AMAZE 1: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight Lose Weight

Официальное название

Efficacy and Safety of NNC0487-0111 s.c. Once-weekly in Participants With Obesity (AMAZE 1)

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 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 84]

Вторичные конечные точки (12)

• Change in waist circumference [Срок оценки: From baseline (week 0) to week 84 and week 136]
• Change in systolic blood pressure (SBP) [Срок оценки: From baseline (week 0) to week 84 and week 136]
• Change in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) physical function score [Срок оценки: From baseline (week 0) to week 84 and week 136]
• Change in SF-36v2® Health Survey Acute (SF-36v2 Acute) physical functioning score [Срок оценки: From baseline (week 0) to week 84 and week 136]
• Change in body weight [Срок оценки: From baseline (week 0) to week 84 and week 136]
• Change in body mass index (BMI) [Срок оценки: From baseline (week 0) to week 84 and week 136]
• Change in IWQOL-Lite-CT physical composite score [Срок оценки: From baseline (week 0) to week 84 and week 136]
• Change in IWQOL-Lite-CT psychosocial composite score [Срок оценки: From baseline (week 0) to week 84 and week 136]
• Change in IWQOL-Lite-CT total score [Срок оценки: From baseline (week 0) to week 84 and week 136]
• Change in glycated haemoglobin (HbA1c) [Срок оценки: From baseline (week 0) to week 84 and week 136]
• Change in fasting plasma glucose (FPG) [Срок оценки: From baseline (week 0) to week 84 and week 136]
• Ratio to baseline: change in fasting insulin [Срок оценки: From baseline (week 0) to week 84 and week 136]

Критерии участия

Критерии включения

• Male or female (sex at birth).
• Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
• History of at least one self-reported unsuccessful dietary effort to lose body weight.

Критерии исключения

• HbA1c ≥ 6.5% (48 millimole 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 · 22 центра

• South Broward Research LLC — Miramar
• Clinical Neuroscience Solution — Orlando
• Hope Clin Res & Wellness — Conyers
• Endeavor Health — Skokie
• Midwest Inst For Clin Res — Indianapolis
• StudyMetrix Research LLC — City of Saint Peters
• New York Gastroenterology Associates — New York
• UNC Eastowne Medical Office — Chapel Hill
• … и ещё 14 центров

Великобритания · 12 центров

• Fowey River Practice — Fowey
• The Adam Practice — Poole
• Pickering Medical Practice — Pickering
• The Crouch Oak Family Practice — Addlestone
• The Health Centre — Bradford-on-Avon
• EMS Healthcare — Cheshire
• HMC Health - Heston - The Meadows Centre for Health — Hounslow
• Kiltearn Medical Centre — Nantwich
• … и ещё 4 центра

Аргентина · 6 центров

• Fundación CESIM — Santa Rosa
• Centro Medico Dra. Laura Maffei e Investigacion Clínica Apli — Buenos Aires
• Instituto de Investigaciones Clínicas Córdoba — Córdoba
• Sanatorio Esperanza — Esperanza, Santa Fe
• CIPADI — Godoy Cruz
• Instituto de Investigaciones Clinicas San Nicolás — San Nicolás

Бельгия · 6 центров

• HUB - Hôpital Erasme — Brussels
• UZA - UZ Antwerpen - Department of Endocrinology — Edegem
• Universitair Ziekenhuis Gent — Ghent
• UZ Leuven - Endocrinology — Leuven
• MECLINAS — Mechelen
• AZ Delta - Roeselare — Roeselare

Дания · 6 центров

• Sanos Clinic - Vejle — Vejle
• Sanos Clinic - Gandrup — Gandrup
• Steno Diabetes Center Nordjylland — Gistrup
• Gentofte Hospital - Center for Klinisk Metabolisk Forskning — Hellerup
• Hillerød Endokrinologisk amb. H0652 — Hillerød
• Hvidovre Hospital Endokrinologisk forsknings afsnit 159 — Hvidovre

Германия · 6 центров

• Herz- und Diabeteszentrum NRW - Bad Oeynhausen — Bad Oeynhausen
• Zentrum für klinische Studien Südbrandenburg GmbH — Elsterwerda
• MVZ im Altstadt-Carree Fulda GmbH - Zentrum für klinische Studien — Fulda
• SMO.MD GmbH - Zentrum für klinische Studien — Magdeburg
• Institut für Diabetesforschung Osnabrück — Osnabrück
• Forschungszentrum Ruhr KliFoCenter GmbH, Kahrmann — Witten

Канада · 5 центров

• C-Health Partners — Calgary
• Ocean West Research Clinic — Surrey
• G.A. Research Associates Ltd. — Moncton
• Nova Scotia Hlth Halifax — Halifax
• Milestone Research — London

Франция · 5 центров

• HOPITAL EUROPEEN GEORGES POMPIDOU_Service de nutrition et diabétologie — Paris
• HCL-HOPITAL LYON SUD_Service d'Endocrinologie-Diabète-Nutrition — Pierre-Bénite
• CHU NANTES - HOPITAL NORD LAENNEC_Service d'Endocrinologie-Diabétologie-Nutrition — Saint-Herblain
• CENTRE HOSPITALIER UNIVERSITAIRE DE TOULOUSE-HOPITAL RANGUEIL-Service de diabétologie et n — Toulouse
• CENTRE DE RECHERCHE CLINIQUE PORTES DU SUD_Service d'Endocrinologie-Diabétologie-Maladies — Vénissieux

Австралия · 4 центра

• Sydney Clinical Trials — Campbelltown
• Sydney Cardiometabolic Centre — Liverpool
• Hunter Diabetes Centre — Merewether
• Heart of Australia — Chelmer

Идентификаторы

NCT: NCT07339423 · NN9490-8021 · U1111-1313-6262 · 2024-520440-42

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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