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

NCT07339423

RecruitingPhase 3

Sponsor: Novo Nordisk A/S

Conditions: Obesity

Interventions: NNC0487-0111, Placebo (matched to NNC0487-0111)

Countries: United States, Argentina, Australia, Belgium, Canada, Denmark, France, Germany

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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 (72)
  • Miramar, Florida, United States
  • Orlando, Florida, United States
  • Conyers, Georgia, United States
  • Skokie, Illinois, United States
  • Indianapolis, Indiana, United States
  • City of Saint Peters, Missouri, United States
  • New York, New York, United States
  • Chapel Hill, North Carolina, United States
  • Greensboro, North Carolina, United States
  • Wilmington, North Carolina, United States
  • Philadelphia, Pennsylvania, United States
  • Cumberland, Rhode Island, United States
  • Charleston, South Carolina, United States
  • North Charleston, South Carolina, United States
  • Simpsonville, South Carolina, United States
  • Amarillo, Texas, United States
  • Dallas, Texas, United States
  • Forney, Texas, United States
  • Arlington, Virginia, United States
  • Newport News, Virginia, United States
  • Winchester, Virginia, United States
  • Renton, Washington, United States
  • Santa Rosa, La Pampa Province, Argentina
  • Buenos Aires, Argentina
  • Córdoba, Argentina
  • Esperanza, Santa Fe, Argentina
  • Godoy Cruz, Argentina
  • San Nicolás, Argentina
  • Campbelltown, New South Wales, Australia
  • Liverpool, New South Wales, Australia
  • + 42 more on CT.gov