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NCT07509307PHASE3Recruiting

AMAZE 6: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Knee Osteoarthritis Lose Weight and Reduce Pain

Novo Nordisk A/S

Start Date

4/20/2026

Completion Date

8/14/2028

Summary

This study is being done to look at the safety and effect of NNC0487-0111 in people with excess body weight and knee osteoarthritis when compared to placebo. 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 Criteria

Age Range: 18 years to No maximum

Key Inclusion Criteria: * Male or female (sex at birth) * Age 18 years or above at the time of signing the informed consent * Clinical diagnosis of knee osteoarthritis (OA) (American College of Rheumatology criteria) with radiographic changes (Kellgren Lawrence \[KL\] grades 2 to 4 as per central reading) in target knee. Target knee joint is defined as most symptomatic knee at screening. If pain in knees is equal, the target knee joint will be the dominant leg * Symptomatic knee OA with first appearance of pain in the target knee \> 90 days prior to screening and pain in the target knee for \> 15 days over the prior 30 days * Willingness to complete a 72-hour washout period of analgesics before all visits involving WOMAC Osteoarthritis Index NRS 3.1 (24-hour) (WOMAC) questionnaire (acetaminophen 4 grams (g)/day is allowed as rescue medication up until 24 hours before those visits) Key Exclusion Criteria: * Glycated haemoglobin (HbA1c) ≥ 6.5% (48 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 * Any joint prosthesis or joint replacement in target knee * Arthroscopy or injections into target knee within the last 90 days prior to screening * Any other joint disease in target knee including gout and pseudogout

Interventions

DRUG

NNC0487-0111

DRUG

Placebo (matched to NNC0487-0111)

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

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Conditions

ObesityOverweightOsteoarthritis, Knee

Locations

Neighborhood Healthcare

Escondido, California 92025

United States

First Valley Medical Group

Lancaster, California 93534

United States

Desert Oasis Healthcare

Palm Springs, California 92262

United States

Chase Medical Research LLC

Waterbury, Connecticut 06708

United States

Westside Center For Clinical Research

Jacksonville, Florida 32205

United States

CNS Healthcare

Jacksonville, Florida 32256

United States

Advanced Res for Health Improve

Naples, Florida 34102

United States

Clinical Investigation Spec Gurnee

Gurnee, Illinois 60031

United States

Evanston Premier Hlthcr Res

Skokie, Illinois 60077

United States

Monroe Biomedical Research, LLC

Louisville, Kentucky 40213

United States

Arcturus Healthcare, PLC.

Troy, Michigan 48098-6368

United States

Clinvest Research

Springfield, Missouri 65807

United States

NYU Langone Orthopedic Center

New York, New York 10016

United States

Hospital For Special Surgery

New York, New York 10021

United States

Piedmont Healthcare/Research

Statesville, North Carolina 28625

United States

Northwest Research Center

Portland, Oregon 97202

United States

Mercy Family Clinic

Dallas, Texas 75208

United States

Health Res of Hampton Roads

Newport News, Virginia 23606

United States

Northwest Clinical Research Center

Bellevue, Washington 98007

United States

Emeritus Research Sydney

Botany, New South Wales 2019

Australia

Momentum Clinical Research Darlinghurst

Darlinghurst, New South Wales 2010

Australia

Kolling Institute

St Leonards, New South Wales 2065

Australia

Heart of Australia

Chelmer, Queensland 4068

Australia

Coastal Digestive Health

Maroochydore, Queensland 4558

Australia

UMHAT Sveti Georgi EAD, Plovdiv

Plovdiv, 4002

Bulgaria

MC Dr. Atanasov EOOD

Sofia, 1231

Bulgaria

MC Excelsior OOD

Sofia, 1407

Bulgaria

UMHAT Tsaritsa Yoanna - ISUL EAD, Orthopaedics and Traumatology

Sofia, 1527

Bulgaria

MMA MHAT - Sofia, Rheumatology clinic

Sofia, 1606

Bulgaria

UMHAT Sveti Ivan Rilski EAD, Rheumatology

Sofia, 1612

Bulgaria

TLC Diabetes and Endocrinology

Surrey, British Columbia V3T 2V6

Canada

Your Research Network

Niagara Falls, Ontario L2H 1H5

Canada

ALPHA Recherche Clinique

Lévis, Quebec G6V 0C9

Canada

Centre Medical Acadie

Montreal, Quebec H4N 2W2

Canada

ALPHA Recherche Clinique

Québec, Quebec G3K 2P8

Canada

Centre de Recherche du CHUS

Sherbrooke, Quebec J1H 5N4

Canada

Aarhus Universitetshospital - Klinik for Led og bindevævssygdomme

Aarhus N, 8200

Denmark

Frederiksberg Hospital - Parker Institutet (Artrose)

Frederiksberg, 2000

Denmark

Sanos Clinic - Herlev

Herlev, 2730

Denmark

University General Hospital Attikon General Hospital Of West Attica H Agia Varvara - 2nd dept of Internal medicine

