AMAZE 12: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight Maintain Their Weight Loss

NCT07503210 | Recruiting Phase 3 FDA Drug

• 3 other identifiers: NN9490-8559U1111-1327-14772025-523804-62
• Study Type: interventional
• Target: 600
• Locations: 12 countries
• Sites: 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.

Conditions

Obesity

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

Study Arms (2)

NNC0487-0111

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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)

Interventions

NNC0487-0111 DRUG

NNC0487-0111 will be administered subcutaneously.

NNC0487-0111

Placebo (matched to NNC0487-0111) DRUG

Placebo will be administered subcutaneously.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (72)

Pinnacle Research Group LLC

Anniston, Alabama, 36207, United States

RECRUITING

Diablo Clinical Research, Inc.

Walnut Creek, California, 94598, United States

RECRUITING

Florida Inst For Clin Res LLC

Orlando, Florida, 32825, United States

RECRUITING

Endeavor Health

Skokie, Illinois, 60077, United States

NOT YET RECRUITING

Midwest Inst For Clin Res

Indianapolis, Indiana, 46260, United States

RECRUITING

Medication Mgmnt, LLC_Grnsboro

Greensboro, North Carolina, 27405, United States

RECRUITING

PMG Research of Wilmington LLC

Wilmington, North Carolina, 28401, United States

RECRUITING

UPA Ctr Weight and Eating Dis

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Clinical Res Collaborative

Cumberland, Rhode Island, 02864, United States

RECRUITING

North Texas Endocrine Center

Dallas, Texas, 75231, United States

NOT YET RECRUITING

UT Southwestern Med Cntr

Dallas, Texas, 75390-9302, United States

RECRUITING

Selma Medical Associates

Winchester, Virginia, 22601-3834, United States

RECRUITING

Rainier Clin Res Ctr Inc

Renton, Washington, 98057, United States

RECRUITING

Conexa

Ciudad Autonoma de Buenos Aires, Buenos Aires, C1018ADE, Argentina

RECRUITING

CICEMO- Consultorio (Av Directorio)

Ciudad Autónoma de Buenos Aires, Buenos Aires, C1424CIQ, Argentina

RECRUITING

Instituto de Investigaciones Clinicas Mar Del Plata

Mar del Plata, Buenos Aires, B7600FZN, Argentina

RECRUITING

CIPREC Pueyrredon

Buenos Aires, C1119ACN, Argentina

RECRUITING

Sydney Clinical Trials

Campbelltown, New South Wales, 2560, Australia

RECRUITING

Sydney Cardiometabolic Centre

Liverpool, New South Wales, 2170, Australia

RECRUITING

Hunter Diabetes Centre

Merewether, New South Wales, 2291, Australia

RECRUITING

Nightingale Research

Adelaide, South Australia, 5000, Australia

RECRUITING

Anima Research Center

Diepenbeek, 3590, Belgium

RECRUITING

AZ Groeninge - Kortrijk - Centrum Endo - Diabetologie

Kortrijk, 8500, Belgium

RECRUITING

Centre hospitalier universitaire de Liège (CHU de Liège)

Liège, 4000, Belgium

NOT YET RECRUITING

AZ OOSTENDE (Campus DAMIAAN)

Ostend, 8400, Belgium

NOT YET RECRUITING

DCC 1 - Lom EOOD

Lom, 3600, Bulgaria

RECRUITING

MHAT Med Line Clinic

Plovdiv, 4000, Bulgaria

RECRUITING

UMHAT Kaspela EOOD, Endocrinology and Metabolic Diseases Clinic

Plovdiv, 4001, Bulgaria

RECRUITING

AIPSOMCEMD ENDO MED CONSULT 2020 - Dr. Aleksander Botushanov EOOD

Plovdiv, 4002, Bulgaria

RECRUITING

SGHAT Dr. Shterev EOOD

Sofia, 1330, Bulgaria

RECRUITING

UMHAT Aleksandrovska EAD, Clinic of Endocrinology and Metabolic Diseases

Sofia, 1431, Bulgaria

RECRUITING

Medical Center Maraya Med EOOD

Sofia, 1756, Bulgaria

RECRUITING

AIPSMC Dr. Traykovska EOOD

Sofia, 1839, Bulgaria

RECRUITING

Sjællands Universitetshospital, Køge - Medicinsk Afdeling

Køge, Region Sjælland, 4600, Denmark

RECRUITING

Sydvestjysk Sygehus Esbjerg - Medicinsk Endokrinologisk Ambulatorium, Forskningsenheden

Esbjerg, Region Syddanmark, 6700, Denmark

RECRUITING

Sanos Clinic - Vejle

Vejle, Region Syddanmark, 7100, Denmark

RECRUITING

CHU DE CLERMONT-FERRAND-HOPITAL GABRIEL MONTPIED_Service de Nutrition

Clermont-Ferrand, 63000, France

RECRUITING

CHU GRENOBLE ALPES-SITE NORD MICHALLON_Endocrinologie,diabétologie,maladies de la nutrition

