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Taking people in Puerto RicoPhase 3

Tests NNC0487-0111 in adults with excess weight and knee osteoarthritis

Tests weekly NNC0487-0111 injections against placebo in adults with excess weight and knee osteoarthritis.

Key facts

Who runs it
Novo Nordisk A/S
Where
San Juan, Puerto RicoSee the siteAlso in 10 other countries, 77 sites
Trial code
Registry 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
Status
Recruiting
Phase
Phase 3
People taking part
400 people, planned
Started
20 Apr 2026
Expected to end
14 Aug 2028
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • NNC0487-0111
  • Placebo (matched to NNC0487-0111)
Record updated
17 August 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 overweight or obesity who have painful knee osteoarthritis. They get a weekly injection of NNC0487-0111 or placebo, chosen by chance.

Age
18 years or older
Sex
Men and women can join
Disease stage
Knee osteoarthritis diagnosed by a doctor, with changes on X-ray (Kellgren Lawrence grades 2 to 4) in the target knee. Knee pain began more than 90 days before screening, and pain on more than 15 days in the last 30 days.
Earlier treatment
Cannot have had GLP-1 receptor agonist treatment, dual GLP-1/GIP treatment or amylin analogues before screening. Cannot have had arthroscopy or injections into the target knee in the last 90 days.

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
  • Joint prosthesis or joint replacement in the target knee
  • Other joint disease in the target knee, including gout and pseudogout
  • Not willing to stop pain medicines for 72 hours before the pain questionnaire visits

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 (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)

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 (HbA1c) ≥ 6.5% (48 mmol/mol) as measured by the central laboratory at screening
  • Any joint prosthesis or joint replacement in target knee

Where in Puerto Rico

Also in 10 other countries, 77 sites

  • Latin Clinical Trial Center Puerto RicoSan Juan, Puerto RicoContact: Novo NordiskTaking people

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • NNC0487-0111Treatment being tested

    Participants will be randomized to receive 1 of the 2 dose levels of NNC0487-0111 subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.

  • 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

  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

Data 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 6)
Plain-language title
Tests NNC0487-0111 in adults with excess weight 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 13 November 2026.
Record updated
17 August 2026