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
Phase 3Interventional Study
ObesityKnee Osteoarthritis (OA)
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
400 (estimated)
Sponsor
Novo Nordisk A/S · Industry
Who this trial is looking for
This trial is looking for adults with knee osteoarthritis and extra body weight. Participants will receive either an injection of NNC0487-0111 or a placebo once a week to see how it helps with weight loss and pain reduction.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 18 years old.
I have been diagnosed with knee osteoarthritis.
I have had pain in my target knee for more than 15 days in the past 30 days.
I have experienced knee pain for over 90 days.
I am willing to stop taking pain medications for 72 hours before certain visits.
You may not be able to join if
I have a glycated hemoglobin level of 6.5% or higher.
I have a history of type 1 or type 2 diabetes.
I have had any joint surgery or injections in my target knee in the last 90 days.
I have a joint prosthesis or replacement in my target knee.
I have any other joint disease in my target knee.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 p…
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.
Trial Locations
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Eligibility Criteria
Key inclusion Criteria:
* 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 readin…
Key inclusion Criteria:
* 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 Criteria:
* Glycated haemoglobin more than or equal to (≥) 6.5% \[(48 millimoles per mole (mmol/mol)\] 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.
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