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)

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity
• Intervention / Treatment: Drug: NNC0487-0111; Drug: Placebo (matched to NNC0487-0111)

• Study Type: Interventional
• Enrollment (Estimated): 600
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Novo Nordisk; Phone Number: (+1) 866-867-7178; Email: clinicaltrials@novonordisk.com

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1119ACN
    • Recruiting
    • CIPREC Pueyrredon
  • Buenos Aires
    • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1018ADE
      • Recruiting
      • Conexa
    • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1424CIQ
      • Recruiting
      • CICEMO- Consultorio (Av Directorio)
    • Mar del Plata, Buenos Aires, Argentina, B7600FZN
      • Recruiting
      • Instituto de Investigaciones Clinicas Mar del Plata
• Australia
  • New South Wales
    • Campbelltown, New South Wales, Australia, 2560
      • Recruiting
      • Sydney Clinical Trials
    • Liverpool, New South Wales, Australia, 2170
      • Recruiting
      • Sydney Cardiometabolic Centre
    • Merewether, New South Wales, Australia, 2291
      • Recruiting
      • Hunter Diabetes Centre
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Recruiting
      • Nightingale Research
• Belgium
  • Diepenbeek, Belgium, 3590
    • Recruiting
    • Anima Research Center
  • Kortrijk, Belgium, 8500
    • Recruiting
    • AZ Groeninge - Kortrijk - Centrum Endo - Diabetologie
  • Liège, Belgium, 4000
    • Not yet recruiting
    • Centre hospitalier universitaire de Liège (CHU de Liège)
  • Ostend, Belgium, 8400
    • Not yet recruiting
    • AZ OOSTENDE (Campus DAMIAAN)
• Bulgaria
  • Lom, Bulgaria, 3600
    • Recruiting
    • DCC 1 - Lom EOOD
  • Plovdiv, Bulgaria, 4000
    • Recruiting
    • MHAT Med Line Clinic
  • Plovdiv, Bulgaria, 4001
    • Recruiting
    • UMHAT Kaspela EOOD, Endocrinology and Metabolic Diseases Clinic
  • Plovdiv, Bulgaria, 4002
    • Recruiting
    • AIPSOMCEMD ENDO MED CONSULT 2020 - Dr. Aleksander Botushanov EOOD
  • Sofia, Bulgaria, 1330
    • Recruiting
    • SGHAT Dr. Shterev EOOD
  • Sofia, Bulgaria, 1431
    • Recruiting
    • UMHAT Aleksandrovska EAD, Clinic of Endocrinology and Metabolic Diseases
  • Sofia, Bulgaria, 1756
    • Recruiting
    • Medical Center Maraya Med EOOD
  • Sofia, Bulgaria, 1839
    • Recruiting
    • AIPSMC Dr. Traykovska EOOD
• Denmark
  • Region Sjælland
    • Køge, Region Sjælland, Denmark, 4600
      • Recruiting
      • Sjællands Universitetshospital, Køge - Medicinsk Afdeling
  • Region Syddanmark
    • Esbjerg, Region Syddanmark, Denmark, 6700
      • Recruiting
      • Sydvestjysk Sygehus Esbjerg - Medicinsk Endokrinologisk Ambulatorium, Forskningsenheden
    • Vejle, Region Syddanmark, Denmark, 7100
      • Recruiting
      • Sanos Clinic - Vejle
• France
  • Clermont-Ferrand, France, 63000
    • Recruiting
    • CHU DE CLERMONT-FERRAND-HOPITAL GABRIEL MONTPIED_Service de Nutrition
  • La Tronche, France, 38700
    • Recruiting
    • CHU GRENOBLE ALPES-SITE NORD MICHALLON_Endocrinologie,diabétologie,maladies de la nutrition
  • Le Creusot, France, 71200
    • Recruiting
    • GROUPE SOS SANTE-HOPITAL LE CREUSOT-HOTEL DIEU_ Service de Diabétologie
  • Lille, France, 59000
    • Recruiting
    • CHU LILLE-HOPITAL CLAUDE HURIEZ_Service de Chirurgie Générale et Endocrinienne
  • Poitiers, France, 86000
    • Recruiting
    • CHU DE POITIERS_Centre d'investigation Clinique
• Germany
  • Hamburg, Germany, 22607
    • Recruiting
    • Wendisch - Dahl Hamburg - DZHW
  • Leipzig, Germany, 04103
    • Recruiting
    • Prof. Dr. Schiefke Ingolf, EUGASTRO GmbH
  • Lingen, Germany, 49808
    • Recruiting
    • Diabetologische Gemeinschaftspraxis Dr. Staudenmeyer und Dr. Schiwietz
  • Münster, Germany, 48145
    • Recruiting
    • Institut für Diabetesforschung GmbH Münster - Dr. med. Rose
  • Oldenburg in Holstein, Germany, 23758
    • Recruiting
    • RED-Institut für medizinische Forschung und Fortbildung GmbH
  • Saint Ingbert-Oberwürzbach, Germany, 66386
    • Recruiting
    • Zentrum für klinische Studien Alexander Segner
  • LÄK Rheinland-Pfalz
    • Speyer, LÄK Rheinland-Pfalz, Germany, 67346
      • Recruiting
      • Diabetologikum - Diabetologische Schwerpunktpraxis Dr. Thomas Segiet
• Italy
  • Bologna, Italy, 40138
    • Not yet recruiting
    • A.O.Universitaria S.ORSOLA-MALPIGHI - U.O.Endocrinologia e Cura
  • Rozzano (MI), Italy, 20089
    • Not yet recruiting
    • IRCCS Humanitas - U.O. Endocrinologia e Diabetologia
  • Emilia-Romagna
