Actively Recruiting
Efficacy and Safety of NNC0487-0111 Subcutaneous Once-Weekly in Adults With Overweight or Obesity and Knee Osteoarthritis (AMAZE 6)
Led by Novo Nordisk A/S · Updated on 2026-06-02
400
Participants Needed
81
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effects of NNC0487-0111 in people who have excess body weight and knee osteoarthritis. This study compares NNC0487-0111 with a placebo to see how well the treatment helps with weight loss and pain reduction. It is a phase 3 study sponsored by Novo Nordisk A/S. Participants have clinical and radiographic evidence of knee osteoarthritis and experience knee pain. Participants are randomly assigned to receive one of two dose levels of NNC0487-0111 or a matching placebo. Both treatments are given as injections under the skin once a week using pre-filled pen injectors. All participants follow a reduced-calorie diet and increase their physical activity during the study. The treatment period lasts up to 80 weeks. During the study, participants will have regular assessments of body weight, knee pain using the WOMAC pain score, physical function, stiffness, and quality of life through surveys. Blood tests will measure cholesterol, blood sugar, and inflammation markers. Researchers will also monitor use of pain medications and any side effects up to week 84. The total time participants may be involved is about 80 weeks, with ongoing safety monitoring throughout the study.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female (sex at birth)
- Age 18 years or older at the time of signing consent
- Clinical diagnosis of knee osteoarthritis with radiographic changes (Kellgren Lawrence grades 2 to 4)
- Target knee is most symptomatic or dominant leg if equal pain
- Symptomatic knee OA with pain in the target knee for more than 90 days before screening
- Pain in target knee for more than 15 days in the prior 30 days
- Willing to complete 72-hour washout of analgesics before visits involving WOMAC questionnaire (acetaminophen up to 4 g/day allowed as rescue medication until 24 hours before visits)
You will not qualify if you...
- Glycated haemoglobin (HbA1c) 6.5% or higher at screening
- History of type 1 or type 2 diabetes mellitus
- Treatment with GLP-1 receptor agonists, dual GLP-1/GIP receptor agonists, or amylin analogues before screening
- Any joint prosthesis or joint replacement in the target knee
- Arthroscopy or injections into the target knee within 90 days before screening
- Any other joint disease in the target knee such as gout or pseudogout
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 80 weeks
Participants receive NNC0487-0111 or placebo subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity to help with weight loss and knee osteoarthritis pain reduction.
Weekly visits for up to 80 weeks
Duration - 4 weeks
Participants are monitored for any treatment emergent adverse events and overall safety after the treatment period ends.
Visits occurring up to week 84
Trial Site Locations
Total: 81 locations
1
Neighborhood Healthcare
Escondido, California, United States, 92025
Actively Recruiting
2
First Valley Medical Group
Lancaster, California, United States, 93534
Actively Recruiting
3
Desert Oasis Healthcare
Palm Springs, California, United States, 92262
Actively Recruiting
4
Chase Medical Research LLC
Waterbury, Connecticut, United States, 06708
Actively Recruiting
5
Westside Center For Clinical Research
Jacksonville, Florida, United States, 32205
Actively Recruiting
6
CNS Healthcare
Jacksonville, Florida, United States, 32256
Actively Recruiting
7
Advanced Res for Health Improve
Naples, Florida, United States, 34102
Actively Recruiting
8
Clinical Investigation Spec Gurnee
Gurnee, Illinois, United States, 60031
Actively Recruiting
9
Evanston Premier Hlthcr Res
Skokie, Illinois, United States, 60077
Actively Recruiting
10
Monroe Biomedical Research, LLC
Louisville, Kentucky, United States, 40213
Actively Recruiting
11
Arcturus Healthcare, PLC.
