Recruiting

Phase 3

NNC0487-0111AMAZE 3: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Obstructive Sleep Apnoea Not Treated With Positive Airway Pressure Lose Weight and Improve Sleep Apnoea

Sponsor:

Novo Nordisk A/S

Code:

NCT07571005

Conditions

Obesity

Overweight

Obstructive Sleep Apnoea

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

NNC0487-0111

Placebo (matched to NNC0487-0111)

Study Details

Brief summary:

This study is being done to look at the efficacy and safety of NNC0487-0111 in participants with excess body weight and obstructive sleep apnoea not treated with positive airway pressure lose weight and improve sleep apnoea. 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) and which treatment participants get is decided by chance.

Conditions

Obesity

Overweight

Obstructive Sleep Apnoea

Study ID

NCT07571005

Start date

May 5, 2026

Status verified date

Jul, 2026

Completion date

Oct 4, 2028

Anticipated

Primary completion date

Jul 12, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Key Inclusion Criteria:

Male or female (sex at birth)
Age 18 years or above at the time of signing informed consent
Previously diagnosed moderate-to-severe OSA with an AHI ≥ 15, as diagnosed with polysomnography (PSG), home sleep apnoea test (HSAT), or other method that meets local guidelines prior to screening

Key Exclusion Criteria:

Glycated haemoglobin (HbA1c) ≥ 6.5% (48 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
Any planned or previous surgery within 90 days prior to screening for sleep apnoea, including septoplasty, turbinoplasty, or other ear, nose, and throat surgeries, including tonsillectomy and adenoidectomy
Significant craniofacial abnormalities that may affect breathing at baseline, for example Treacher Collins syndrome and Pierre Robin Sequence
Treatment with glucagon-like-peptide-1 (GLP-1) receptor agonist (RA), dual GLP-1/gastric inhibitory peptide (GIP) RAs (or any other GLP-1 based treatment) or amylin analogues before screening

Study Design

Enrollment

300 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 of the 2 dose levels of NNC0487-0111 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 80) ]
Change in apnoea-hypopnoea index (AHI) [ Time Frame: From baseline (week 0) to (week 80) ]

Central Contacts and Locations

Central contacts

Novo Nordisk

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

Locations

Artemis Insitute for Clin Res

Recruiting

San Diego, California, United States, 92123

PharmaDev Clinical Research Institute LLC

Recruiting

Miami, Florida, United States, 33176

Renstar Medical Research

Recruiting

Ocala, Florida, United States, 34470

Conquest Research

Recruiting

Atlanta, Georgia, United States, 30328

Physicians Research Associates

Recruiting

Lawrenceville, Georgia, United States, 30046

University Of Chicago

Recruiting

Chicago, Illinois, United States, 60637

Weil Cornell Medicine

Recruiting

New York, New York, United States, 10021

CTI Clinical Research Center

Recruiting

Cincinnati, Ohio, United States, 45212

Epic Medical Research

Recruiting

DeSoto, Texas, United States, 75115

Advanced Neurology Epilepsy and Sleep Center ANESC

Recruiting

El Paso, Texas, United States, 79912

Biorhythms Center for Integrative Sleep Medicine

Recruiting

El Paso, Texas, United States, 79912

Houston Pulmonary Medicine Associates, PA and Research Physicians Network, LLC

Recruiting

Houston, Texas, United States, 77089

Sleep Therapy Research Center

Recruiting

San Antonio, Texas, United States, 78229

Tricoastal Sleep Center

Recruiting

Sugar Land, Texas, United States, 77478

Rainier Clin Res Ctr Inc

Recruiting

Renton, Washington, United States, 98057

More Information

Sponsor

Novo Nordisk A/S

Last update posted

Jul 13, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Novo Nordisk A/S on 2026-07-13.