DRUG
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.
Status
Recruiting
Phase
Phase 3
Enrollment
400
Locations
82
Results
Not posted
Publications
0
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.
Interventions
DRUG
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.
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
Mar 19, 2026
Study start
Apr 13, 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 (%) of body weight.
Change in WOMAC Osteoarthritis Index NRS 3.1 (24-hour) (WOMAC) pain score
Time frame · 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.
Change in WOMAC physical function score
Time frame · From baseline (week 0) to (week 80)
Measured as score on a scale. Physical function score will be calculated according to the guidelines provided in the WOMAC User Guide XI. Score ranges from 0-100 and higher scores indicate worse physical function.
Change in SF-36v2® Health Survey Acute (SF-36v2 Acute) physical functioning score
Time frame · From baseline (week 0) to (week 80)
Measured as score on a scale. 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, that is 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.
Change in body weight
Time frame · From baseline (week 0) to (week 80)
Measured as kilogram (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)
Measured as score on a scale. Stiffness score will be calculated according to the guidelines provided in the WOMAC User Guide XI. Score ranges from 0-100 and higher scores indicate worse stiffness.
Change in WOMAC total score
Time frame · From baseline (week 0) to (week 80)
Measured as score on a scale. Total score will be calculated according to the guidelines provided in the WOMAC User Guide XI. Total score ranges from 0-100 and higher scores indicate worse overall osteoarthritis- related disability.
Change in waist circumference
Time frame · From baseline (week 0) to (week 80)
Measured as centimetre (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.
Change in total cholesterol
Time frame · From baseline (week 0) to (week 80)
Measured as ratio to baseline.
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 (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.
Study locations
Australia · Bulgaria · Canada · Denmark · Greece · Italy · Poland · Spain · Turkey (Türkiye) · United States. Showing up to 24 locations stored in the fast local snapshot.
Arizona Research Center, Inc.
Phoenix, Arizona, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, United States
Chase Medical Research LLC
Hamden, Connecticut, United States
Chase Medical Research LLC
Waterbury, Connecticut, United States
Zenith clinical research
Hollywood, Florida, United States
CNS Healthcare
Jacksonville, Florida, United States
Angels Clinical Research Institute
Miami Lakes, Florida, United States
Hope Clin Res & Wellness
Conyers, Georgia, United States
CenExel iResearch, LLC
Decatur, Georgia, United States
Elite Clinical Trials
Blackfoot, Idaho, United States
MedVadis Research Watertown
Waltham, Massachusetts, United States
Jubilee Clinical Research, Inc.
Las Vegas, Nevada, United States
Great Lakes Medical Research
Westfield, New York, United States
Accellacare and KDCILM, LLC
Wilmington, North Carolina, United States
Coastal Carolina Res Ctr
North Charleston, South Carolina, United States
VIP Trials_San Antonio
San Antonio, Texas, United States
Charlottesville Med Research
Charlottesville, Virginia, 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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