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 | Recruiting Phase 3 FDA Drug

• 3 other identifiers: NN9490-8294U1111-1313-69542024-520445-23
• Study Type: interventional
• Target: 400
• Locations: 11 countries
• Sites: 81

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

Outcome Measures

Primary Outcomes (2)

• Relative change in body weight

  Measured as percentage change in body weight.

  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

  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.

  From baseline (week 0) to week 80

Secondary Outcomes (27)

• Change in WOMAC physical function score

  From baseline (week 0) to week 80

• Change in SF-36v2® Health Survey Acute (SF-36v2 Acute) physical functioning score

  From baseline (week 0) to week 80

• Change in body weight

  From baseline (week 0) to week 80

• Change in body mass index (BMI)

  From baseline (week 0) to week 80

• Change in WOMAC stiffness score

  From baseline (week 0) to week 80

Study Arms (2)

NNC0487-0111

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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)

Interventions

NNC0487-0111 DRUG

NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.

NNC0487-0111

Placebo (matched to NNC0487-0111) DRUG

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.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (81)

Neighborhood Healthcare

Escondido, California, 92025, United States

RECRUITING

First Valley Medical Group

Lancaster, California, 93534, United States

NOT YET RECRUITING

Desert Oasis Healthcare

Palm Springs, California, 92262, United States

RECRUITING

Chase Medical Research LLC

Waterbury, Connecticut, 06708, United States

RECRUITING

Westside Center For Clinical Research

Jacksonville, Florida, 32205, United States

RECRUITING

CNS Healthcare

Jacksonville, Florida, 32256, United States

RECRUITING

Advanced Res for Health Improve

Naples, Florida, 34102, United States

RECRUITING

Clinical Investigation Spec Gurnee

Gurnee, Illinois, 60031, United States

RECRUITING

Evanston Premier Hlthcr Res

Skokie, Illinois, 60077, United States

RECRUITING

Monroe Biomedical Research, LLC

Louisville, Kentucky, 40213, United States

RECRUITING

Arcturus Healthcare, PLC.

Troy, Michigan, 48098-6368, United States

RECRUITING

Clinvest Research

Springfield, Missouri, 65807, United States

RECRUITING

NYU Langone Orthopedic Center

New York, New York, 10016, United States

NOT YET RECRUITING

Hospital For Special Surgery

New York, New York, 10021, United States

NOT YET RECRUITING

Piedmont Healthcare/Research

Statesville, North Carolina, 28625, United States

RECRUITING

Northwest Research Center

Portland, Oregon, 97202, United States

RECRUITING

Mercy Family Clinic

Dallas, Texas, 75208, United States

NOT YET RECRUITING

Health Res of Hampton Roads

Newport News, Virginia, 23606, United States

RECRUITING

Northwest Clinical Research Center

Bellevue, Washington, 98007, United States

RECRUITING

Emeritus Research Sydney

Botany, New South Wales, 2019, Australia

RECRUITING

Momentum Clinical Research Darlinghurst

Darlinghurst, New South Wales, 2010, Australia

RECRUITING

Kolling Institute

St Leonards, New South Wales, 2065, Australia

RECRUITING

Heart of Australia

Chelmer, Queensland, 4068, Australia

RECRUITING

Coastal Digestive Health

Maroochydore, Queensland, 4558, Australia

RECRUITING

UMHAT Sveti Georgi EAD, Plovdiv

Plovdiv, 4002, Bulgaria

RECRUITING

MC Dr. Atanasov EOOD

Sofia, 1231, Bulgaria

RECRUITING

MC Excelsior OOD

Sofia, 1407, Bulgaria

RECRUITING

UMHAT Tsaritsa Yoanna - ISUL EAD, Orthopaedics and Traumatology

Sofia, 1527, Bulgaria

RECRUITING

MMA MHAT - Sofia, Rheumatology clinic

Sofia, 1606, Bulgaria

RECRUITING

UMHAT Sveti Ivan Rilski EAD, Rheumatology

Sofia, 1612, Bulgaria

RECRUITING

TLC Diabetes and Endocrinology

Surrey, British Columbia, V3T 2V6, Canada

NOT YET RECRUITING

Your Research Network

Niagara Falls, Ontario, L2H 1H5, Canada

RECRUITING

ALPHA Recherche Clinique

Lévis, Quebec, G6V 0C9, Canada

RECRUITING

Centre Medical Acadie

Montreal, Quebec, H4N 2W2, Canada

RECRUITING

ALPHA Recherche Clinique

Québec, Quebec, G3K 2P8, Canada

RECRUITING

Centre de Recherche du CHUS

Sherbrooke, Quebec, J1H 5N4, Canada

RECRUITING

Aarhus Universitetshospital - Klinik for Led og bindevævssygdomme

Aarhus N, 8200, Denmark

RECRUITING

Frederiksberg Hospital - Parker Institutet (Artrose)

Frederiksberg, 2000, Denmark

RECRUITING

Sanos Clinic - Herlev

Herlev, 2730, Denmark

RECRUITING

University General Hospital Attikon General Hospital Of West Attica H Agia Varvara - 2nd dept of Internal medicine

Chaïdári, Attica, 12461, Greece

NOT YET RECRUITING

Evangelismos S.A. - Endocrinology department

Athens, 10676, Greece

RECRUITING

Laiko General Hospital Of Athens - 1st department of Internal Medicine

Athens, 115 27, Greece

RECRUITING

Athens Medical Center S.A. (Iatriko Psychicou) - Department of Internal Medicine & Metabolic Diseases

