AMAZE 6: 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

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.

Conditions

  • Obesity
  • Overweight
  • Osteoarthritis, Knee

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 (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)

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 Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Sponsor staff involved in the clinical trial is masked according to company standard procedures.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
NNC0487-0111 		Participants will be randomized to receive 1 of the 2 dose levels of NNC0487-0111 subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.
  • 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.
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

Neighborhood Healthcare
Escondido, California 92025

Desert Oasis Healthcare
Palm Springs, California 92262

Chase Medical Research LLC
Waterbury, Connecticut 06708

Westside Center For Clinical Research
Jacksonville, Florida 32205

CNS Healthcare
Jacksonville, Florida 32256

Advanced Res for Health Improve
Naples, Florida 34102

Clinical Investigation Spec Gurnee
Gurnee, Illinois 60031

Evanston Premier Hlthcr Res
Skokie, Illinois 60077

Monroe Biomedical Research, LLC
Louisville, Kentucky 40213

Arcturus Healthcare, PLC.
Troy, Michigan 48098-6368

Clinvest Research
Springfield, Missouri 65807

Piedmont Healthcare/Research
Statesville, North Carolina 28625

Northwest Research Center
Portland, Oregon 97202

Health Res of Hampton Roads
Newport News, Virginia 23606

Northwest Clinical Research Center
Bellevue, Washington 98007

Latin Clinical Trial Center Puerto Rico
San Juan, Puerto Rico 00909

More Details

Status
Recruiting
Sponsor
Novo Nordisk A/S

Study Contact

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