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

Official title

Efficacy and Safety of NNC0487-0111 s.c. Once-weekly in Participants With Overweight or Obesity, and Knee Osteoarthritis (AMAZE 6)

Overview

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.

Interventions

• 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.
• 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.

Primary outcome measures

• 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]

Secondary outcome measures (12)

• Change in WOMAC physical function score [Time frame: From baseline (week 0) to week 80]
• Change in SF-36v2® Health Survey Acute (SF-36v2 Acute) physical functioning score [Time frame: From baseline (week 0) to week 80]
• Change in body weight [Time frame: From baseline (week 0) to week 80]
• Change in body mass index (BMI) [Time frame: From baseline (week 0) to week 80]
• Change in WOMAC stiffness score [Time frame: From baseline (week 0) to week 80]
• Change in WOMAC total score [Time frame: From baseline (week 0) to week 80]
• Change in waist circumference [Time frame: From baseline (week 0) to week 80]
• Change in systolic blood pressure (SBP) [Time frame: From baseline (week 0) to week 80]
• Change in diastolic blood pressure (DBP) [Time frame: From baseline (week 0) to week 80]
• Ratio to baseline: change in total cholesterol [Time frame: From baseline (week 0) to week 80]
• Ratio to baseline: change in high-density lipoprotein (HDL) cholesterol [Time frame: From baseline (week 0) to week 80]
• Ratio to baseline: change in low-density lipoprotein (LDL) cholesterol [Time frame: From baseline (week 0) to week 80]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

United States · 19 centers

• Neighborhood Healthcare — Escondido
• First Valley Medical Group — Lancaster
• Desert Oasis Healthcare — Palm Springs
• Chase Medical Research LLC — Waterbury
• Westside Center For Clinical Research — Jacksonville
• Clinical Neuroscience Solutions, Inc. — Jacksonville
• Advanced Res for Health Improve — Naples
• Clinical Investigation Spec Gurnee — Gurnee
• … and 11 more centers

Spain · 11 centers

• Instituto Medico Quirurgico San Rafael — A Coruña
• Hospital Germans Trias i Pujol — Badalona
• Hospital Naval Ferrol — Ferrol
• Centro Especialidades Hermanos Sangro — Madrid
• Hospital Quirónsalud Málaga — Málaga
• Hospital Infanta Sofía — San Sebastián de Los Reyes (Madrid)
• Hospital Universitario Marqués de Valdecilla — Santander
• Hospital HM La Esperanza — Santiago de Compostela
• … and 3 more centers

Poland · 9 centers

• "Zdrowie Osteo-Medic" s.c. Lidia i Artur Racewicz, Agnieszka i Jerzy Supronik — Bialystok
• ClinicMed Daniluk, Nowak Spółka Komandytowa — Bialystok
• Centrum Medyczne Intercor Sp. z o.o. — Bydgoszcz
• Centrum Medyczne Intercor Sp. z o.o. — Bydgoszcz
• CenterMed Kraków Sp. z o.o. — Krakow
• CenterMed Kraków Sp. z o.o. — Krakow
• Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie Sp. z o.o. — Krakow
• Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie Sp. z o.o. — Krakow
• … and 1 more center

Greece · 7 centers

• University General Hospital Attikon General Hospital Of West Attica H Agia Varvara - 2nd d — Chaïdári
• Evangelismos S.A. - Endocrinology department — Athens
• Laiko General Hospital Of Athens - 1st department of Internal Medicine — Athens
• Athens Medical Center S.A. (Iatriko Psychikou) - Department of Internal Medicine & Metabol — Athens
• Athens Medical Center S.A. (Iatriko Athinon) - Diabetes and Obesity Unit — Marousi
• NextHealth S.A. - Department of Endocrinology, Metabolism & Diabetes — Thessaloniki
• Thermi Clinic S.A. - Diabetes and Internal Medicine Department — Thessaloniki

Italy · 7 centers

• Ospedale S. Maria della Misericordia - Reparto Endocrinologia e Malattie del Metabolismo — Udine
• Casa della Salute di Ceccano - Ambulatori Campus Biomedico — Rome
• Pol. Uni. Campus Biomedico - UOC Endocrinologia e Diabetologia — Rome
• Auxologico San Luca - Endocrinologia e Malattie del Metabolismo — Milan
• Ospedale Galeazzi S.p.A. - INCO - Istituto Nazionale per la Cura dell'Obesità — Milan
• Policlinico San Donato di Milano S.p.A - UOS Endocrinologia e del Servizio di Nutrizione C — San Donato Milanese
• Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Civile Maggiore Borgo Trento — Verona

Turkey (Türkiye) · 7 centers

• İstanbul Fizik Tedavi ve Rehabilitasyon Eğitim ve Araştırma Hastanesi — Bahçelievler/İstanbul
• Ankara Bilkent Şehir Hastanesi- Fizik Tedavi ve Rehabilitasyon — Çankaya/Ankara
• SBÜ Ankara Gaziler Fizik Tedavi Ve Rehabilitasyon Eğitim Ve Araştırma Hastanesi — Çankaya/Ankara
• Trakya Üniversitesi Tıp Fakültesi Hastanesi-Fizik Tedavi ve Rehabilitasyon — Edirne
• Istanbul Üniversitesi- Istanbul Tıp Fakültesi Esnaf Hastanesi Poliklinikleri Fiziksel Tıp — Fatih/İstanbul
• Adana Şehir Eğitim ve Araştırma Hastanesi-Fizik Tedavi ve Rehabilitasyon — Yuregir/Adana
• … and 1 more center

Bulgaria · 6 centers

• UMHAT Sveti Georgi EAD, Plovdiv — Plovdiv
• MC Dr. Atanasov EOOD — Sofia
• MC Excelsior OOD — Sofia
• UMHAT Tsaritsa Yoanna - ISUL EAD, Orthopaedics and Traumatology — Sofia
• MMA MHAT - Sofia, Rheumatology clinic — Sofia
• UMHAT Sveti Ivan Rilski EAD, Rheumatology — Sofia

Canada · 6 centers

• TLC Diabetes and Endocrinology — Surrey
• Your Research Network — Niagara Falls
• ALPHA Recherche Clinique — Lévis
• Centre Medical Acadie — Montreal
• ALPHA Recherche Clinique — Québec
• Centre de Recherche du CHUS — Sherbrooke

Australia · 5 centers

• Emeritus Research Sydney — Botany
• Momentum Clinical Research Darlinghurst — Darlinghurst
• Kolling Institute — St Leonards
• Heart of Australia — Chelmer
• Coastal Digestive Health — Maroochydore

Denmark · 3 centers

• Aarhus Universitetshospital - Klinik for Led og bindevævssygdomme — Aarhus N
• Frederiksberg Hospital - Parker Institutet (Artrose) — Frederiksberg
• Sanos Clinic - Herlev — Herlev

Puerto Rico · 1 center

• Latin Clinical Trial Center Puerto Rico — San Juan

Identifiers

NCT: NCT07509307 · NN9490-8294 · U1111-1313-6954 · 2024-520445-23

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