AMAZE 1: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight Lose Weight
Purpose
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.
Condition
- Obesity
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental NNC0487-0111 |
Participants will be randomized to receive 1 out of 4 different dose levels subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity. |
|
|
Placebo Comparator Placebo |
Participants will receive placebo matched to NNC0487-0111 subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity. |
|
Recruiting Locations
South Broward Research LLC
Miramar, Florida 33027
Miramar, Florida 33027
Clinical Neuroscience Solution
Orlando, Florida 32801
Orlando, Florida 32801
Hope Clin Res & Wellness
Conyers, Georgia 30094
Conyers, Georgia 30094
Endeavor Health
Skokie, Illinois 60077
Skokie, Illinois 60077
Midwest Inst For Clin Res
Indianapolis, Indiana 46260
Indianapolis, Indiana 46260
StudyMetrix Research LLC
City of Saint Peters, Missouri 63303
City of Saint Peters, Missouri 63303
New York Gastroenterology Associates
New York, New York 10075
New York, New York 10075
UNC Eastowne Medical Office
Chapel Hill, North Carolina 27514
Chapel Hill, North Carolina 27514
PharmQuest Life Sciences LLC
Greensboro, North Carolina 27408
Greensboro, North Carolina 27408
UPA Ctr Weight and Eating Dis
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
Clinical Res Collaborative
Cumberland, Rhode Island 02864
Cumberland, Rhode Island 02864
Coastal Carolina Research Ctr
North Charleston, South Carolina 29405
North Charleston, South Carolina 29405
Hillcrest Clinical Research
Simpsonville, South Carolina 29681-1538
Simpsonville, South Carolina 29681-1538
Amarillo Medical Specialists
Amarillo, Texas 79124
Amarillo, Texas 79124
Velocity Clinical Res-Dallas
Dallas, Texas 75230-6855
Dallas, Texas 75230-6855
Care United Research, LLC
Forney, Texas 75126
Forney, Texas 75126
Washington Cntr Weight Mgmt
Arlington, Virginia 22206
Arlington, Virginia 22206
Health Res of Hampton Roads
Newport News, Virginia 23606
Newport News, Virginia 23606
Selma Medical Associates
Winchester, Virginia 22601-3834
Winchester, Virginia 22601-3834
Rainier Clin Res Ctr Inc
Renton, Washington 98057
Renton, Washington 98057
More Details
- Status
- Recruiting
- Sponsor
- Novo Nordisk A/S