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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат 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.
• Препарат 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.

Первичные конечные точки

• Relative change in body weight [Срок оценки: 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 [Срок оценки: From baseline (week 0) to week 80]

Вторичные конечные точки (12)

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

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 19 центров

• 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
• … и ещё 11 центров

Испания · 11 центров

• 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
• … и ещё 3 центра

Польша · 9 центров

• "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
• … и ещё 1 центр

Греция · 7 центров

• 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

Италия · 7 центров

• 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 центров

• 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
• … и ещё 1 центр

Болгария · 6 центров

• 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

Канада · 6 центров

• 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

Австралия · 5 центров

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

Дания · 3 центра

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

Пуэрто-Рико · 1 центр

• Latin Clinical Trial Center Puerto Rico — San Juan

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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