Recruiting

Phase 3

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

Sponsor:

Novo Nordisk A/S

Code:

NCT07339423

Conditions

Obesity

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

NNC0487-0111

Placebo (matched to NNC0487-0111)

Study Details

Brief summary:

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.

Conditions

Obesity

Study ID

NCT07339423

Start date

Feb 24, 2026

Status verified date

Jul, 2026

Completion date

Aug 21, 2029

Anticipated

Primary completion date

Jun 26, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

1150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

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.

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 measure

Relative change in body weight [ Time Frame: From baseline (week 0) to week 84 ]

Central Contacts and Locations

Central contacts

Novo Nordisk

(+1) 866-867-7178 clinicaltrials@novonordisk.com

Locations

South Broward Research LLC

Recruiting

Miramar, Florida, United States, 33027

Clinical Neuroscience Solution

Recruiting

Orlando, Florida, United States, 32801

Hope Clin Res & Wellness

Recruiting

Conyers, Georgia, United States, 30094

Endeavor Health

Recruiting

Skokie, Illinois, United States, 60077

Midwest Inst For Clin Res

Recruiting

Indianapolis, Indiana, United States, 46260

StudyMetrix Research LLC

Recruiting

City of Saint Peters, Missouri, United States, 63303

New York Gastroenterology Associates

Recruiting

New York, New York, United States, 10075

UNC Eastowne Medical Office

Recruiting

Chapel Hill, North Carolina, United States, 27514

PharmQuest Life Sciences LLC

Recruiting

Greensboro, North Carolina, United States, 27408

Accellacare and KDCILM, LLC

Recruiting

Wilmington, North Carolina, United States, 28401

UPA Ctr Weight and Eating Dis

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Clinical Res Collaborative

Recruiting

Cumberland, Rhode Island, United States, 02864

Medical Uni of SC Charleston

Recruiting

Charleston, South Carolina, United States, 29425

Coastal Carolina Research Ctr

Recruiting

North Charleston, South Carolina, United States, 29405

Hillcrest Clinical Research

Recruiting

Simpsonville, South Carolina, United States, 29681-1538

Amarillo Medical Specialists

Recruiting

Amarillo, Texas, United States, 79124

Velocity Clinical Res-Dallas

Recruiting

Dallas, Texas, United States, 75230-6855

Care United Research, LLC

Recruiting

Forney, Texas, United States, 75126

Washington Cntr Weight Mgmt

Recruiting

Arlington, Virginia, United States, 22206

Health Res of Hampton Roads

Recruiting

Newport News, Virginia, United States, 23606

Selma Medical Associates

Recruiting

Winchester, Virginia, United States, 22601-3834

Rainier Clin Res Ctr Inc

Recruiting

Renton, Washington, United States, 98057

C-Health Partners

Recruiting

Calgary, Alberta, Canada, T2V 4J2

Ocean West Research Clinic

Recruiting

Surrey, British Columbia, Canada, V3Z 2N6

G.A. Research Associates Ltd.

Recruiting

Moncton, New Brunswick, Canada, E1G 1A7

Nova Scotia Hlth Halifax

Recruiting

Halifax, Nova Scotia, Canada, B3H1V7

Milestone Research

Recruiting

London, Ontario, Canada, N5W 6A2

More Information

Sponsor

Novo Nordisk A/S

Last update posted

Jul 9, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-14. This information was provided to ClinicalTrials.gov by Novo Nordisk A/S on 2026-07-09.