RecruitingPhase 3NCT07503210

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

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)


Sponsor

Novo Nordisk A/S

Enrollment

600 participants

Start Date

Apr 21, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria2

  • Male or female (sex at birth).
  • Age 18 years or above at the time of signing the informed consent.

Exclusion Criteria3

  • 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.

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Interventions

DRUGNNC0487-0111

NNC0487-0111 will be administered subcutaneously.

DRUGPlacebo (matched to NNC0487-0111)

Placebo will be administered subcutaneously.


Locations(72)

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

AZ OOSTENDE (Campus DAMIAAN)

Ostend, Belgium

DCC 1 - Lom EOOD

Lom, Bulgaria

MHAT Med Line Clinic

Plovdiv, Bulgaria

UMHAT Kaspela EOOD, Endocrinology and Metabolic Diseases Clinic

Plovdiv, Bulgaria

AIPSOMCEMD ENDO MED CONSULT 2020 - Dr. Aleksander Botushanov EOOD

Plovdiv, Bulgaria

SGHAT Dr. Shterev EOOD

Sofia, Bulgaria

UMHAT Aleksandrovska EAD, Clinic of Endocrinology and Metabolic Diseases

Sofia, Bulgaria

Medical Center Maraya Med EOOD

Sofia, Bulgaria

AIPSMC Dr. Traykovska EOOD

Sofia, Bulgaria

Sjællands Universitetshospital, Køge - Medicinsk Afdeling

Køge, Region Sjælland, Denmark

Sydvestjysk Sygehus Esbjerg - Medicinsk Endokrinologisk Ambulatorium, Forskningsenheden

Esbjerg, Region Syddanmark, Denmark

Sanos Clinic - Vejle

Vejle, Region Syddanmark, Denmark

CHU DE CLERMONT-FERRAND-HOPITAL GABRIEL MONTPIED_Service de Nutrition

Clermont-Ferrand, France

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

La Tronche, France

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

Le Creusot, France

CHU LILLE-HOPITAL CLAUDE HURIEZ_Service de Chirurgie Générale et Endocrinienne

Lille, France

CHU DE POITIERS_Centre d'investigation Clinique

Poitiers, France

Diabetologikum - Diabetologische Schwerpunktpraxis Dr. Thomas Segiet

Speyer, LÄK Rheinland-Pfalz, Germany

Wendisch - Dahl Hamburg - DZHW

Hamburg, Germany

Prof. Dr. Schiefke Ingolf, EUGASTRO GmbH

Leipzig, Germany

Diabetologische Gemeinschaftspraxis Dr. Staudenmeyer und Dr. Schiwietz

Lingen, Germany

Institut für Diabetesforschung GmbH Münster - Dr. med. Rose

Münster, Germany

RED-Institut für medizinische Forschung und Fortbildung GmbH

Oldenburg in Holstein, Germany

Zentrum für klinische Studien Alexander Segner

Saint Ingbert-Oberwürzbach, Germany

Arcispedale Sant'Anna (Cona) - UO di Endocrinologia

Ferrara, Emilia-Romagna, Italy

IRCCS Ospedale Policlinico San Martino - Medicina Interna e Specialità Mediche

Genoa, Liguria, Italy

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

Pavia, Lombardy, Italy

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone - Presidio Villa Belmonte

Palermo, Sicily, Italy

Azienda Ospedaliera di Padova - UOSD Chirurgia Bariatrica

Padova, Veneto, Italy

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

Verona, Veneto, Italy

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

Bologna, Italy

IRCCS Humanitas - U.O. Endocrinologia e Diabetologia

Rozzano (MI), Italy

PreCare Trial & Recruitment

Born, Limburg, Netherlands

Progress Clinical Research Den Bosch

's-Hertogenbosch, North Brabant, Netherlands

EB Flevo Research BV

Almere Stad, Netherlands

Meander MC

Amersfoort, Netherlands

Rijnstate Ziekenhuis

Arnhem, Netherlands

Centro Periferico De Especialidades Bola Azul

Almería, Spain

Hospital Clinic i Provincial

Barcelona, Spain

H. de León_Endocrinología

León, Spain

Hospital Clínico San Carlos

Madrid, Spain

H. Clinico Univ. Virgen de la Victoria

Málaga, Spain

H.U. Quirónsalud Madrid

Pozuelo de Alarcón, Spain

Hospital Universitario Virgen del Rocío

Seville, Spain

EMS Healthcare

Cheshire, United Kingdom

Clifton Medical Centre

Rotherham, United Kingdom

Staploe Medical Centre

Soham, United Kingdom

Albany House Medical Centre

Wellingborough, United Kingdom

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NCT07503210


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