Testing NNC0487-0111 against a placebo for obesity
Official 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
Efficacy and Safety of NNC0487-0111 s.c. Once-weekly in Participants With Overweight or Obesity, and Knee Osteoarthritis (AMAZE 6)
- Phase 3
- 2 groups
- Sites in Surrey, Niagara Falls and 4 more cities
- Recruiting
Interventions
- Medication
NNC0487-0111
NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.
- Medication
Placebo (matched to NNC0487-0111)
Placebo matched to NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.
Canadian Sites (6)
5 of 6 recruiting
- Recruiting
Your Research Network
Niagara Falls, Ontario
- Recruiting
ALPHA Recherche Clinique
Lévis, Quebec
- Recruiting
Centre Medical Acadie
Montreal, Quebec
- Recruiting
ALPHA Recherche Clinique
Québec, Quebec
- Recruiting
Centre de Recherche du CHUS
Sherbrooke, Quebec
- Not yet recruiting
TLC Diabetes and Endocrinology
Surrey, British Columbia
Eligibility Criteria
See who this study is looking for11 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +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 screeningScreeningThe checks done before joining, to see whether a study fits.Read more →. If pain in knees is equal, the target knee joint will be the dominant leg
- +Male or female (sex at birth)
- +Age 18 years or above at the time of signing the informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →
- +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 periodWashout periodA gap with no treatment, so the previous one clears your system.Read more → 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 screeningScreeningThe checks done before joining, to see whether a study fits.Read more →
- −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
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives NNC0487-0111.
Registry label: A: NNC0487-0111
Group B, the placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group, receives Placebo (matched to NNC0487-0111).
Registry label: B: Placebo
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 400 people.
The study is currently expected to finish around August 2028.
The main measurement is taken over: From baselineBaselineYour starting measurements, taken before treatment begins.Read more → (week 0) to week 80.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Relative change in body weight — measured over From baselineBaselineYour starting measurements, taken before treatment begins.Read more → (week 0) to week 80.
Change in Western Ontario and McMaster Universities Osteoarthritis Index Numerical Rating Scale (NRS) 3.1 (24-hour) (WOMAC) pain score — measured over From baseline (week 0) to week 80.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07509307 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About NNC0487-0111Drug
NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Placebo (matched to NNC0487-0111)Drug
Placebo matched to NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: From baselineBaselineYour starting measurements, taken before treatment begins.Read more → (week 0) to week 80.
The study as a whole is currently expected to finish around 2028-08-14.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 400 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 9 locations, including: Surrey, British Columbia, Canada; Niagara Falls, Ontario, Canada; Lévis, Quebec, Canada; Montreal, Quebec, Canada; Québec, Quebec, Canada; Sherbrooke, Quebec, Canada, and 3 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
Other Sites (4)
Arcturus Healthcare, PLC.
Troy, Michigan, United States
NYU Langone Orthopedic Center
New York, New York, United States
Hospital For Special Surgery
New York, New York, United States
Northwest Clinical Research Center
Bellevue, Washington, United States
Think this trial might be right for you?
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.