Recruiting

Phase 3

NNC0487-0111AMAZE 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

Sponsor:

Novo Nordisk A/S

Code:

NCT07509307

Conditions

Obesity

Overweight

Osteoarthritis, Knee

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

NNC0487-0111

Placebo (matched to NNC0487-0111)

Study Details

Brief 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.

Conditions

Obesity

Overweight

Osteoarthritis, Knee

Study ID

NCT07509307

Start date

Apr 20, 2026

Status verified date

Aug, 2026

Completion date

Aug 14, 2028

Anticipated

Primary completion date

Aug 14, 2028

Anticipated

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 (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 Design

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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 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 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 ]

Central Contacts and Locations

Central contacts

Novo Nordisk

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

Locations

Neighborhood Healthcare

Recruiting

Escondido, California, United States, 92025

First Valley Medical Group

Recruiting

Lancaster, California, United States, 93534

Desert Oasis Healthcare

Recruiting

Palm Springs, California, United States, 92262

Chase Medical Research LLC

Recruiting

Waterbury, Connecticut, United States, 06708

Westside Center For Clinical Research

Recruiting

Jacksonville, Florida, United States, 32205

Clinical Neuroscience Solutions, LLC

Recruiting

Jacksonville, Florida, United States, 32256

Advanced Res for Health Improve

Recruiting

Naples, Florida, United States, 34102

Clinical Investigation Spec Gurnee

Recruiting

Gurnee, Illinois, United States, 60031

Evanston Premier Hlthcr Res

Recruiting

Skokie, Illinois, United States, 60077

Monroe Biomedical Research, LLC

Recruiting

Louisville, Kentucky, United States, 40213

Arcturus Healthcare, PLC.

Recruiting

Troy, Michigan, United States, 48098-6368

Clinvest Research

Recruiting

Springfield, Missouri, United States, 65807

Hospital For Special Surgery

Recruiting

New York, New York, United States, 10021

Piedmont Healthcare/Research

Recruiting

Statesville, North Carolina, United States, 28625

Northwest Research Center

Recruiting

Portland, Oregon, United States, 97202

Mercy Family Clinic

Recruiting

Dallas, Texas, United States, 75208

Health Res of Hampton Roads

Recruiting

Newport News, Virginia, United States, 23606

Northwest Clinical Research Center

Recruiting

Bellevue, Washington, United States, 98007

Your Research Network

Recruiting

Niagara Falls, Ontario, Canada, L2H 1H5

ALPHA Recherche Clinique

Recruiting

Lévis, Quebec, Canada, G6V 0C9

Centre Medical Acadie

Recruiting

Montreal, Quebec, Canada, H4N 2W2

ALPHA Recherche Clinique

Recruiting

Québec, Quebec, Canada, G3K 2P8

Centre de Recherche du CHUS

Recruiting

Sherbrooke, Quebec, Canada, J1H 5N4

More Information

Sponsor

Novo Nordisk A/S

Last update posted

Aug 17, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-08. This information was provided to ClinicalTrials.gov by Novo Nordisk A/S on 2026-08-17. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.