Efficacy and Safety of NNC0487-0111 s.c. Once-weekly in Participants With Overweight or Obesity, and Knee Osteoarthritis (AMAZE 5)
Status: Recruiting
Location: See all (82) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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 and knee osteoarthritis. 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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Male or female (sex at birth).
• Age 18 years or above at the time of signing the informed consent.
• Clinical diagnosis of knee osteoarthritis (American College of Rheumatology criteria) with radiographic changes (Kellgren Lawrence (KL) grades 2 to 3 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 more than (\>) 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 gram (g)/day is allowed as rescue medication up until 24 hours before those visits).
Locations
United States
Arizona
Arizona Research Center, Inc.
RECRUITING
Phoenix
California
Diablo Clinical Research, Inc.
RECRUITING
Walnut Creek
Connecticut
Chase Medical Research LLC
RECRUITING
Hamden
Chase Medical Research LLC
RECRUITING
Waterbury
Florida
Zenith clinical research
RECRUITING
Hollywood
CNS Healthcare
RECRUITING
Jacksonville
Angels Clinical Research Institute
RECRUITING
Miami Lakes
Georgia
Hope Clin Res & Wellness
RECRUITING
Conyers
CenExel iResearch, LLC
RECRUITING
Decatur
Idaho
Elite Clinical Trials
RECRUITING
Blackfoot
Massachusetts
MedVadis Research Watertown
RECRUITING
Waltham
North Carolina
Accellacare and KDCILM, LLC
RECRUITING
Wilmington
Nevada
Jubilee Clinical Research, Inc.
RECRUITING
Las Vegas
New York
Great Lakes Medical Research
RECRUITING
Westfield
South Carolina
Coastal Carolina Res Ctr
RECRUITING
North Charleston
Texas
VIP Trials_San Antonio
RECRUITING
San Antonio
Virginia
Charlottesville Med Research
RECRUITING
Charlottesville
Health Res of Hampton Roads
RECRUITING
Newport News
Washington
Northwest Clinical Research Center
RECRUITING
Bellevue
Other Locations
Australia
Emeritus Research Sydney
RECRUITING
Botany
Heart of Australia
RECRUITING
Chelmer
Momentum Clinical Research Darlinghurst
RECRUITING
Darlinghurst
Coastal Digestive Health
RECRUITING
Maroochydore
Kolling Institute
RECRUITING
St Leonards
Bulgaria
UMHAT Sveti Georgi EAD, Plovdiv
RECRUITING
Plovdiv
MC Dr. Atanasov EOOD
RECRUITING
Sofia
MC Excelsior OOD
RECRUITING
Sofia
MMA MHAT - Sofia, Rheumatology clinic
RECRUITING
Sofia
UMHAT Sveti Ivan Rilski EAD, Rheumatology
RECRUITING
Sofia
UMHAT Tsaritsa Yoanna - ISUL EAD, Orthopaedics and Traumatology
RECRUITING
Sofia
Canada
Laser Rejuvenation Clinics Inc.
NOT_YET_RECRUITING
Calgary
Dawson Clinical Research
RECRUITING
Guelph
Hamilton Medical Rsrch Grp
NOT_YET_RECRUITING
Hamilton
Alpha Recherche Clinique - Lebourgneuf
RECRUITING
Québec
Centre de Recherche Musculo
RECRUITING
Trois-rivières
Denmark
Aarhus Universitetshospital - Klinik for Led og bindevævssygdomme
RECRUITING
Aarhus N
Frederiksberg Hospital - Parker Institutet (Artrose)
RECRUITING
Frederiksberg
Sanos Clinic - Herlev
RECRUITING
Herlev
Greece
Athens Medical Center S.A. (Iatriko Psychicou) - Department of Internal Medicine & Metabolic Diseases
RECRUITING
Athens
General Hospital Of Athens Alexandra - Clinical Therapeutics
RECRUITING
Athens
Laiko General Hospital Of Athens - 1st department of Internal Medicine
RECRUITING
Athens
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara - 2nd dept of Internal medicine
RECRUITING
Chaïdári
Athens Medical Center S.A. (Iatriko Athinon) - Diabetes and Obesity Unit
RECRUITING
Marousi
NextHealth S.A. - Department of Endocrinology, Metabolism & Diabetes
RECRUITING
Thessaloniki
Thermi Clinic S.A. - Diabetes and Internal Medicine Department
RECRUITING
Thessaloniki
Italy
Auxologico San Luca - Endocrinologia e Malattie del Metabolismo
NOT_YET_RECRUITING
Milan
Ospedale Civile di Baggiovara - UOC Endocrinologia
NOT_YET_RECRUITING
Modena
AOU Federico II Di Napoli - DAI Endocr. Diab. Andro. e Nutr. - UOC Medicina Interna e Nutrizione Clinica
NOT_YET_RECRUITING
Naples
Pol. Uni. Campus Biomedico - UOC Endocrinologia e Diabetologia
NOT_YET_RECRUITING
Rome
Policlinico San Donato di Milano S.p.A - UOS Endocrinologia e del Servizio di Nutrizione Clinica e Prevenzione Cardiometabolica
NOT_YET_RECRUITING
San Donato Milanese
Ospedale S. Maria della Misericordia - Reparto Endocrinologia e Malattie del Metabolismo
NOT_YET_RECRUITING
Udine
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Civile Maggiore Borgo Trento - U.O. Reumatologia
NOT_YET_RECRUITING
Verona
Poland
ClinicMed Daniluk, Nowak Spółka Komandytowa
NOT_YET_RECRUITING
Bialystok
ClinicMed Daniluk, Nowak Spółka Komandytowa
RECRUITING
Bialystok
Zdrowie Osteo-Medic s.c. Lidia i Artur Racewicz, Agnieszka i Jerzy Supronik
RECRUITING
Bialystok
Zdrowie Osteo-Medic s.c. Lidia i Artur Racewicz, Agnieszka i Jerzy Supronik
NOT_YET_RECRUITING
Bialystok
Centrum Medyczne Intercor Sp. z o.o.