Troy, Michigan, United States, 48098-6368
Actively Recruiting
12
Clinvest Research
Springfield, Missouri, United States, 65807
Actively Recruiting
13
NYU Langone Orthopedic Center
New York, New York, United States, 10016
Not Yet Recruiting
14
Hospital For Special Surgery
New York, New York, United States, 10021
Not Yet Recruiting
15
Piedmont Healthcare/Research
Statesville, North Carolina, United States, 28625
Actively Recruiting
16
Northwest Research Center
Portland, Oregon, United States, 97202
Actively Recruiting
17
Mercy Family Clinic
Dallas, Texas, United States, 75208
Not Yet Recruiting
18
Health Res of Hampton Roads
Newport News, Virginia, United States, 23606
Actively Recruiting
19
Northwest Clinical Research Center
Bellevue, Washington, United States, 98007
Actively Recruiting
20
Emeritus Research Sydney
Botany, New South Wales, Australia, 2019
Actively Recruiting
21
Momentum Clinical Research Darlinghurst
Darlinghurst, New South Wales, Australia, 2010
Actively Recruiting
22
Kolling Institute
St Leonards, New South Wales, Australia, 2065
Actively Recruiting
23
Heart of Australia
Chelmer, Queensland, Australia, 4068
Actively Recruiting
24
Coastal Digestive Health
Maroochydore, Queensland, Australia, 4558
Actively Recruiting
25
UMHAT Sveti Georgi EAD, Plovdiv
Plovdiv, Bulgaria, 4002
Actively Recruiting
26
MC Dr. Atanasov EOOD
Sofia, Bulgaria, 1231
Actively Recruiting
27
MC Excelsior OOD
Sofia, Bulgaria, 1407
Actively Recruiting
28
UMHAT Tsaritsa Yoanna - ISUL EAD, Orthopaedics and Traumatology
Sofia, Bulgaria, 1527
Actively Recruiting
29
MMA MHAT - Sofia, Rheumatology clinic
Sofia, Bulgaria, 1606
Actively Recruiting
30
UMHAT Sveti Ivan Rilski EAD, Rheumatology
Sofia, Bulgaria, 1612
Actively Recruiting
31
TLC Diabetes and Endocrinology
Surrey, British Columbia, Canada, V3T 2V6
Not Yet Recruiting
32
Your Research Network
Niagara Falls, Ontario, Canada, L2H 1H5
Actively Recruiting
33
ALPHA Recherche Clinique
Lévis, Quebec, Canada, G6V 0C9
Actively Recruiting
34
Centre Medical Acadie
Montreal, Quebec, Canada, H4N 2W2
Actively Recruiting
35
ALPHA Recherche Clinique
Québec, Quebec, Canada, G3K 2P8
Actively Recruiting
36
Centre de Recherche du CHUS
Sherbrooke, Quebec, Canada, J1H 5N4
Actively Recruiting
37
Aarhus Universitetshospital - Klinik for Led og bindevævssygdomme
Aarhus N, Denmark, 8200
Actively Recruiting
38
Frederiksberg Hospital - Parker Institutet (Artrose)
Frederiksberg, Denmark, 2000
Actively Recruiting
39
Sanos Clinic - Herlev
Herlev, Denmark, 2730
Actively Recruiting
40
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara - 2nd dept of Internal medicine
Chaïdári, Attica, Greece, 12461
Actively Recruiting
41
Evangelismos S.A. - Endocrinology department
Athens, Greece, 10676
Actively Recruiting
42
Laiko General Hospital Of Athens - 1st department of Internal Medicine
Athens, Greece, 115 27
Actively Recruiting
43
Athens Medical Center S.A. (Iatriko Psychicou) - Department of Internal Medicine & Metabolic Diseases
Athens, Greece, 11525
Actively Recruiting
44
Athens Medical Center S.A. (Iatriko Athinon) - Diabetes and Obesity Unit
Marousi, Greece, 15125
Actively Recruiting
45
NextHealth S.A. - Department of Endocrinology, Metabolism & Diabetes
Thessaloniki, Greece, 54635
Actively Recruiting
46
Thermi Clinic S.A. - Diabetes and Internal Medicine Department
Thessaloniki, Greece, 57001
Actively Recruiting
47
Ospedale S. Maria della Misericordia - Reparto Endocrinologia e Malattie del Metabolismo
Udine, Friuli Venezia Giulia, Italy, 33100
Not Yet Recruiting
48
Casa della Salute di Ceccano - Ambulatori Campus Biomedico
Rome, Lazio, Italy, 00128
Not Yet Recruiting
49
Pol. Uni. Campus Biomedico - UOC Endocrinologia e Diabetologia
Rome, Lazio, Italy, 00128
Not Yet Recruiting
50
Auxologico San Luca - Endocrinologia e Malattie del Metabolismo
Milan, Lombardy, Italy, 20149
Not Yet Recruiting
51
Ospedale Galeazzi S.p.A. - INCO - Istituto Nazionale per la Cura dell'Obesità
Milan, Lombardy, Italy, 20157
Not Yet Recruiting
52
Policlinico San Donato di Milano S.p.A - UOS Endocrinologia e del Servizio di Nutrizione Clinica e Prevenzione Cardiometabolica
San Donato Milanese, Lombardy, Italy, 20097
Not Yet Recruiting
53
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Civile Maggiore Borgo Trento - U.O. Reumatologia
Verona, Veneto, Italy, 37126
Not Yet Recruiting
54
"Zdrowie Osteo-Medic" s.c. Lidia i Artur Racewicz, Agnieszka i Jerzy Supronik
Bialystok, Podlaskie Voivodeship, Poland, 15-351
Actively Recruiting
55
ClinicMed Daniluk, Nowak Spółka Komandytowa
Bialystok, Poland, 15-879
Actively Recruiting
56
Centrum Medyczne Intercor Sp. z o.o.
