Clinical trial

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

Recruiting now · Phase 3 · 8 countries · Registry ID NCT07503210

Recruiting nowPhase 3Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed
SexAll
Healthy volunteersNot accepted
ConditionObesity

Full registry criteria

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.

Treatments and study arms

NNC0487-0111

Drug

NNC0487-0111 will be administered subcutaneously.

Placebo (matched to NNC0487-0111)

Drug

Placebo will be administered subcutaneously.

Primary outcomes

Relative change in body weightFrom week 40 to week 92

Measured as percentage (%) of body weight.

Study locations

72 locations were listed when this page was built. The first 40 are shown.

CIPREC Pueyrredon🇦🇷 Buenos Aires, Argentina
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
Nightingale Research Adelaide🇦🇺 Adelaide, South Australia, Australia
Sydney Clinical Trials🇦🇺 Campbelltown, New South Wales, Australia
Sydney Cardiometabolic Centre🇦🇺 Liverpool, New South Wales, Australia
Hunter Diabetes Centre🇦🇺 Merewether, New South Wales, 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
AIPSOMCEMD ENDO MED CONSULT 2020 - Dr. Aleksander Botushanov EOOD🌐 Plovdiv, Bulgaria
MHAT Med Line Clinic🌐 Plovdiv, Bulgaria
UMHAT Kaspela EOOD, Endocrinology and Metabolic Diseases Clinic🌐 Plovdiv, Bulgaria
AIPSMC Dr. Traykovska EOOD🌐 Sofia, Bulgaria
Medical Center Maraya Med EOOD🌐 Sofia, Bulgaria
SGHAT Dr. Shterev EOOD🌐 Sofia, Bulgaria
UMHAT Aleksandrovska EAD, Clinic of Endocrinology and Metabolic Diseases🌐 Sofia, Bulgaria
Sydvestjysk Sygehus Esbjerg - Medicinsk Endokrinologisk Ambulatorium, Forskningsenheden🇩🇰 Esbjerg, Region Syddanmark, Denmark
Sjællands Universitetshospital, Køge - Medicinsk Afdeling🇩🇰 Køge, Region Sjælland, 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
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
Diabetologikum - Diabetologische Schwerpunktpraxis Dr. Thomas Segiet🇩🇪 Speyer, LÄK Rheinland-Pfalz, Germany
A.O.Universitaria S.ORSOLA-MALPIGHI - U.O.Endocrinologia e Cura🇮🇹 Bologna, Italy
Arcispedale Sant'Anna (Cona) - UO di Endocrinologia🇮🇹 Ferrara, Emilia-Romagna, Italy
IRCCS Ospedale Policlinico San Martino - Medicina Interna e Specialità Mediche🇮🇹 Genoa, Liguria, Italy
Azienda Ospedaliera di Padova - UOSD Chirurgia Bariatrica🇮🇹 Padova, Veneto, Italy
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone - Presidio Villa Belmonte🇮🇹 Palermo, Sicily, Italy