La Tronche, 38700, France

RECRUITING

GROUPE SOS SANTE-HOPITAL LE CREUSOT-HOTEL DIEU_ Service de Diabétologie

Le Creusot, 71200, France

RECRUITING

CHU LILLE-HOPITAL CLAUDE HURIEZ_Service de Chirurgie Générale et Endocrinienne

Lille, 59000, France

RECRUITING

CHU DE POITIERS_Centre d'investigation Clinique

Poitiers, 86000, France

RECRUITING

Diabetologikum - Diabetologische Schwerpunktpraxis Dr. Thomas Segiet

Speyer, LÄK Rheinland-Pfalz, 67346, Germany

RECRUITING

Wendisch - Dahl Hamburg - DZHW

Hamburg, 22607, Germany

RECRUITING

Prof. Dr. Schiefke Ingolf, EUGASTRO GmbH

Leipzig, 04103, Germany

RECRUITING

Diabetologische Gemeinschaftspraxis Dr. Staudenmeyer und Dr. Schiwietz

Lingen, 49808, Germany

RECRUITING

Institut für Diabetesforschung GmbH Münster - Dr. med. Rose

Münster, 48145, Germany

RECRUITING

RED-Institut für medizinische Forschung und Fortbildung GmbH

Oldenburg in Holstein, 23758, Germany

RECRUITING

Zentrum für klinische Studien Alexander Segner

Saint Ingbert-Oberwürzbach, 66386, Germany

RECRUITING

Arcispedale Sant'Anna (Cona) - UO di Endocrinologia

Ferrara, Emilia-Romagna, 44124, Italy

NOT YET RECRUITING

IRCCS Ospedale Policlinico San Martino - Medicina Interna e Specialità Mediche

Genoa, Liguria, 16132, Italy

NOT YET RECRUITING

Fondazione Salvatore Maugeri I.R.C.C.S. - Pavia - Dipartimento Medicina Interna e Generale

Pavia, Lombardy, 27100, Italy

NOT YET RECRUITING

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone - Presidio Villa Belmonte

Palermo, Sicily, 90127, Italy

NOT YET RECRUITING

Azienda Ospedaliera di Padova - UOSD Chirurgia Bariatrica

Padova, Veneto, 35128, Italy

NOT YET RECRUITING

Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Civile Maggiore Borgo Trento - U.O. Geriatria

Verona, Veneto, 37126, Italy

NOT YET RECRUITING

A.O.Universitaria S.ORSOLA-MALPIGHI - U.O.Endocrinologia e Cura

Bologna, 40138, Italy

NOT YET RECRUITING

IRCCS Humanitas - U.O. Endocrinologia e Diabetologia

Rozzano (MI), 20089, Italy

NOT YET RECRUITING

PreCare Trial & Recruitment

Born, Limburg, 6121 XK, Netherlands

RECRUITING

Progress Clinical Research Den Bosch

's-Hertogenbosch, North Brabant, 5223 LA, Netherlands

RECRUITING

EB Flevo Research BV

Almere Stad, 1311RL, Netherlands

RECRUITING

Meander MC

Amersfoort, 3813 TZ, Netherlands

NOT YET RECRUITING

Rijnstate Ziekenhuis

Arnhem, 6815 AD, Netherlands

NOT YET RECRUITING

Centro Periferico De Especialidades Bola Azul

Almería, 04009, Spain

RECRUITING

Hospital Clinic i Provincial

Barcelona, 08036, Spain

NOT YET RECRUITING

H. de León_Endocrinología

León, 24008, Spain

NOT YET RECRUITING

Hospital Clínico San Carlos

Madrid, 28040, Spain

NOT YET RECRUITING

H. Clinico Univ. Virgen de la Victoria

Málaga, 29010, Spain

RECRUITING

H.U. Quirónsalud Madrid

Pozuelo de Alarcón, 28223, Spain

RECRUITING

Hospital Universitario Virgen del Rocío

Seville, 41013, Spain

RECRUITING

EMS Healthcare

Cheshire, CH65 4LE, United Kingdom

RECRUITING

Clifton Medical Centre

Rotherham, S65 1DA, United Kingdom

RECRUITING

Staploe Medical Centre

Soham, CB7 5JD, United Kingdom

RECRUITING

Albany House Medical Centre

Wellingborough, NN8 4RW, United Kingdom

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Central Study Contacts

Novo Nordisk

CONTACT

(+1) 866-867-7178; clinicaltrials@novonordisk.com

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: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

ES (7); AR (4); DK (3); FR (5); NL (5); DE (7); AU (4); BE (4); BU (8); GB (4); US (13); IT (8)