Bydgoszcz, Poland, 85-605
Actively Recruiting
57
Centrum Medyczne Intercor Sp. z o.o.
Bydgoszcz, Poland, 85-605
Not Yet Recruiting
58
CenterMed Kraków Sp. z o.o.
Krakow, Poland, 31-530
Actively Recruiting
59
CenterMed Kraków Sp. z o.o.
Krakow, Poland, 31-530
Not Yet Recruiting
60
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie Sp. z o.o.
Krakow, Poland, 31-826
Actively Recruiting
61
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie Sp. z o.o.
Krakow, Poland, 31-826
Not Yet Recruiting
62
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. prof. dr hab. med. Eleonory Reicher
Warsaw, Poland, 02-637
Actively Recruiting
63
Latin Clinical Trial Center Puerto Rico
San Juan, Puerto Rico, 00909
Actively Recruiting
64
Instituto Medico Quirurgico San Rafael
A Coruña, Spain, 15006
Not Yet Recruiting
65
Hospital Germans Trias i Pujol
Badalona, Spain, 08916
Not Yet Recruiting
66
Hospital Naval Ferrol
Ferrol, Spain, 15405
Actively Recruiting
67
Centro Especialidades Hermanos Sangro
Madrid, Spain, 28038
Not Yet Recruiting
68
Hospital Quirónsalud Málaga
Málaga, Spain, 29004
Actively Recruiting
69
Hospital Infanta Sofía
San Sebastián de Los Reyes (Madrid), Spain, 28702
Actively Recruiting
70
Hospital Universitario Marqués de Valdecilla
Santander, Spain, 39008
Actively Recruiting
71
Hospital HM La Esperanza
Santiago de Compostela, Spain, 15705
Actively Recruiting
72
Clínica Nuevas Tecnologías en Diabetes y Endocrinología
Seville, Spain, 41003
Actively Recruiting
73
H. Infanta Luisa_Endocrino y Obesidad
Seville, Spain, 41010
Actively Recruiting
74
Hospital General de Valencia
Valencia, Spain, 46014
Actively Recruiting
75
İstanbul Fizik Tedavi ve Rehabilitasyon Eğitim ve Araştırma Hastanesi
Bahçelievler/İstanbul, Turkey (Türkiye), 34186
Actively Recruiting
76
Ankara Bilkent Şehir Hastanesi- Fizik Tedavi ve Rehabilitasyon
Çankaya/Ankara, Turkey (Türkiye), 06800
Actively Recruiting
77
SBÜ Ankara Gaziler Fizik Tedavi Ve Rehabilitasyon Eğitim Ve Araştırma Hastanesi
Çankaya/Ankara, Turkey (Türkiye), 06800
Actively Recruiting
78
Trakya Üniversitesi Tıp Fakültesi Hastanesi-Fizik Tedavi ve Rehabilitasyon
Edirne, Turkey (Türkiye), 22030
Actively Recruiting
79
Istanbul Üniversitesi- Istanbul Tıp Fakültesi Esnaf Hastanesi Poliklinikleri Fiziksel Tıp Ve Rehabilitasyon Anabilim Dalı
Fatih/İstanbul, Turkey (Türkiye), 34116
Actively Recruiting
80
Adana Şehir Eğitim ve Araştırma Hastanesi-Fizik Tedavi ve Rehabilitasyon
Yuregir/Adana, Turkey (Türkiye), 01060
Actively Recruiting
81
Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi-Fizik Tedavi ve Rehabilitasyon
Yıldırım/Bursa, Turkey (Türkiye), 16310
Actively Recruiting
Research Team
N
Novo Nordisk
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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