A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Knee Osteoarthritis Lose Weight and Reduce Pain
Recruiting · NCT07481630 · Interventional (participants receive a specific treatment) · Lead sponsor: Novo Nordisk A/S
View the official record on ClinicalTrials.gov →Interventions studied
NNC0487-0111Placebo (matched to NNC0487-0111 )
What this trial 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 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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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 (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).
Exclusion criteria
- Glycated haemoglobin more 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.
- 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.
Where it is running
60 locations listed across 14 US states.
- Arizona Research Center, Inc. - Phoenix, Arizona, United States
- Diablo Clinical Research, Inc. - Walnut Creek, California, United States
- Chase Medical Research LLC - Hamden, Connecticut, United States
- Chase Medical Research LLC - Waterbury, Connecticut, United States
- Zenith clinical research - Hollywood, Florida, United States
- CNS Healthcare - Jacksonville, Florida, United States
- Angels Clinical Research Institute - Miami Lakes, Florida, United States
- Hope Clin Res & Wellness - Conyers, Georgia, United States
- CenExel iResearch, LLC - Decatur, Georgia, United States
- Elite Clinical Trials - Blackfoot, Idaho, United States
- MedVadis Research Watertown - Waltham, Massachusetts, United States
- Jubilee Clinical Research, Inc. - Las Vegas, Nevada, United States
- Great Lakes Medical Research - Westfield, New York, United States
- Accellacare and KDCILM, LLC - Wilmington, North Carolina, United States
- Coastal Carolina Res Ctr - North Charleston, South Carolina, United States
- VIP Trials_San Antonio - San Antonio, Texas, United States
- Charlottesville Med Research - Charlottesville, Virginia, United States
- Health Res of Hampton Roads - Newport News, Virginia, United States
- Northwest Clinical Research Center - Bellevue, Washington, United States
- Instituto Medico Quirurgico San Rafael - A Coruña, Spain
- Aarhus Universitetshospital - Klinik for Led og bindevævssygdomme - Aarhus N, Denmark
- Ankara Üniversitesi Sağlık Uygulama ve Araştırma Hastaneleri- Fiziksel Tıp ve Rehabilitasyon - Altındağ/Ankara, Turkey (Türkiye)
- Laiko General Hospital Of Athens - 1st department of Internal Medicine - Athens, Greece
- Athens Medical Center S.A. (Iatriko Psychikou) - Department of Internal Medicine & Metabolic Diseases - Athens, Greece
- General Hospital Of Athens Alexandra - Clinical Therapeutics - Athens, Greece
- Hospital Germans Trias i Pujol - Badalona, Spain
- İstanbul Fizik Tedavi ve Rehabilitasyon Eğitim ve Araştırma Hastanesi - Bahçelievler/İstanbul, Turkey (Türkiye)
- ClinicMed Daniluk, Nowak Spółka Komandytowa - Bialystok, Poland
- ClinicMed Daniluk, Nowak Spółka Komandytowa - Bialystok, Poland
- Centrum Medyczne Intercor Sp. z o.o. - Bydgoszcz, Poland
- Centrum Medyczne Intercor Sp. z o.o. - Bydgoszcz, Poland
- Hospital Naval Ferrol - Ferrol, Spain
- Frederiksberg Hospital - Parker Institutet (Artrose) - Frederiksberg, Denmark
- Sanos Clinic - Herlev - Herlev, Denmark
- Çanakkale Onsekiz Mart Üniversitesi Sağlık Araştırma ve Uygulama Hastanesi-Fiziksel Tıp ve Rehabilitasyon - Kepez/Çanakkale Merkez/Çanakkale, Turkey (Türkiye)
- CenterMed Kraków Sp. z o.o. - Krakow, Poland
- CenterMed Kraków Sp. z o.o. - Krakow, Poland
- Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie Sp. z o.o. - Krakow, Poland
- Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie Sp. z o.o. - Krakow, Poland
- Centro Especialidades Hermanos Sangro - Madrid, Spain
- Athens Medical Center S.A. (Iatriko Athinon) - Diabetes and Obesity Unit - Marousi, Greece
- İnönü Üniversitesi Turgut Özal Tıp Merkezi Hastanesi-Fiziksel Tıp ve Rehabilitasyon - Merkez/Battalgazi/Malatya, Turkey (Türkiye)
- Hospital Quirónsalud Málaga - Málaga, Spain
- UMHAT Sveti Georgi EAD, Plovdiv - Plovdiv, Bulgaria
- Alpha Recherche Clinique - Lebourgneuf - Québec, Canada
- Hospital Infanta Sofía - San Sebastián de Los Reyes (Madrid), Spain
- Hospital Universitario Marqués de Valdecilla - Santander, Spain
- Hospital HM La Esperanza - Santiago de Compostela, Spain
- Clínica Nuevas Tecnologías en Diabetes y Endocrinología - Seville, Spain
- H. Infanta Luisa_Endocrino y Obesidad - Seville, Spain
- MC Dr. Atanasov EOOD - Sofia, Bulgaria
- MC Excelsior OOD - Sofia, Bulgaria
- UMHAT Tsaritsa Yoanna - ISUL EAD, Orthopaedics and Traumatology - Sofia, Bulgaria
- MMA MHAT - Sofia, Rheumatology clinic - Sofia, Bulgaria
- UMHAT Sveti Ivan Rilski EAD, Rheumatology - Sofia, Bulgaria
- NextHealth S.A. - Department of Endocrinology, Metabolism & Diabetes - Thessaloniki, Greece
- Thermi Clinic S.A. - Diabetes and Internal Medicine Department - Thessaloniki, Greece
- Karadeniz Teknik Üniversitesi Farabi Hastanesi- Fiziksel Tıp ve Rehabilitasyon - Trabzon Merkez/Ortahisar/Trabzon, Turkey (Türkiye)
- Hospital General de Valencia - Valencia, Spain
- Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. prof. dr hab. med. Eleonory Reicher - Warsaw, Poland
Showing 60 of 82 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →