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

NCT07509307 · tracked via the Priya Life Science USA tracker

Sponsor

Novo Nordisk A/S

Phase

Phase 3

Started

2026-04-20

Last updated

2026-08-17

Condition(s) studied

ObesityOverweightOsteoarthritis, Knee

Investigational drug(s) / intervention(s)

NNC0487-0111 →Placebo (matched to NNC0487-0111)

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.

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Relative change in body weight — From baseline (week 0) to week 80
Measured as percentage change in body weight.
Change in Western Ontario and McMaster Universities Osteoarthritis Index Numerical Rating Scale (NRS) 3.1 (24-hour) (WOMAC) pain score — From baseline (week 0) to week 80
WOMAC is a participant reported outcome (PRO) measures symptoms in the areas of pain, stiffness, and physical function in participants with osteoarthritis of the hip and/or knee. 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. Subscale score for pain ranges 0-100, where higher score indicates worse pain. Measured as score on a scale.

Trial sites (81)

Facility	City	Region	Status
Neighborhood Healthcare	Escondido	California	Recruiting
First Valley Medical Group	Lancaster	California	Recruiting
Desert Oasis Healthcare	Palm Springs	California	Recruiting
Chase Medical Research LLC	Waterbury	Connecticut	Recruiting
Westside Center For Clinical Research	Jacksonville	Florida	Recruiting
Clinical Neuroscience Solutions, LLC	Jacksonville	Florida	Recruiting
Advanced Res for Health Improve	Naples	Florida	Recruiting
Clinical Investigation Spec Gurnee	Gurnee	Illinois	Recruiting
Evanston Premier Hlthcr Res	Skokie	Illinois	Recruiting
Monroe Biomedical Research, LLC	Louisville	Kentucky	Recruiting
Arcturus Healthcare, PLC.	Troy	Michigan	Recruiting
Clinvest Research	Springfield	Missouri	Recruiting
NYU Langone Orthopedic Center	New York	New York	Not Yet Recruiting
Hospital For Special Surgery	New York	New York	Recruiting
Piedmont Healthcare/Research	Statesville	North Carolina	Recruiting
Northwest Research Center	Portland	Oregon	Recruiting
Mercy Family Clinic	Dallas	Texas	Recruiting
Health Res of Hampton Roads	Newport News	Virginia	Recruiting
Northwest Clinical Research Center	Bellevue	Washington	Recruiting
Emeritus Research Sydney	Botany	New South Wales	Recruiting
Momentum Clinical Research Darlinghurst	Darlinghurst	New South Wales	Recruiting
Kolling Institute	St Leonards	New South Wales	Recruiting
Heart of Australia	Chelmer	Queensland	Recruiting
Coastal Digestive Health	Maroochydore	Queensland	Recruiting
UMHAT Sveti Georgi EAD, Plovdiv	Plovdiv	Bulgaria	Recruiting
MC Dr. Atanasov EOOD	Sofia	Bulgaria	Recruiting
MC Excelsior OOD	Sofia	Bulgaria	Recruiting
UMHAT Tsaritsa Yoanna - ISUL EAD, Orthopaedics and Traumatology	Sofia	Bulgaria	Recruiting
MMA MHAT - Sofia, Rheumatology clinic	Sofia	Bulgaria	Recruiting
UMHAT Sveti Ivan Rilski EAD, Rheumatology	Sofia	Bulgaria	Recruiting
TLC Diabetes and Endocrinology	Surrey	British Columbia	Not Yet Recruiting
Your Research Network	Niagara Falls	Ontario	Recruiting
ALPHA Recherche Clinique	Lévis	Quebec	Recruiting
Centre Medical Acadie	Montreal	Quebec	Recruiting
ALPHA Recherche Clinique	Québec	Quebec	Recruiting
Centre de Recherche du CHUS	Sherbrooke	Quebec	Recruiting
Aarhus Universitetshospital - Klinik for Led og bindevævssygdomme	Aarhus N	Denmark	Recruiting
Frederiksberg Hospital - Parker Institutet (Artrose)	Frederiksberg	Denmark	Recruiting
Sanos Clinic - Herlev	Herlev	Denmark	Recruiting
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara - 2nd dept of Internal medicine	Chaïdári	Attica	Recruiting

+ 41 more sites — see the full list on the official registry below.

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AMAZE 4: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Obstructive Sleep Apnoea Treated With Positive Airway Pressure Lose Weight and Improve Sleep Apnoea Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07509307 on ClinicalTrials.gov ↗ ← All trials in the USA