DRUG
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.
Status
Recruiting
Phase
Phase 3
Enrollment
400
Locations
81
Results
Not posted
Publications
0
Study summary
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.
Interventions
DRUG
NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.
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.
Timeline
First posted
Apr 3, 2026
Study start
Apr 20, 2026
Primary completion
Aug 14, 2028
Study completion
Aug 14, 2028
Results posted
Not reported
Registry updated
Jul 9, 2026
Outcomes
Relative change in body weight
Time frame · From 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 score
Time frame · From 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.
Change in WOMAC physical function score
Time frame · From baseline (week 0) to week 80
WOMAC is a 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 physical function ranges 0-100, where higher score indicates worse physical function. Measured as score on a scale.
Change in SF-36v2® Health Survey Acute (SF-36v2 Acute) physical functioning score
Time frame · From baseline (week 0) to week 80
SF-36v2 Acute measures Health-Related Quality of Life (HRQOL). The measure consists of 36 items yielding 8 health domain scores and 2 component summary scores. SF-36v2 Acute scores are norm-based scores, i.e. transformed to a scale where the 2009 US general population has a mean of 50 and a standard deviation (SD) of 10. Higher scores indicate better functional health and well-being. The physical functioning ranges from 19.0 to 57.6. Measured as score on a scale.
Change in body weight
Time frame · From baseline (week 0) to week 80
Measured as kilograms (kg).
Change in body mass index (BMI)
Time frame · From baseline (week 0) to week 80
Measured as kilograms per meter squared (kg/m\^2).
Change in WOMAC stiffness score
Time frame · From baseline (week 0) to week 80
WOMAC is a 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 stiffness ranges 0-100, where higher score indicates worse stiffness. Measured as score on a scale.
Change in WOMAC total score
Time frame · From baseline (week 0) to week 80
WOMAC is a 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. Total score ranges 0-100, where higher score indicates worse pain, stiffness, physical function and overall osteoarthritis related disability. Measured as score on a scale.
Change in waist circumference
Time frame · From baseline (week 0) to week 80
Measured as centimetres (cm).
Change in systolic blood pressure (SBP)
Time frame · From baseline (week 0) to week 80
Measured as millimetre of mercury (mmHg).
Change in diastolic blood pressure (DBP)
Time frame · From baseline (week 0) to week 80
Measured as mmHg.
Ratio to baseline: change in total cholesterol
Time frame · From baseline (week 0) to week 80
Measured as ratio.
Eligibility
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 (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) Key Exclusion Criteria: * 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
Study locations
Australia · Bulgaria · Canada · Denmark · Greece · Italy · Poland · Puerto Rico · Spain · Turkey (Türkiye) · United States. Showing up to 24 locations stored in the fast local snapshot.
Neighborhood Healthcare
Escondido, California, United States
First Valley Medical Group
Lancaster, California, United States
Desert Oasis Healthcare
Palm Springs, California, United States
Chase Medical Research LLC
Waterbury, Connecticut, United States
Westside Center For Clinical Research
Jacksonville, Florida, United States
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, United States
Advanced Res for Health Improve
Naples, Florida, United States
Clinical Investigation Spec Gurnee
Gurnee, Illinois, United States
Evanston Premier Hlthcr Res
Skokie, Illinois, United States
Monroe Biomedical Research, LLC
Louisville, Kentucky, United States
Arcturus Healthcare, PLC.
Troy, Michigan, United States
Clinvest Research
Springfield, Missouri, United States
NYU Langone Orthopedic Center
New York, New York, United States
Hospital For Special Surgery
New York, New York, United States
Piedmont Healthcare/Research
Statesville, North Carolina, United States
Northwest Research Center
Portland, Oregon, United States
Mercy Family Clinic
Dallas, Texas, United States
Health Res of Hampton Roads
Newport News, Virginia, United States
Northwest Clinical Research Center
Bellevue, Washington, United States
Emeritus Research Sydney
Botany, New South Wales, Australia
Momentum Clinical Research Darlinghurst
Darlinghurst, New South Wales, Australia
Kolling Institute
St Leonards, New South Wales, Australia
Heart of Australia
Chelmer, Queensland, Australia
Coastal Digestive Health
Maroochydore, Queensland, Australia
Publications
No PMID-linked publications were present in this registry snapshot.
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