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
Key facts
- Where
- Lévis, Montreal, Niagara Falls, Québec, Sherbrooke, and Surrey, CanadaSee the 6 sites
- Phase
- Phase 3
Where in Canada
- ALPHA Recherche CliniqueLévis, CanadaTaking people
- Centre Medical AcadieMontreal, CanadaTaking people
- Your Research NetworkNiagara Falls, CanadaTaking people
- Alpha Recherche CliniqueQuébec, CanadaTaking people
- Centre de recherche du CHUSSherbrooke, CanadaTaking people
- TLC Diabetes and EndocrinologySurrey, CanadaNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Novo Nordisk A/S
- Trial code
- NCT07509307EU 2024-520445-23-00
- Record updated
- 17 August 2026
- Original description
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.Read full original descriptionShow less
Efficacy and Safety of NNC0487-0111 s.c. Once-weekly in Participants With Overweight or Obesity, and Knee Osteoarthritis (AMAZE 6)
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.
Inclusion: 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).
Exclusion: 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; Arthroscopy or injections into target knee within the last 90 days prior to screening; History of type 1 or type 2 diabetes mellitus as declared by the participant or reported in the medical records; Any other joint disease in target knee including gout and pseudogout; Glycated haemoglobin (HbA1c) ≥ 6.5% (48 mmol/mol) as measured by the central laboratory at screening; Any joint prosthesis or joint replacement in target knee.