AMAZE 12: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight Maintain Their Weight Loss

Официальное название

Efficacy and Safety of NNC0487-0111 s.c. Once Weekly in Participants With Obesity Who Have Reached Target Dose During run-in Period (AMAZE 12)

Обзор

The purpose of this clinical study is to find out if NNC0487-0111 is safe and effective for treating people who have excess body weight. 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.
• Препарат Placebo (matched to NNC0487-0111)
  Placebo will be administered subcutaneously.

Первичные конечные точки

• Relative change in body weight [Срок оценки: From week 40 to week 92]

Вторичные конечные точки (12)

• Relative change in body weight [Срок оценки: From week 0 to week 92]
• Change in waist circumference [Срок оценки: From week 40 to week 92]
• Change in systolic blood pressure (SBP) [Срок оценки: From week 40 to week 92]
• Change in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) physical function score [Срок оценки: From week 40 to week 92]
• Change in SF-36v2® Health Survey Acute (SF-36v2 Acute) physical functioning score [Срок оценки: From week 40 to week 92]
• Change in body weight [Срок оценки: From week 40 to week 92]
• Change in body mass index (BMI) [Срок оценки: From week 40 to week 92]
• Change in body weight [Срок оценки: From week 0 to week 92]
• Change in BMI [Срок оценки: From week 0 to week 92]
• Change in glycated haemoglobin (HbA1c) [Срок оценки: From week 40 to week 92]
• Change in fasting plasma glucose (FPG) [Срок оценки: From week 40 to week 92]
• Change in fasting insulin [Срок оценки: From week 40 to week 92]

Критерии участия

Критерии включения

• Male or female (sex at birth).
• Age 18 years or above at the time of signing the informed consent.

Критерии исключения

• Glycated haemoglobin (HbA1c) greater than or equal to ≥ 6.5% \[48 millimoles per mole (mmol/mol)\] 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.

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 · 13 центров

• Pinnacle Research Group LLC — Anniston
• Diablo Clinical Research, Inc. — Walnut Creek
• Florida Inst For Clin Res LLC — Orlando
• Endeavor Health — Skokie
• Midwest Inst For Clin Res — Indianapolis
• Medication Mgmnt, LLC_Grnsboro — Greensboro
• PMG Research of Wilmington LLC — Wilmington
• UPA Ctr Weight and Eating Dis — Philadelphia
• … и ещё 5 центров

Болгария · 8 центров

• DCC 1 - Lom EOOD — Lom
• MHAT Med Line Clinic — Plovdiv
• UMHAT Kaspela EOOD, Endocrinology and Metabolic Diseases Clinic — Plovdiv
• AIPSOMCEMD ENDO MED CONSULT 2020 - Dr. Aleksander Botushanov EOOD — Plovdiv
• SGHAT Dr. Shterev EOOD — Sofia
• UMHAT Aleksandrovska EAD, Clinic of Endocrinology and Metabolic Diseases — Sofia
• Medical Center Maraya Med EOOD — Sofia
• AIPSMC Dr. Traykovska EOOD — Sofia

Италия · 8 центров

• Arcispedale Sant'Anna (Cona) - UO di Endocrinologia — Ferrara
• IRCCS Ospedale Policlinico San Martino - Medicina Interna e Specialità Mediche — Genoa
• Fondazione Salvatore Maugeri I.R.C.C.S. - Pavia - Dipartimento Medicina Interna e Generale — Pavia
• Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone - Presidio Villa Belmonte — Palermo
• Azienda Ospedaliera di Padova - UOSD Chirurgia Bariatrica — Padova
• Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Civile Maggiore Borgo Trento — Verona
• A.O.Universitaria S.ORSOLA-MALPIGHI - U.O.Endocrinologia e Cura — Bologna
• IRCCS Humanitas - U.O. Endocrinologia e Diabetologia — Rozzano (MI)

Германия · 7 центров

• Diabetologikum - Diabetologische Schwerpunktpraxis Dr. Thomas Segiet — Speyer
• Wendisch - Dahl Hamburg - DZHW — Hamburg
• Prof. Dr. Schiefke Ingolf, EUGASTRO GmbH — Leipzig
• Diabetologische Gemeinschaftspraxis Dr. Staudenmeyer und Dr. Schiwietz — Lingen
• Institut für Diabetesforschung GmbH Münster - Dr. med. Rose — Münster
• RED-Institut für medizinische Forschung und Fortbildung GmbH — Oldenburg in Holstein
• Zentrum für klinische Studien Alexander Segner — Saint Ingbert-Oberwürzbach

Испания · 7 центров

• Centro Periferico De Especialidades Bola Azul — Almería
• Hospital Clinic i Provincial — Barcelona
• H. de León_Endocrinología — León
• Hospital Clínico San Carlos — Madrid
• H. Clinico Univ. Virgen de la Victoria — Málaga
• H.U. Quirónsalud Madrid — Pozuelo de Alarcón
• Hospital Universitario Virgen del Rocío — Seville

Франция · 5 центров

• CHU DE CLERMONT-FERRAND-HOPITAL GABRIEL MONTPIED_Service de Nutrition — Clermont-Ferrand
• CHU GRENOBLE ALPES-SITE NORD MICHALLON_Endocrinologie,diabétologie,maladies de la nutritio — La Tronche
• GROUPE SOS SANTE-HOPITAL LE CREUSOT-HOTEL DIEU_ Service de Diabétologie — Le Creusot
• CHU LILLE-HOPITAL CLAUDE HURIEZ_Service de Chirurgie Générale et Endocrinienne — Lille
• CHU DE POITIERS_Centre d'investigation Clinique — Poitiers

Нидерланды · 5 центров

• PreCare Trial & Recruitment — Born
• Progress Clinical Research Den Bosch — 's-Hertogenbosch
• EB Flevo Research BV — Almere Stad
• Meander MC — Amersfoort
• Rijnstate Ziekenhuis — Arnhem

Аргентина · 4 центра

• Conexa — Ciudad Autonoma de Buenos Aires
• CICEMO- Consultorio (Av Directorio) — Ciudad Autónoma de Buenos Aires
• Instituto de Investigaciones Clinicas Mar Del Plata — Mar del Plata
• CIPREC Pueyrredon — Buenos Aires

Австралия · 4 центра

• Sydney Clinical Trials — Campbelltown
• Sydney Cardiometabolic Centre — Liverpool
• Hunter Diabetes Centre — Merewether
• Nightingale Research — Adelaide

Бельгия · 4 центра

• Anima Research Center — Diepenbeek
• AZ Groeninge - Kortrijk - Centrum Endo - Diabetologie — Kortrijk
• Centre hospitalier universitaire de Liège (CHU de Liège) — Liège
• AZ OOSTENDE (Campus DAMIAAN) — Ostend

Великобритания · 4 центра

• EMS Healthcare — Cheshire
• Clifton Medical Centre — Rotherham
• Staploe Medical Centre — Soham
• Albany House Medical Centre — Wellingborough

Дания · 3 центра

• Sjællands Universitetshospital, Køge - Medicinsk Afdeling — Køge
• Sydvestjysk Sygehus Esbjerg - Medicinsk Endokrinologisk Ambulatorium, Forskningsenheden — Esbjerg
• Sanos Clinic - Vejle — Vejle

Идентификаторы

NCT: NCT07503210 · NN9490-8559 · U1111-1327-1477 · 2025-523804-62

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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