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Taking people in ItalyPhase 3

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.

Plain-language title generated from the registry record
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

Key facts

Where
Milan, Modena, Naples, Rome, San Donato Milanese, Udine, and Verona, ItalySee the 7 sites
Phase
Phase 3

AI summary: who the study is looking for

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

Read by machine on 12 November 2026.

Where in Italy

  • Istituto Auxologico ItalianoMilan, ItalyTaking people
  • Azienda Ospedaliero - Universitaria di ModenaModena, ItalyTaking people
  • Azienda Ospedaliera Universitaria Federico II Di NapoliNaples, ItalyTaking people
  • Università Campus Bio-Medico di RomaRome, ItalyTaking people
  • Policlinico San Donato S.p.A.San Donato Milanese, ItalyTaking people
  • Azienda Sanitaria Universitaria Friuli CentraleUdine, ItalyTaking people
  • Azienda Ospedaliera Universitaria Integrata VeronaVerona, ItalyTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Trial details

Who runs it
Novo Nordisk A/S
Trial code
NCT07481630EU 2024-520444-42-00
Record updated
9 July 2026
Original description
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.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 5)

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.

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 (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: 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.

ClinicalTrials.gov NCT07481630 · EU CTIS 2024-520444-42-00