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
Recruiting · NCT07509307 · 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
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.
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 (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
Where it is running
60 locations listed across 13 US states.
- Neighborhood Healthcare - Escondido, California, United States
- First Valley Medical Group - Lancaster, California, United States
- Desert Oasis Healthcare - Palm Springs, California, United States
- Chase Medical Research LLC - Waterbury, Connecticut, United States
- Westside Center For Clinical Research - Jacksonville, Florida, United States
- Clinical Neuroscience Solutions, LLC - Jacksonville, Florida, United States
- Advanced Res for Health Improve - Naples, Florida, United States
- Clinical Investigation Spec Gurnee - Gurnee, Illinois, United States
- Evanston Premier Hlthcr Res - Skokie, Illinois, United States
- Monroe Biomedical Research, LLC - Louisville, Kentucky, United States
- Arcturus Healthcare, PLC. - Troy, Michigan, United States
- Clinvest Research - Springfield, Missouri, United States
- NYU Langone Orthopedic Center - New York, New York, United States
- Hospital For Special Surgery - New York, New York, United States
- Piedmont Healthcare/Research - Statesville, North Carolina, United States
- Northwest Research Center - Portland, Oregon, United States
- Mercy Family Clinic - Dallas, Texas, 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
- Evangelismos S.A. - Endocrinology department - Athens, Greece
- 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
- 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
- Centrum Medyczne Intercor Sp. z o.o. - Bydgoszcz, Poland
- Centrum Medyczne Intercor Sp. z o.o. - Bydgoszcz, Poland
- Trakya Üniversitesi Tıp Fakültesi Hastanesi-Fizik Tedavi ve Rehabilitasyon - Edirne, Turkey (Türkiye)
- Istanbul Üniversitesi- Istanbul Tıp Fakültesi Esnaf Hastanesi Poliklinikleri Fiziksel Tıp Ve Rehabilitasyon Anabilim Dalı - Fatih/İstanbul, Turkey (Türkiye)
- Hospital Naval Ferrol - Ferrol, Spain
- Frederiksberg Hospital - Parker Institutet (Artrose) - Frederiksberg, Denmark
- Sanos Clinic - Herlev - Herlev, Denmark
- 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
- Hospital Quirónsalud Málaga - Málaga, Spain
- UMHAT Sveti Georgi EAD, Plovdiv - Plovdiv, Bulgaria
- Latin Clinical Trial Center Puerto Rico - San Juan, Puerto Rico
- 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
- Hospital General de Valencia - Valencia, Spain
- Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. prof. dr hab. med. Eleonory Reicher - Warsaw, Poland
- Adana Şehir Eğitim ve Araştırma Hastanesi-Fizik Tedavi ve Rehabilitasyon - Yuregir/Adana, Turkey (Türkiye)
- Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi-Fizik Tedavi ve Rehabilitasyon - Yıldırım/Bursa, Turkey (Türkiye)
- Ankara Bilkent Şehir Hastanesi- Fizik Tedavi ve Rehabilitasyon - Çankaya/Ankara, Turkey (Türkiye)
Showing 60 of 81 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →