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

Purpose

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)

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • 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.
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.
  • 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.
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.
  • Drug: 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.

Recruiting Locations

Arizona Research Center, Inc.
Phoenix, Arizona 85053

Diablo Clinical Research, Inc.
Walnut Creek, California 94598

Chase Medical Research LLC
Hamden, Connecticut 06517

Chase Medical Research LLC
Waterbury, Connecticut 06708

Zenith clinical research
Hollywood, Florida 33021

CNS Healthcare
Jacksonville, Florida 32256

Angels Clinical Research Institute
Miami Lakes, Florida 33016

Hope Clin Res & Wellness
Conyers, Georgia 30094

CenExel iResearch, LLC
Decatur, Georgia 30030

Elite Clinical Trials
Blackfoot, Idaho 83221

MedVadis Research Watertown
Waltham, Massachusetts 02451

Jubilee Clinical Research, Inc.
Las Vegas, Nevada 89106

Great Lakes Medical Research
Westfield, New York 14787

Accellacare and KDCILM, LLC
Wilmington, North Carolina 28401

Coastal Carolina Res Ctr
North Charleston, South Carolina 29405

VIP Trials_San Antonio
San Antonio, Texas 78230

Charlottesville Med Research
Charlottesville, Virginia 22911

Health Res of Hampton Roads
Newport News, Virginia 23606

Northwest Clinical Research Center
Bellevue, Washington 98007

More Details

Status
Recruiting
Sponsor
Novo Nordisk A/S

Study Contact

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