AMAZE 1: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight Lose Weight
Phase 3 – large-scale trial before approval
Conditions:
Obesity
Sponsor: Novo Nordisk A/S
trial.available_in:
БГ
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.
Who can participate
Key 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.
Key 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.
Locations
8
Argentina (1)
Fundación CESIM
Santa Rosa , La Pampa Province
NOT_YET_RECRUITING
Australia (1)
Sydney Clinical Trials
Campbelltown , New South Wales
NOT_YET_RECRUITING
Belgium (1)
HUB - Hôpital Erasme
Brussels
NOT_YET_RECRUITING
Canada (1)
C-Health Partners
Calgary , Alberta
NOT_YET_RECRUITING
Denmark (1)
Sanos Clinic - Vejle
Vejle , Region Syddanmark
NOT_YET_RECRUITING
France (1)
HOPITAL EUROPEEN GEORGES POMPIDOU_Service de nutrition et diabétologie