Research Study for Excess Body Weight and Knee Osteoarthritis

This study is investigating a medicine called NNC0487-0111 to see if it can help people with excess body weight and knee osteoarthritis (a common type of arthritis that affects the knees) lose weight and reduce pain. You could be eligible if you are 18 or older and have a clinical diagnosis of knee osteoarthritis with specific radiographic (X-ray) changes. The study will measure changes in your body weight and knee pain over 80 weeks. Participants will receive weekly injections under the skin of either NNC0487-0111 or a placebo (an inactive substance that looks like the study medicine). The study aims to enroll 400 participants, but its current recruitment status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It involves 400 planned participants who will be randomly assigned to receive either NNC0487-0111 or a placebo.
What's involved
Participants will receive weekly injections under the skin, administered to the thigh, abdomen, or upper arm. The study will track changes in body weight and pain for 80 weeks.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 80 weeks to measure changes in body weight and knee pain.

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NCT07481630

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 2026-07-09 on ClinicalTrials.gov
What's tested:NNC0487-0111Placebo (matched to NNC0487-0111 )

At a glance

Recruiting sites
73 of 82 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
Obesity
Knee Osteoarthritis (OA)
82 sites across 34 states
Spain11
Poland10
Turkey (Türkiye)7
Bulgaria6
Greece6
Florida3
New South Wales3
Denmark3
  • Clinical Transparency (dept. 2834) · STUDY_DIRECTOR · Novo Nordisk A/S

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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 (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

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

    Measured as percentage (%) of body weight.

  • Change in WOMAC Osteoarthritis Index NRS 3.1 (24-hour) (WOMAC) pain scoreFrom baseline (week 0) to (week 80)

    Measured as score on a scale. Western Ontario and McMaster Universities Arthritis Index (WOMAC) measures symptoms in the areas of pain, stiffness, and physical function. 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.