Weekly NNC0487-0111 injections for weight loss and knee pain in adults with excess weight and knee osteoarthritis
Efficacy and Safety of NNC0487-0111 s.c. Once-weekly in Participants With Overweight or Obesity, and Knee Osteoarthritis (AMAZE 5)
This will try weekly NNC0487-0111 injections versus placebo to see if adults with excess body weight and knee osteoarthritis can lose weight and have less knee pain.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Novo Nordisk A/S Industry-sponsored |
| Locations | 82 sites (Phoenix, Arizona and 81 other locations) |
| Trial ID | NCT07481630 on ClinicalTrials.gov |
What this trial studies
This Phase 3, randomized, placebo-controlled study gives adults with excess body weight and symptomatic knee osteoarthritis weekly subcutaneous injections of either NNC0487-0111 or a matched placebo. Eligible participants must have radiographic knee OA in the target knee (Kellgren-Lawrence grade 2–3) and a history of persistent knee pain meeting the study’s timing requirements. Treatments are assigned by chance and participants complete scheduled visits and symptom questionnaires, including WOMAC, with specified analgesic washout before those assessments. The trial is sponsored by Novo Nordisk and is being run at several U.S. clinical research sites.
Who should consider this trial
Good fit: Adults 18 and older with excess body weight, symptomatic knee osteoarthritis (KL grade 2–3 in the target knee), and the specified recent pain history who can comply with study visits and analgesic washout are ideal candidates.
Not a fit: People without excess body weight, with very severe (KL grade 4) knee OA, or with uncontrolled blood sugar (HbA1c ≥6.5%) or other exclusionary conditions are unlikely to be eligible or to benefit.
Why it matters
Potential benefit: If successful, it could help patients lose weight and reduce knee pain, improving mobility and quality of life.
How similar studies have performed: Other weight-loss medications have produced substantial weight reduction and sometimes improved joint pain, but NNC0487-0111 itself is a newer agent now being tested in Phase 3.
Eligibility criteria
Show full inclusion / exclusion criteria
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 (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 this trial is running
Phoenix, Arizona and 81 other locations
- Arizona Research Center, Inc. — Phoenix, Arizona, United States (Not_yet_recruiting)
- Diablo Clinical Research, Inc. — Walnut Creek, California, United States (Not_yet_recruiting)
- Chase Medical Research LLC — Hamden, Connecticut, United States (Not_yet_recruiting)
- Chase Medical Research LLC — Waterbury, Connecticut, United States (Not_yet_recruiting)
- Zenith clinical research — Hollywood, Florida, United States (Not_yet_recruiting)
- CNS Healthcare — Jacksonville, Florida, United States (Not_yet_recruiting)
- Angels Clinical Research Institute — Miami Lakes, Florida, United States (Not_yet_recruiting)
- Hope Clin Res & Wellness — Conyers, Georgia, United States (Not_yet_recruiting)
- CenExel iResearch, LLC — Decatur, Georgia, United States (Not_yet_recruiting)
- Elite Clinical Trials — Blackfoot, Idaho, United States (Not_yet_recruiting)
- MedVadis Research Watertown — Waltham, Massachusetts, United States (Not_yet_recruiting)
- Jubilee Clinical Research, Inc. — Las Vegas, Nevada, United States (Not_yet_recruiting)
- Great Lakes Medical Research — Westfield, New York, United States (Not_yet_recruiting)
- Accellacare and KDCILM, LLC — Wilmington, North Carolina, United States (Not_yet_recruiting)