    • Ferrara, Emilia-Romagna, Italy, 44124
      • Not yet recruiting
      • Arcispedale Sant'Anna (Cona) - UO di Endocrinologia
  • Liguria
    • Genoa, Liguria, Italy, 16132
      • Not yet recruiting
      • IRCCS Ospedale Policlinico San Martino - Medicina Interna e Specialità Mediche
  • Lombardy
    • Pavia, Lombardy, Italy, 27100
      • Not yet recruiting
      • Fondazione Salvatore Maugeri I.R.C.C.S. - Pavia - Dipartimento Medicina Interna e Generale
  • Sicily
    • Palermo, Sicily, Italy, 90127
      • Not yet recruiting
      • Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone - Presidio Villa Belmonte
  • Veneto
    • Padova, Veneto, Italy, 35128
      • Not yet recruiting
      • Azienda Ospedaliera di Padova - UOSD Chirurgia Bariatrica
    • Verona, Veneto, Italy, 37126
      • Not yet recruiting
      • Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Civile Maggiore Borgo Trento - U.O. Geriatria
• Netherlands
  • Almere Stad, Netherlands, 1311RL
    • Recruiting
    • EB Flevo Research BV
  • Amersfoort, Netherlands, 3813 TZ
    • Not yet recruiting
    • Meander MC
  • Arnhem, Netherlands, 6815 AD
    • Not yet recruiting
    • Rijnstate Ziekenhuis
  • Limburg
    • Born, Limburg, Netherlands, 6121 XK
      • Recruiting
      • PreCare Trial & Recruitment
  • North Brabant
    • 's-Hertogenbosch, North Brabant, Netherlands, 5223 LA
      • Recruiting
      • Progress Clinical Research Den Bosch
• Spain
  • Almería, Spain, 04009
    • Recruiting
    • Centro Periférico de Especialidades Bola Azul
  • Barcelona, Spain, 08036
    • Not yet recruiting
    • Hospital Clinic I Provincial
  • León, Spain, 24008
    • Not yet recruiting
    • H. de León_Endocrinología
  • Madrid, Spain, 28040
    • Not yet recruiting
    • Hospital Clinico San Carlos
  • Málaga, Spain, 29010
    • Recruiting
    • H. Clinico Univ. Virgen de la Victoria
  • Pozuelo de Alarcón, Spain, 28223
    • Recruiting
    • H.U. Quirónsalud Madrid
  • Seville, Spain, 41013
    • Recruiting
    • Hospital Universitario Virgen del Rocio
• United Kingdom
  • Cheshire, United Kingdom, CH65 4LE
    • Recruiting
    • EMS Healthcare
  • Rotherham, United Kingdom, S65 1DA
    • Recruiting
    • Clifton Medical Centre
  • Soham, United Kingdom, CB7 5JD
    • Recruiting
    • Staploe Medical Centre
  • Wellingborough, United Kingdom, NN8 4RW
    • Recruiting
    • Albany House Medical Centre
• United States
  • Alabama
    • Anniston, Alabama, United States, 36207
      • Recruiting
      • Pinnacle Research Group LLC
  • California
    • Walnut Creek, California, United States, 94598
      • Recruiting
      • Diablo Clinical Research, Inc.
  • Florida
    • Orlando, Florida, United States, 32825
      • Recruiting
      • Florida Inst For Clin Res LLC
  • Illinois
    • Skokie, Illinois, United States, 60077
      • Not yet recruiting
      • Endeavor Health
  • Indiana
    • Indianapolis, Indiana, United States, 46260
      • Recruiting
      • Midwest Inst For Clin Res
  • North Carolina
    • Greensboro, North Carolina, United States, 27405
      • Recruiting
      • Medication Mgmnt, LLC_Grnsboro
    • Wilmington, North Carolina, United States, 28401
      • Recruiting
      • PMG Research of Wilmington LLC
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • UPA Ctr Weight and Eating Dis
  • Rhode Island
    • Cumberland, Rhode Island, United States, 02864
      • Recruiting
      • Clinical Res Collaborative
  • Texas
    • Dallas, Texas, United States, 75390-9302
      • Recruiting
      • UT Southwestern Med Cntr
    • Dallas, Texas, United States, 75231
      • Not yet recruiting
      • North Texas Endocrine Center
  • Virginia
    • Winchester, Virginia, United States, 22601-3834
      • Recruiting
      • Selma Medical Associates
  • Washington
    • Renton, Washington, United States, 98057
      • Recruiting
      • Rainier Clin Res Ctr Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NNC0487-0111; Participants will receive subcutaneous injection of NNC0487-0111 once weekly as an adjunct to a reduced-calorie diet and increased physical activity.	Drug: NNC0487-0111; NNC0487-0111 will be administered subcutaneously.
Placebo Comparator: Placebo; Participants will receive subcutaneous injection of placebo matched to NNC0487-0111 once weekly as an adjunct to a reduced-calorie diet and increased physical activity.	Drug: Placebo (matched to NNC0487-0111); Placebo will be administered subcutaneously.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relative change in body weight	Measured as percentage (%) of body weight.	From week 40 to week 92

