NNC0487-0111 for weight loss and knee pain in people with overweight and knee osteoarthritis
Tests weekly NNC0487-0111 injections in adults with overweight or obesity and knee osteoarthritis.
Key facts
- Who runs it
- Novo Nordisk A/S
- Where
- Bellevue, Blackfoot, Charlottesville, Conyers, Decatur, Hamden, Hollywood, Jacksonville, Las Vegas, Miami Lakes, Newport News, North Charleston, Phoenix, San Antonio, Walnut Creek, Waltham, Waterbury, Westfield, and Wilmington, United StatesSee the 19 sitesAlso in 9 other countries, 57 sites
- Trial code
- NCT07481630
- EU 2024-520444-42-00
- U1111-1313-6585
- Registry title
- A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Knee Osteoarthritis Lose Weight and Reduce Pain
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 400 people, planned
- Started
- 13 Apr 2026
- Expected to end
- 14 Aug 2028
- Type of study
- Interventional, 3 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- NNC0487-0111
- Placebo (matched to NNC0487-0111 )
- Record updated
- 9 July 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with excess body weight and painful knee osteoarthritis. People get weekly injections of NNC0487-0111 or placebo, chosen by chance.
- Age
- 18 years or older
- Sex
- Women and men (sex at birth)
- Disease stage
- Knee osteoarthritis diagnosed by a doctor, with X-ray changes of Kellgren Lawrence grades 2 to 3 in the target knee. Knee pain for more than 90 days and on more than 15 days in the last 30 days.
- Earlier treatment
- Must not have had GLP-1 receptor agonists, dual GLP-1/GIP receptor agonists or amylin analogues before screening. Must be willing to stop pain medicines for 72 hours before some visits; acetaminophen up to 4 gram/day is allowed until 24 hours before.
- Biomarker or test result
- HbA1c (glycated haemoglobin) below 6.5% (48 mmol/mol) at screening.
Main reasons for not taking part
- HbA1c of 6.5% (48 mmol/mol) or higher at screening
- History of type 1 or type 2 diabetes
- Any joint prosthesis or joint replacement in the target knee
- Arthroscopy or injections into the target knee within the last 90 days
- Any other joint disease in the target knee, including gout and pseudogout
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- 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)
Who cannot take part
- 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 more than or equal to (≥) 6.5% [(48 millimoles per mole (mmol/mol)] as measured by the central laboratory at screening
- Any joint prosthesis or joint replacement in target knee
Where in United States
Also in 9 other countries, 57 sites
- Northwest Clinical Research CenterBellevue, United StatesContact: Novo NordiskTaking people
- Elite Clinical TrialsBlackfoot, United StatesContact: Novo NordiskTaking people
- Charlottesville Med ResearchCharlottesville, United StatesContact: Novo NordiskTaking people
- Hope Clin Res & WellnessConyers, United StatesContact: Novo NordiskTaking people
- CenExel iResearch, LLCDecatur, United StatesContact: Novo NordiskTaking people
- Chase Medical Research LLCHamden, United StatesContact: Novo NordiskTaking people
- Zenith Clinical ResearchHollywood, United StatesContact: Novo NordiskTaking people
- CNS HealthcareJacksonville, United StatesContact: Novo NordiskTaking people
- Jubilee Clinical Research, Inc.Las Vegas, United StatesContact: Novo NordiskTaking people
- Angels Clinical Research InstituteMiami Lakes, United StatesContact: Novo NordiskTaking people
- Health Res of Hampton RoadsNewport News, United StatesContact: Novo NordiskTaking people
- Coastal Carolina Res CtrNorth Charleston, United StatesContact: Novo NordiskTaking people
- Arizona Research Center, Inc.Phoenix, United StatesContact: Novo NordiskTaking people
- VIP Trials_San AntonioSan Antonio, United StatesContact: Novo NordiskTaking people
- Diablo Clinical Research, Inc.Walnut Creek, United StatesContact: Novo NordiskTaking people
- MedVadis Research WatertownWaltham, United StatesContact: Novo NordiskTaking people
- Chase Medical Research, LLCWaterbury, United StatesContact: Novo NordiskTaking people
- Great Lakes Medical ResearchWestfield, United StatesContact: Novo NordiskTaking people
- Accellacare and KDCILM, LLCWilmington, United StatesContact: Novo NordiskTaking people
About the trial
What the trial wants to find out
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.
The 3 groups in the trial
- NNC0487-0111 dose level 1Treatment being tested
Participants will be randomized to receive NNC0487-0111 dose level 1 subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.
Treatment: NNC0487-0111
- NNC0487-0111 dose level 2Treatment being tested
Participants will be randomized to receive NNC0487-0111 dose level 2 subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.
Treatment: NNC0487-0111
- PlaceboPlacebo, for comparison
Participants will receive placebo matched to NNC0487-0111 subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.
Treatment: Placebo (matched to NNC0487-0111 )
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- Efficacy and Safety of NNC0487-0111 s.c. Once-weekly in Participants With Overweight or Obesity, and Knee Osteoarthritis (AMAZE 5)
- Plain-language title
- NNC0487-0111 for weight loss and knee pain in people with overweight and knee osteoarthritisGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 9 July 2026