Recruiting
Phase 3

NNC0487-0111

Sponsor:

Novo Nordisk A/S

Code:

NCT07481630

Conditions

Obesity

Knee Osteoarthritis (OA)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

NNC0487-0111

Placebo (matched to NNC0487-0111 )

Study Details

Brief 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.

Conditions

Obesity

Knee Osteoarthritis (OA)

Study ID

NCT07481630

Start date

Apr 13, 2026

Status verified date

Jul, 2026

Completion date

Aug 14, 2028

Anticipated

Primary completion date

Aug 14, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: NNC0487-0111 dose level 1

Participants will be randomized to receive NNC0487-0111 dose level 1 subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.

experimental: NNC0487-0111 dose level 2

Participants will be randomized to receive NNC0487-0111 dose level 2 subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.

placebo comparator: Placebo

Participants will receive placebo matched to NNC0487-0111 subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.

Interventions

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.

Primary outcome measure

  • Relative change in body weight [ Time Frame: From baseline (week 0) to (week 80) ]
  • Change in WOMAC Osteoarthritis Index NRS 3.1 (24-hour) (WOMAC) pain score [ Time Frame: From baseline (week 0) to (week 80) ]

Central Contacts and Locations

Central contacts

Novo Nordisk

(+1) 866-867-7178clinicaltrials@novonordisk.com

Locations

Arizona Research Center, Inc.

Recruiting

Phoenix, Arizona, United States, 85053

Diablo Clinical Research, Inc.

Recruiting

Walnut Creek, California, United States, 94598

Chase Medical Research LLC

Recruiting

Hamden, Connecticut, United States, 06517

Chase Medical Research LLC

Recruiting

Waterbury, Connecticut, United States, 06708

Zenith clinical research

Recruiting

Hollywood, Florida, United States, 33021

CNS Healthcare

Recruiting

Jacksonville, Florida, United States, 32256

Angels Clinical Research Institute

Recruiting

Miami Lakes, Florida, United States, 33016

Hope Clin Res & Wellness

Recruiting

Conyers, Georgia, United States, 30094

CenExel iResearch, LLC

Recruiting

Decatur, Georgia, United States, 30030

Elite Clinical Trials

Recruiting

Blackfoot, Idaho, United States, 83221

MedVadis Research Watertown

Recruiting

Waltham, Massachusetts, United States, 02451

Jubilee Clinical Research, Inc.

Recruiting

Las Vegas, Nevada, United States, 89106

Great Lakes Medical Research

Recruiting

Westfield, New York, United States, 14787

Accellacare and KDCILM, LLC

Recruiting

Wilmington, North Carolina, United States, 28401

Coastal Carolina Res Ctr

Recruiting

North Charleston, South Carolina, United States, 29405

VIP Trials_San Antonio

Recruiting

San Antonio, Texas, United States, 78230

Charlottesville Med Research

Recruiting

Charlottesville, Virginia, United States, 22911

Health Res of Hampton Roads

Recruiting

Newport News, Virginia, United States, 23606

Northwest Clinical Research Center

Recruiting

Bellevue, Washington, United States, 98007

Laser Rejuvenation Clinics Inc.

Recruiting

Calgary, Alberta, Canada, T2W 4X9

Dawson Clinical Research

Recruiting

Guelph, Ontario, Canada, N1H 1B1

Centre de Recherche Musculo

Recruiting

Trois-Rivières, Quebec, Canada, G8Z 1Y2

Alpha Recherche Clinique - Lebourgneuf

Recruiting

Québec, Canada, G2J OC4

More Information

Sponsor

Novo Nordisk A/S

Last update posted

Jul 9, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Novo Nordisk A/S on 2026-07-09.