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Recruiting Phase 3

A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Knee Osteoarthritis Lose Weight and Reduce Pain

NCT07481630 · tracked via the Priya Life Science Italy tracker
Phase
Phase 3
Started
2026-04-13
Last updated
2026-07-09

Condition(s) studied

ObesityKnee Osteoarthritis (OA)

Investigational drug(s) / intervention(s)

NNC0487-0111 →Placebo (matched to NNC0487-0111 )

NNC0487-0111: NNC0487-0111 dose level 1 and dose level 2 will be administered subcutaneously using PDS290 pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.

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.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Relative change in body weight — From baseline (week 0) to (week 80)
    Measured as percentage (%) of body weight.
  • Change in WOMAC Osteoarthritis Index NRS 3.1 (24-hour) (WOMAC) pain score — From 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.

Trial sites (82)

FacilityCityRegionStatus
Arizona Research Center, Inc. Phoenix Arizona Recruiting
Diablo Clinical Research, Inc. Walnut Creek California Recruiting
Chase Medical Research LLC Hamden Connecticut Recruiting
Chase Medical Research LLC Waterbury Connecticut Recruiting
Zenith clinical research Hollywood Florida Recruiting
CNS Healthcare Jacksonville Florida Recruiting
Angels Clinical Research Institute Miami Lakes Florida Recruiting
Hope Clin Res & Wellness Conyers Georgia Recruiting
CenExel iResearch, LLC Decatur Georgia Recruiting
Elite Clinical Trials Blackfoot Idaho Recruiting
MedVadis Research Watertown Waltham Massachusetts Recruiting
Jubilee Clinical Research, Inc. Las Vegas Nevada Recruiting
Great Lakes Medical Research Westfield New York Recruiting
Accellacare and KDCILM, LLC Wilmington North Carolina Recruiting
Coastal Carolina Res Ctr North Charleston South Carolina Recruiting
VIP Trials_San Antonio San Antonio Texas Recruiting
Charlottesville Med Research Charlottesville Virginia Recruiting
Health Res of Hampton Roads Newport News Virginia Recruiting
Northwest Clinical Research Center Bellevue Washington Recruiting
Emeritus Research Sydney Botany New South Wales Recruiting
Momentum Clinical Research Darlinghurst Darlinghurst New South Wales Recruiting
Kolling Institute St Leonards New South Wales Recruiting
Heart of Australia Chelmer Queensland Recruiting
Coastal Digestive Health Maroochydore Queensland Recruiting
UMHAT Sveti Georgi EAD, Plovdiv Plovdiv Bulgaria Recruiting
MC Dr. Atanasov EOOD Sofia Bulgaria Recruiting
MC Excelsior OOD Sofia Bulgaria Recruiting
UMHAT Tsaritsa Yoanna - ISUL EAD, Orthopaedics and Traumatology Sofia Bulgaria Recruiting
MMA MHAT - Sofia, Rheumatology clinic Sofia Bulgaria Recruiting
UMHAT Sveti Ivan Rilski EAD, Rheumatology Sofia Bulgaria Recruiting
Laser Rejuvenation Clinics Inc. Calgary Alberta Recruiting
Dawson Clinical Research Guelph Ontario Recruiting
Hamilton Medical Rsrch Grp Hamilton Ontario Not Yet Recruiting
Centre de Recherche Musculo Trois-Rivières Quebec Recruiting
Alpha Recherche Clinique - Lebourgneuf Québec Canada Recruiting
Aarhus Universitetshospital - Klinik for Led og bindevævssygdomme Aarhus N Denmark Recruiting
Frederiksberg Hospital - Parker Institutet (Artrose) Frederiksberg Denmark Recruiting
Sanos Clinic - Herlev Herlev Denmark Recruiting
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara - 2nd dept of Internal medicine Chaïdári Attica Recruiting
Laiko General Hospital Of Athens - 1st department of Internal Medicine Athens Greece Recruiting

+ 42 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07481630 on ClinicalTrials.gov ↗ ← All trials in Italy