Athens, 11525, Greece

RECRUITING

Athens Medical Center S.A. (Iatriko Athinon) - Diabetes and Obesity Unit

Marousi, 15125, Greece

RECRUITING

NextHealth S.A. - Department of Endocrinology, Metabolism & Diabetes

Thessaloniki, 54635, Greece

RECRUITING

Thermi Clinic S.A. - Diabetes and Internal Medicine Department

Thessaloniki, 57001, Greece

RECRUITING

Ospedale S. Maria della Misericordia - Reparto Endocrinologia e Malattie del Metabolismo

Udine, Friuli Venezia Giulia, 33100, Italy

NOT YET RECRUITING

Casa della Salute di Ceccano - Ambulatori Campus Biomedico

Rome, Lazio, 00128, Italy

NOT YET RECRUITING

Pol. Uni. Campus Biomedico - UOC Endocrinologia e Diabetologia

Rome, Lazio, 00128, Italy

NOT YET RECRUITING

Auxologico San Luca - Endocrinologia e Malattie del Metabolismo

Milan, Lombardy, 20149, Italy

NOT YET RECRUITING

Ospedale Galeazzi S.p.A. - INCO - Istituto Nazionale per la Cura dell'Obesità

Milan, Lombardy, 20157, Italy

NOT YET RECRUITING

Policlinico San Donato di Milano S.p.A - UOS Endocrinologia e del Servizio di Nutrizione Clinica e Prevenzione Cardiometabolica

San Donato Milanese, Lombardy, 20097, Italy

NOT YET RECRUITING

Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Civile Maggiore Borgo Trento - U.O. Reumatologia

Verona, Veneto, 37126, Italy

NOT YET RECRUITING

"Zdrowie Osteo-Medic" s.c. Lidia i Artur Racewicz, Agnieszka i Jerzy Supronik

Bialystok, Podlaskie Voivodeship, 15-351, Poland

RECRUITING

ClinicMed Daniluk, Nowak Spółka Komandytowa

Bialystok, 15-879, Poland

RECRUITING

Centrum Medyczne Intercor Sp. z o.o.

Bydgoszcz, 85-605, Poland

RECRUITING

Centrum Medyczne Intercor Sp. z o.o.

Bydgoszcz, 85-605, Poland

NOT YET RECRUITING

CenterMed Kraków Sp. z o.o.

Krakow, 31-530, Poland

RECRUITING

CenterMed Kraków Sp. z o.o.

Krakow, 31-530, Poland

NOT YET RECRUITING

Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie Sp. z o.o.

Krakow, 31-826, Poland

RECRUITING

Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie Sp. z o.o.

Krakow, 31-826, Poland

NOT YET RECRUITING

Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. prof. dr hab. med. Eleonory Reicher

Warsaw, 02-637, Poland

RECRUITING

Latin Clinical Trial Center Puerto Rico

San Juan, 00909, Puerto Rico

RECRUITING

Instituto Medico Quirurgico San Rafael

A Coruña, 15006, Spain

NOT YET RECRUITING

Hospital Germans Trias i Pujol

Badalona, 08916, Spain

NOT YET RECRUITING

Hospital Naval Ferrol

Ferrol, 15405, Spain

RECRUITING

Centro Especialidades Hermanos Sangro

Madrid, 28038, Spain

NOT YET RECRUITING

Hospital Quirónsalud Málaga

Málaga, 29004, Spain

RECRUITING

Hospital Infanta Sofía

San Sebastián de Los Reyes (Madrid), 28702, Spain

RECRUITING

Hospital Universitario Marqués de Valdecilla

Santander, 39008, Spain

RECRUITING

Hospital HM La Esperanza

Santiago de Compostela, 15705, Spain

RECRUITING

Clínica Nuevas Tecnologías en Diabetes y Endocrinología

Seville, 41003, Spain

RECRUITING

H. Infanta Luisa_Endocrino y Obesidad

Seville, 41010, Spain

RECRUITING

Hospital General de Valencia

Valencia, 46014, Spain

RECRUITING

İstanbul Fizik Tedavi ve Rehabilitasyon Eğitim ve Araştırma Hastanesi

Bahçelievler/İstanbul, 34186, Turkey (Türkiye)

RECRUITING

Ankara Bilkent Şehir Hastanesi- Fizik Tedavi ve Rehabilitasyon

Çankaya/Ankara, 06800, Turkey (Türkiye)

RECRUITING

SBÜ Ankara Gaziler Fizik Tedavi Ve Rehabilitasyon Eğitim Ve Araştırma Hastanesi

Çankaya/Ankara, 06800, Turkey (Türkiye)

RECRUITING

Trakya Üniversitesi Tıp Fakültesi Hastanesi-Fizik Tedavi ve Rehabilitasyon

Edirne, 22030, Turkey (Türkiye)

RECRUITING

Istanbul Üniversitesi- Istanbul Tıp Fakültesi Esnaf Hastanesi Poliklinikleri Fiziksel Tıp Ve Rehabilitasyon Anabilim Dalı

Fatih/İstanbul, 34116, Turkey (Türkiye)

RECRUITING

Adana Şehir Eğitim ve Araştırma Hastanesi-Fizik Tedavi ve Rehabilitasyon

Yuregir/Adana, 01060, Turkey (Türkiye)

RECRUITING

Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi-Fizik Tedavi ve Rehabilitasyon

Yıldırım/Bursa, 16310, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Obesity; Overweight; Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Central Study Contacts

Novo Nordisk

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sponsor staff involved in the clinical trial is masked according to company standard procedures.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2026
• First Posted: April 3, 2026
• Study Start: April 20, 2026
• Primary Completion (Estimated): August 14, 2028
• Study Completion (Estimated): August 14, 2028
• Last Updated: May 15, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

BU (6); GR (7); IT (7); DK (3); US (19); CA (6); PR (1); ES (11); AU (5); PL (9); TU (7)