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AMAZE 6: NNC0487-0111 for Weight Loss and Knee Pain

This study, called AMAZE 6, is looking at how well a medicine called NNC0487-0111 helps people with excess body weight and knee osteoarthritis (a condition where joint cartilage wears down) to lose weight and reduce pain. You would receive weekly injections under your skin of either NNC0487-0111 or a placebo (a substance with no active medicine). The study aims to see if NNC0487-0111 can lead to a change in body weight and a reduction in knee pain over 80 weeks. To join, you must be at least 18 years old and have a diagnosis of knee osteoarthritis with specific radiographic changes. The study is currently recruiting about 400 participants.

Study design
This is an interventional study where participants are randomly assigned to receive either NNC0487-0111 or a placebo. Approximately 400 people are planned to participate.
What's involved
You would receive weekly injections under your skin in your thigh, abdomen, or upper arm for 80 weeks.
Compensation
Not stated in the trial record.
Follow-up
Your body weight and knee pain will be measured from the start of the study (week 0) up to week 80.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07509307

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
Novo Nordisk A/S
~400 participants
Updated 2026-08-17 on ClinicalTrials.gov
What's tested:NNC0487-0111Placebo (matched to NNC0487-0111)

At a glance

Recruiting sites
74 of 81 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Relative change in body weight
Measured over From baseline (week 0) to week 80
+1 more outcome measured

Conditions

Obesity
Overweight
Osteoarthritis, Knee

Explore related trials

ObesityOsteoarthritisOverweight

Where it's being run

81 sites across 31 states
Spain11
Poland8
Turkey (Türkiye)7
Bulgaria6
Greece6
Quebec4
California3
Florida3

Study leadership

  • Clinical Transparency (dept. 2834) · STUDY_DIRECTOR · Novo Nordisk A/S

Who to contact

Novo Nordisk
[email protected]
(+1) 866-867-7178
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

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

Glycated haemoglobin (HbA1c) ≥ 6.5% (48 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

What this trial measures

  • Relative change in body weightFrom baseline (week 0) to week 80

    Measured as percentage change in body weight.

  • Change in Western Ontario and McMaster Universities Osteoarthritis Index Numerical Rating Scale (NRS) 3.1 (24-hour) (WOMAC) pain scoreFrom baseline (week 0) to week 80

    WOMAC is a participant reported outcome (PRO) measures symptoms in the areas of pain, stiffness, and physical function in participants with osteoarthritis of the hip and/or knee. The measure consists of 24 items yielding 3 subscale scores and 1 total score. WOMAC raw scores are transformed to a standardised 0 to 100 score range. Higher scores indicate worse pain, stiffness, physical function, and overall osteoarthritis-related disability. Subscale score for pain ranges 0-100, where higher score indicates worse pain. Measured as score on a scale.