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relative change in body weight	Measured as % of body weight.	From week 0 to week 92
Change in waist circumference	Measured as centimetre (cm).	From week 40 to week 92
Change in systolic blood pressure (SBP)	Measured as millimeter of mercury (mmHg).	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	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.	From week 40 to week 92
Change in SF-36v2® Health Survey Acute (SF-36v2 Acute) physical functioning score	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.	From week 40 to week 92
Change in body weight	Measured as kilogram (kg).	From week 40 to week 92
Change in body mass index (BMI)	Measured as kilograms per square meter (kg/m^2).	From week 40 to week 92
Change in body weight	Measured as kg.	From week 0 to week 92
Change in BMI	Measured as kg/m^2.	From week 0 to week 92
Change in glycated haemoglobin (HbA1c)	Measured as % of HbA1c.	From week 40 to week 92
Change in fasting plasma glucose (FPG)	Measured as millimoles per liter (mmol/L).	From week 40 to week 92
Change in fasting insulin	Measured as ratio to baseline.	From week 40 to week 92
Change in diastolic blood pressure (DBP)	Measured as mmHg.	From week 40 to week 92
Change in total cholesterol	Measured as ratio to baseline.	From week 40 to week 92
Change in High-density lipoprotein (HDL) cholesterol	Measured as ratio to baseline.	From week 40 to week 92
Change in Low-density lipoprotein (LDL) cholesterol	Measured as ratio to baseline.	From week 40 to week 92
Change in Very low-density lipoprotein (VLDL) cholesterol	Measured as ratio to baseline.	From week 40 to week 92
Change in non-HDL cholesterol	Measured as ratio to baseline.	From week 40 to week 92
Change in triglycerides	Measured as ratio to baseline.	From week 40 to week 92
Change in high-sensitivity C-reactive protein (hsCRP)	Measured as ratio to baseline.	From week 40 to week 92
Change in HbA1c	Measured as % of HbA1c.	From week 0 to week 92
Change in FPG	Measured as mmol/L.	From week 0 to week 92
Change in fasting insulin	Measured as ratio to baseline.	From week 0 to week 92
Change in DBP	Measured as mmHg.	From week 0 to week 92
Change in total cholesterol	Measured as ratio to baseline.	From week 0 to week 92
Change in HDL cholesterol	Measured as ratio to baseline.	From week 0 to week 92
Change in LDL cholesterol	Measured as ratio to baseline.	From week 0 to week 92
Change in VLDL cholesterol	Measured as ratio to baseline.	From week 0 to week 92
Change in non-HDL cholesterol	Measured as ratio to baseline.	From week 0 to week 92
Change in triglycerides	Measured as ratio to baseline.	From week 0 to week 92
Change in hsCRP	Measured as % of hsCRP.	From week 0 to week 92
Change in waist circumference	Measured as cm.	From week 0 to week 92
Change in SBP	Measured as mmHg.	From week 0 to week 92
Change in IWQOL-Lite-CT: physical composite score	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.	From week 40 to week 92
Change in IWQOL-Lite-CT: psychosocial composite score	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.	From week 40 to week 92
Change in IWQOL-Lite-CT: total score	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.	From week 40 to week 92
Number of Treatment Emergent Adverse Events (TEAEs)	Measured as events.	From week 0 to week 40
Number of Treatment Emergent Serious Adverse Events (TESAEs)	Measured as events.	From week 0 to week 40
Number of TEAEs leading to permanent treatment discontinuation	Measured as events.	From week 0 to week 40
Number of TEAEs	Measured as events.	From week 40 to week 96
Number of TESAEs	Measured as events.	From week 40 to week 96
Number of TEAEs leading to permanent treatment discontinuation	Measured as events.	From week 40 to week 96

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2026
• Primary Completion (Estimated): June 6, 2028
• Study Completion (Estimated): July 4, 2028

Study Registration Dates

• First Submitted: March 25, 2026
• First Submitted That Met QC Criteria: March 25, 2026
• First Posted (Actual): March 31, 2026

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 18, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity
• Other Study ID Numbers: NN9490-8559; U1111-1327-1477 (Other Identifier: World Health Organization (WHO)); 2025-523804-62 (Other Identifier: European Medical Agency (EMA))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No