Chaïdári, Attica 12461

Greece

Evangelismos S.A. - Endocrinology department

Athens, 10676

Greece

Laiko General Hospital Of Athens - 1st department of Internal Medicine

Athens, 115 27

Greece

Athens Medical Center S.A. (Iatriko Psychicou) - Department of Internal Medicine & Metabolic Diseases

Athens, 11525

Greece

Athens Medical Center S.A. (Iatriko Athinon) - Diabetes and Obesity Unit

Marousi, 15125

Greece

NextHealth S.A. - Department of Endocrinology, Metabolism & Diabetes

Thessaloniki, 54635

Greece

Thermi Clinic S.A. - Diabetes and Internal Medicine Department

Thessaloniki, 57001

Greece

Ospedale S. Maria della Misericordia - Reparto Endocrinologia e Malattie del Metabolismo

Udine, Friuli Venezia Giulia 33100

Italy

Casa della Salute di Ceccano - Ambulatori Campus Biomedico

Rome, Lazio 00128

Italy

Pol. Uni. Campus Biomedico - UOC Endocrinologia e Diabetologia

Rome, Lazio 00128

Italy

Auxologico San Luca - Endocrinologia e Malattie del Metabolismo

Milan, Lombardy 20149

Italy

Ospedale Galeazzi S.p.A. - INCO - Istituto Nazionale per la Cura dell'Obesità

Milan, Lombardy 20157

Italy

Policlinico San Donato di Milano S.p.A - UOS Endocrinologia e del Servizio di Nutrizione Clinica e Prevenzione Cardiometabolica

San Donato Milanese, Lombardy 20097

Italy

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

Verona, Veneto 37126

Italy

"Zdrowie Osteo-Medic" s.c. Lidia i Artur Racewicz, Agnieszka i Jerzy Supronik

Bialystok, Podlaskie Voivodeship 15-351

Poland

ClinicMed Daniluk, Nowak Spółka Komandytowa

Bialystok, 15-879

Poland

Centrum Medyczne Intercor Sp. z o.o.

Bydgoszcz, 85-605

Poland

Centrum Medyczne Intercor Sp. z o.o.

Bydgoszcz, 85-605

Poland

CenterMed Kraków Sp. z o.o.

Krakow, 31-530

Poland

CenterMed Kraków Sp. z o.o.

Krakow, 31-530

Poland

Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie Sp. z o.o.

Krakow, 31-826

Poland

Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie Sp. z o.o.

Krakow, 31-826

Poland

Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. prof. dr hab. med. Eleonory Reicher

Warsaw, 02-637

Poland

Latin Clinical Trial Center Puerto Rico

San Juan, 00909

Puerto Rico

Instituto Medico Quirurgico San Rafael

A Coruña, 15006

Spain

Hospital Germans Trias i Pujol

Badalona, 08916

Spain

Hospital Naval Ferrol

Ferrol, 15405

Spain

Centro Especialidades Hermanos Sangro

Madrid, 28038

Spain

Hospital Quirónsalud Málaga

Málaga, 29004

Spain

Hospital Infanta Sofía

San Sebastián de Los Reyes (Madrid), 28702

Spain

Hospital Universitario Marqués de Valdecilla

Santander, 39008

Spain

Hospital HM La Esperanza

Santiago de Compostela, 15705

Spain

Clínica Nuevas Tecnologías en Diabetes y Endocrinología

Seville, 41003

Spain

H. Infanta Luisa_Endocrino y Obesidad

Seville, 41010

Spain

Hospital General de Valencia

Valencia, 46014

Spain

İstanbul Fizik Tedavi ve Rehabilitasyon Eğitim ve Araştırma Hastanesi

Bahçelievler/İstanbul, 34186

Turkey (Türkiye)

Ankara Bilkent Şehir Hastanesi- Fizik Tedavi ve Rehabilitasyon

Çankaya/Ankara, 06800

Turkey (Türkiye)

SBÜ Ankara Gaziler Fizik Tedavi Ve Rehabilitasyon Eğitim Ve Araştırma Hastanesi

Çankaya/Ankara, 06800

Turkey (Türkiye)

Trakya Üniversitesi Tıp Fakültesi Hastanesi-Fizik Tedavi ve Rehabilitasyon

Edirne, 22030

Turkey (Türkiye)

Istanbul Üniversitesi- Istanbul Tıp Fakültesi Esnaf Hastanesi Poliklinikleri Fiziksel Tıp Ve Rehabilitasyon Anabilim Dalı

Fatih/İstanbul, 34116

Turkey (Türkiye)

Adana Şehir Eğitim ve Araştırma Hastanesi-Fizik Tedavi ve Rehabilitasyon

Yuregir/Adana, 01060

Turkey (Türkiye)

Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi-Fizik Tedavi ve Rehabilitasyon

Yıldırım/Bursa, 16310

Turkey (Türkiye)