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Recruiting NCT07339423

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

Phase III Interventional Obesity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: NNC0487-0111, Placebo (matched to NNC0487-0111).
Who it may be relevant to
Registry conditions: Obesity. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Argentina, Australia, Belgium, Canada +4
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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 84]
Secondary outcome measures (12)
  • Change in waist circumference [Time frame: From baseline (week 0) to week 84 and week 136]
  • Change in systolic blood pressure (SBP) [Time frame: 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 [Time frame: From baseline (week 0) to week 84 and week 136]
  • Change in SF-36v2® Health Survey Acute (SF-36v2 Acute) physical functioning score [Time frame: From baseline (week 0) to week 84 and week 136]
  • Change in body weight [Time frame: From baseline (week 0) to week 84 and week 136]
  • Change in body mass index (BMI) [Time frame: From baseline (week 0) to week 84 and week 136]
  • Change in IWQOL-Lite-CT physical composite score [Time frame: From baseline (week 0) to week 84 and week 136]
  • Change in IWQOL-Lite-CT psychosocial composite score [Time frame: From baseline (week 0) to week 84 and week 136]
  • Change in IWQOL-Lite-CT total score [Time frame: From baseline (week 0) to week 84 and week 136]
  • Change in glycated haemoglobin (HbA1c) [Time frame: From baseline (week 0) to week 84 and week 136]
  • Change in fasting plasma glucose (FPG) [Time frame: From baseline (week 0) to week 84 and week 136]
  • Ratio to baseline: change in fasting insulin [Time frame: From baseline (week 0) to week 84 and week 136]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

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 · 22 centers
  • 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
  • … and 14 more centers
United Kingdom · 12 centers
  • 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
  • … and 4 more centers
Argentina · 6 centers
  • 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
Belgium · 6 centers
  • 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
Denmark · 6 centers
  • 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
Germany · 6 centers
  • 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
Canada · 5 centers
  • C-Health Partners — Calgary
  • Ocean West Research Clinic — Surrey
  • G.A. Research Associates Ltd. — Moncton
  • Nova Scotia Hlth Halifax — Halifax
  • Milestone Research — London
France · 5 centers
  • 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
Australia · 4 centers
  • Sydney Clinical Trials — Campbelltown
  • Sydney Cardiometabolic Centre — Liverpool
  • Hunter Diabetes Centre — Merewether
  • Heart of Australia — Chelmer

Identifiers

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

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