States
Medication Mgmnt, LLC_Grnsboro
Greensboro, North Carolina, 27405, United States
PMG Research of Wilmington LLC
Wilmington, North Carolina, 28401, United States
UPA Ctr Weight and Eating Dis
Philadelphia, Pennsylvania, 19104, United States
Clinical Res Collaborative
Cumberland, Rhode Island, 02864, United States
North Texas Endocrine Center
Dallas, Texas, 75231, United States
UT Southwestern Med Cntr
Dallas, Texas, 75390-9302, United States
Selma Medical Associates
Winchester, Virginia, 22601-3834, United States
Rainier Clin Res Ctr Inc
Renton, Washington, 98057, United States
Conexa
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1018ADE, Argentina
CICEMO- Consultorio (Av Directorio)
Ciudad Autónoma de Buenos Aires, Buenos Aires, C1424CIQ, Argentina
Instituto de Investigaciones Clinicas Mar Del Plata
Mar del Plata, Buenos Aires, B7600FZN, Argentina
CIPREC Pueyrredon
Buenos Aires, C1119ACN, Argentina
Sydney Clinical Trials
Campbelltown, New South Wales, 2560, Australia
Sydney Cardiometabolic Centre
Liverpool, New South Wales, 2170, Australia
Hunter Diabetes Centre
Merewether, New South Wales, 2291, Australia
Nightingale Research Adelaide
Adelaide, South Australia, 5000, Australia
Anima Research Center
Diepenbeek, 3590, Belgium
AZ Groeninge - Kortrijk - Centrum Endo - Diabetologie
Kortrijk, 8500, Belgium
Centre hospitalier universitaire de Liège (CHU de Liège)
Liège, 4000, Belgium
AZ OOSTENDE (Campus DAMIAAN)
Ostend, 8400, Belgium
DCC 1 - Lom EOOD
Lom, 3600, Bulgaria
MHAT Med Line Clinic
Plovdiv, 4000, Bulgaria
UMHAT Kaspela EOOD, Endocrinology and Metabolic Diseases Clinic
Plovdiv, 4001, Bulgaria
AIPSOMCEMD ENDO MED CONSULT 2020 - Dr. Aleksander Botushanov EOOD
Plovdiv, 4002, Bulgaria
SGHAT Dr. Shterev EOOD
Sofia, 1330, Bulgaria
UMHAT Aleksandrovska EAD, Clinic of Endocrinology and Metabolic Diseases
Sofia, 1431, Bulgaria
Medical Center Maraya Med EOOD
Sofia, 1756, Bulgaria
AIPSMC Dr. Traykovska EOOD
Sofia, 1839, Bulgaria
Sjællands Universitetshospital, Køge - Medicinsk Afdeling
Køge, Region Sjælland, 4600, Denmark
Sydvestjysk Sygehus Esbjerg - Medicinsk Endokrinologisk Ambulatorium, Forskningsenheden
Esbjerg, Region Syddanmark, 6700, Denmark
Sanos Clinic - Vejle
Vejle, Region Syddanmark, 7100, Denmark
CHU DE CLERMONT-FERRAND-HOPITAL GABRIEL MONTPIED_Service de Nutrition
Clermont-Ferrand, 63000, France
CHU GRENOBLE ALPES-SITE NORD MICHALLON_Endocrinologie,diabétologie,maladies de la nutrition
La Tronche, 38700, France
GROUPE SOS SANTE-HOPITAL LE CREUSOT-HOTEL DIEU_ Service de Diabétologie
Le Creusot, 71200, France
CHU LILLE-HOPITAL CLAUDE HURIEZ_Service de Chirurgie Générale et Endocrinienne
Lille, 59000, France
CHU DE POITIERS_Centre d'investigation Clinique
Poitiers, 86000, France
Diabetologikum - Diabetologische Schwerpunktpraxis Dr. Thomas Segiet
Speyer, LÄK Rheinland-Pfalz, 67346, Germany
Wendisch - Dahl Hamburg - DZHW
Hamburg, 22607, Germany
Prof. Dr. Schiefke Ingolf, EUGASTRO GmbH
Leipzig, 04103, Germany
Diabetologische Gemeinschaftspraxis Dr. Staudenmeyer und Dr. Schiwietz
Lingen, 49808, Germany
Institut für Diabetesforschung GmbH Münster - Dr. med. Rose
Münster, 48145, Germany
RED-Institut für medizinische Forschung und Fortbildung GmbH
Oldenburg in Holstein, 23758, Germany
Zentrum für klinische Studien Alexander Segner
Saint Ingbert-Oberwürzbach, 66386, Germany
Arcispedale Sant'Anna (Cona) - UO di Endocrinologia
Ferrara, Emilia-Romagna, 44124, Italy
IRCCS Ospedale Policlinico San Martino - Medicina Interna e Specialità Mediche
Genoa, Liguria, 16132, Italy
Fondazione Salvatore Maugeri I.R.C.C.S. - Pavia - Dipartimento Medicina Interna e Generale
Pavia, Lombardy, 27100, Italy
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone - Presidio Villa Belmonte
Palermo, Sicily, 90142, Italy
Azienda Ospedaliera di Padova - UOSD Chirurgia Bariatrica
Padova, Veneto, 35128, Italy
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Civile Maggiore Borgo Trento - U.O. Geriatria
Verona, Veneto, 37126, Italy
A.O.Universitaria S.ORSOLA-MALPIGHI - U.O.Endocrinologia e Cura
Bologna, 40138, Italy
IRCCS Humanitas - U.O. Endocrinologia e Diabetologia
Rozzano (MI), 20089, Italy
PreCare Trial & Recruitment
Born, Limburg, 6121 XK, Netherlands
Progress Clinical Research Den Bosch
's-Hertogenbosch, North Brabant, 5223 LA, Netherlands
EB Flevo Research BV
Almere Stad, 1311RL, Netherlands
Meander MC
Amersfoort, 3813 TZ, Netherlands
Rijnstate Ziekenhuis
Arnhem, 6815 AD, Netherlands
Centro Periferico De Especialidades Bola Azul
Almería, 04009, Spain
Hospital Clinic i Provincial
Barcelona, 08036, Spain
H. de León_Endocrinología
León, 24008, Spain
Hospital Clínico San Carlos
Madrid, 28040, Spain
H. Clinico Univ. Virgen de la Victoria
Málaga, 29010, Spain
H.U. Quirónsalud Madrid
Pozuelo de Alarcón, 28223, Spain
Hospital Universitario Virgen del Rocío
Seville, 41013, Spain
EMS Healthcare
Macclesfield, North West England, SK10 4TF, United Kingdom
Clifton Medical Centre
Rotherham, S65 1DA, United Kingdom
Staploe Medical Centre
Soham, CB7 5JD, United Kingdom
Albany House Medical Centre
Wellingborough, NN8 4RW, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Transparency (dept. 2834)
Novo Nordisk A/S
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Sponsor staff involved in the clinical trial is masked according to company standard procedures.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 25, 2026
First Posted
March 31, 2026
Study Start
April 21, 2026
Primary Completion (Estimated)
June 6, 2028
Study Completion (Estimated)
July 4, 2028
Last Updated
September 11, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will share
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com