- Coastal Carolina Res Ctr — North Charleston, South Carolina, United States (Not_yet_recruiting)
- VIP Trials_San Antonio — San Antonio, Texas, United States (Not_yet_recruiting)
- Charlottesville Med Research — Charlottesville, Virginia, United States (Not_yet_recruiting)
- Health Res of Hampton Roads — Newport News, Virginia, United States (Not_yet_recruiting)
- Northwest Clinical Research Center — Bellevue, Washington, United States (Not_yet_recruiting)
- Emeritus Research Sydney — Botany, New South Wales, Australia (Recruiting)
- Momentum Clinical Research Darlinghurst — Darlinghurst, New South Wales, Australia (Recruiting)
- Kolling Institute — St Leonards, New South Wales, Australia (Not_yet_recruiting)
- Heart of Australia — Chelmer, Queensland, Australia (Not_yet_recruiting)
- Coastal Digestive Health — Maroochydore, Queensland, Australia (Not_yet_recruiting)
- UMHAT Sveti Georgi EAD, Plovdiv — Plovdiv, Bulgaria (Recruiting)
- MC Dr. Atanasov EOOD — Sofia, Bulgaria (Recruiting)
- MC Excelsior OOD — Sofia, Bulgaria (Recruiting)
- UMHAT Tsaritsa Yoanna - ISUL EAD, Orthopaedics and Traumatology — Sofia, Bulgaria (Recruiting)
- MMA MHAT - Sofia, Rheumatology clinic — Sofia, Bulgaria (Recruiting)
- UMHAT Sveti Ivan Rilski EAD, Rheumatology — Sofia, Bulgaria (Not_yet_recruiting)
- Laser Rejuvenation Clinics Inc. — Calgary, Alberta, Canada (Not_yet_recruiting)
- Dawson Clinical Research — Guelph, Ontario, Canada (Not_yet_recruiting)
- Hamilton Medical Rsrch Grp — Hamilton, Ontario, Canada (Not_yet_recruiting)
- Centre de Recherche Musculo — Trois-Rivières, Quebec, Canada (Recruiting)
- Alpha Recherche Clinique - Lebourgneuf — Québec, Canada (Recruiting)
- Aarhus Universitetshospital - Klinik for Led og bindevævssygdomme — Aarhus N, Denmark (Recruiting)
- Frederiksberg Hospital - Parker Institutet (Artrose) — Frederiksberg, Denmark (Recruiting)
- Sanos Clinic - Herlev — Herlev, Denmark (Recruiting)
- University General Hospital Attikon General Hospital Of West Attica H Agia Varvara - 2nd dept of Internal medicine — Chaïdári, Attica, Greece (Not_yet_recruiting)
- Laiko General Hospital Of Athens - 1st department of Internal Medicine — Athens, Greece (Not_yet_recruiting)
- Athens Medical Center S.A. (Iatriko Psychicou) - Department of Internal Medicine & Metabolic Diseases — Athens, Greece (Not_yet_recruiting)
- General Hospital Of Athens Alexandra - Clinical Therapeutics — Athens, Greece (Not_yet_recruiting)
- Athens Medical Center S.A. (Iatriko Athinon) - Diabetes and Obesity Unit — Marousi, Greece (Not_yet_recruiting)
- NextHealth S.A. - Department of Endocrinology, Metabolism & Diabetes — Thessaloniki, Greece (Not_yet_recruiting)
- Thermi Clinic S.A. - Diabetes and Internal Medicine Department — Thessaloniki, Greece (Not_yet_recruiting)
- AOU Federico II Di Napoli - DAI Endocr. Diab. Andro. e Nutr. - UOC Medicina Interna e Nutrizione Clinica — Naples, Campania, Italy (Not_yet_recruiting)
- Ospedale Civile di Baggiovara - UOC Endocrinologia — Modena, Emilia-Romagna, Italy (Not_yet_recruiting)
- Ospedale S. Maria della Misericordia - Reparto Endocrinologia e Malattie del Metabolismo — Udine, Friuli Venezia Giulia, Italy (Not_yet_recruiting)
- Pol. Uni. Campus Biomedico - UOC Endocrinologia e Diabetologia — Rome, Lazio, Italy (Not_yet_recruiting)
- Auxologico San Luca - Endocrinologia e Malattie del Metabolismo — Milan, Lombardy, Italy (Not_yet_recruiting)
+32 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Novo Nordisk
- Email: clinicaltrials@novonordisk.com
- Phone: (+1) 866-867-7178
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.