NOT_YET_RECRUITING
Bydgoszcz
Centrum Medyczne Intercor Sp. z o.o.
RECRUITING
Bydgoszcz
CenterMed Kraków Sp. z o.o.
NOT_YET_RECRUITING
Krakow
CenterMed Kraków Sp. z o.o.
RECRUITING
Krakow
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie Sp. z o.o.
NOT_YET_RECRUITING
Krakow
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie Sp. z o.o.
RECRUITING
Krakow
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. prof. dr hab. med. Eleonory Reicher
RECRUITING
Warsaw
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. prof. dr hab. med. Eleonory Reicher
NOT_YET_RECRUITING
Warsaw
Spain
Instituto Medico Quirurgico San Rafael
RECRUITING
A Coruña
Hospital Germans Trias i Pujol
NOT_YET_RECRUITING
Badalona
Hospital Naval Ferrol
RECRUITING
Ferrol
Centro Especialidades Hermanos Sangro
NOT_YET_RECRUITING
Madrid
Hospital Quirónsalud Málaga
RECRUITING
Málaga
Hospital Infanta Sofía
RECRUITING
San Sebastián De Los Reyes (madrid)
Hospital Universitario Marqués de Valdecilla
RECRUITING
Santander
Hospital HM La Esperanza
RECRUITING
Santiago De Compostela
Clínica Nuevas Tecnologías en Diabetes y Endocrinología
RECRUITING
Seville
H. Infanta Luisa_Endocrino y Obesidad
RECRUITING
Seville
Hospital General de Valencia
RECRUITING
Valencia
Turkey
Ankara Üniversitesi Sağlık Uygulama ve Araştırma Hastaneleri- Fiziksel Tıp ve Rehabilitasyon
RECRUITING
Altındağ/ankara
İstanbul Fizik Tedavi ve Rehabilitasyon Eğitim ve Araştırma Hastanesi
RECRUITING
Bahçelievler/i̇stanbul
Ankara Bilkent Şehir Hastanesi- Fizik Tedavi ve Rehabilitasyon
RECRUITING
Çankaya/ankara
Çanakkale Onsekiz Mart Üniversitesi Sağlık Araştırma ve Uygulama Hastanesi-Fiziksel Tıp ve Rehabilitasyon
NOT_YET_RECRUITING
Kepez/çanakkale Merkez/çanakkale
İnönü Üniversitesi Turgut Özal Tıp Merkezi Hastanesi-Fiziksel Tıp ve Rehabilitasyon
RECRUITING
Merkez/battalgazi/malatya
Karadeniz Teknik Üniversitesi Farabi Hastanesi- Fiziksel Tıp ve Rehabilitasyon
RECRUITING
Trabzon Merkez/ortahisar/trabzon
Adana Şehir Eğitim ve Araştırma Hastanesi-Fizik Tedavi ve Rehabilitasyon
RECRUITING
Yuregir/adana
Contact Information
Primary
Novo Nordisk
clinicaltrials@novonordisk.com
(+1) 866-867-7178
Time Frame
Start Date: 2026-04-13
Estimated Completion Date: 2028-08-14
Participants
Target number of participants: 400
Treatments
Experimental: NNC0487-0111 dose level 1
Participants will be randomized to receive NNC0487-0111 dose level 1 subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.
Experimental: NNC0487-0111 dose level 2
Participants will be randomized to receive NNC0487-0111 dose level 2 subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.
Placebo_comparator: Placebo
Participants will receive placebo matched to NNC0487-0111 subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.
Related Therapeutic Areas
Sponsors
Leads: Novo Nordisk A/S