Amazing weight loss and sleep apnea treatment with NNC0487-0111
Official title: Efficacy and Safety of NNC0487-0111 s.c. Once-weekly in Participants With Overweight or Obesity, and Obstructive Sleep Apnoea Not Treated With Positive Airway Pressure (AMAZE 3)
Run by Novo Nordisk A/S · NCT07571005 · Data updated 2026-11-12
This study tests whether weekly injections of NNC0487-0111 help adults with overweight or obesity and sleep apnea who aren’t using CPAP to lose weight and improve breathing during sleep.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | Novo Nordisk A/S Industry-sponsored |
| Locations | 80 sites (San Diego, California and 79 other locations) |
| Status | Recruiting |
| Started | May 5, 2026 |
| Main results expected | July 12, 2028 |
| Study ends | October 4, 2028 |
| Registry record updated | September 11, 2026 |
| Trial ID | NCT07571005 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 years or older with overweight or obesity and moderate-to-severe obstructive sleep apnea not treated with CPAP.
✕Probably not a fit
Participants with certain medical conditions (e.g., diabetes, recent ENT surgery) or who do not respond to the treatment may not see a benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a Phase 3, randomized, double-blind, placebo-controlled trial evaluating the safety and efficacy of NNC0487-0111 in adults with excess weight and obstructive sleep apnea not treated with positive airway pressure. Participants receive either NNC0487-0111 or a matched placebo by subcutaneous injection once a week for a specified period. The study compares weight loss and sleep apnea outcomes between groups, while monitoring safety and tolerability. Key eligibility includes adults with BMI indicating overweight/obesity and an AHI of 15 or higher, with several exclusions such as diabetes and recent ENT surgery. Conducted at multiple sites, the trial aims to determine if this medicine can provide meaningful benefits beyond current options.
Why it matters
Potential benefit: If successful, participants might lose weight and experience better sleep apnea control.
How similar studies have gone: Prior similar approaches have shown promise in weight management and sleep apnea, but this exact regimen is being tested in a Phase 3 trial.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Artemis Insitute for Clin Res
San Diego, California, United States Recruiting -
PharmaDev Clinical Research Institute LLC
Miami, Florida, United States Recruiting -
Renstar Medical Research
Ocala, Florida, United States Recruiting -
Conquest Research
Atlanta, Georgia, United States Recruiting -
Physicians Research Associates
Lawrenceville, Georgia, United States Recruiting -
University Of Chicago
Chicago, Illinois, United States Recruiting
Show 44 more locations
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Weil Cornell Medicine
New York, New York, United States Recruiting -
CTI Clinical Research Center
Cincinnati, Ohio, United States Recruiting -
Epic Medical Research
DeSoto, Texas, United States Recruiting -
Advanced Neurology Epilepsy and Sleep Center ANESC
El Paso, Texas, United States Recruiting -
Biorhythms Center for Integrative Sleep Medicine
El Paso, Texas, United States Recruiting -
Houston Pulm Med Res Network
Houston, Texas, United States Recruiting -
Sleep Therapy Research Center
San Antonio, Texas, United States Recruiting -
Tricoastal Sleep Center
Sugar Land, Texas, United States Recruiting -
Rainier Clin Res Ctr Inc
Renton, Washington, United States Recruiting -
Woolcock Institute
Macquarie Park, New South Wales, Australia Recruiting -
University of Sunshine Coast - Vitality Village
Birtinya, Queensland, Australia Recruiting -
Nightingale Research Adelaide
Adelaide, South Australia, Australia Recruiting -
University of Western Australia - Centre for Sleep Science
Crawley, Western Australia, Australia Recruiting -
Peking University People's Hospital-Endocrinology
Beijing, Beijing Municipality, China Recruiting -
The Second Affiliated Hospital of Nanjing Medical University-Endocrinology
Nanjing, Jiangsu, China Recruiting -
The First Affiliated Hospital of Soochow University-Endocrinology
Suzhou, Jiangsu, China Recruiting -
The Affiliated Hospital of Jiangsu University-Endocrinology
Zhenjiang, Jiangsu, China Recruiting -
Huzhou Central Hospital-Endocrinology
Huzhou, Zhejiang, China Recruiting -
Regionshospitalet Gødstrup, Øre-næse-hals-kirurgisk
Herning, Denmark Recruiting -
Sjællands Universitetshospital, Køge - Øre-Næse-Hals afdeling
Køge, Denmark Recruiting -
Siteworks GmbH Bochum
Bochum, Germany Recruiting -
Wendisch - Dahl Hamburg - DZHW
Hamburg, Germany Recruiting -
Siteworks GmbH Hannover
Hanover, Germany Recruiting -
Siteworks GmbH Karlsruhe
Karlsruhe, Germany Recruiting -
Institut für Diabetesforschung GmbH Münster - Dr. med. Rose
Münster, Germany Recruiting -
Siteworks GmbH - Prüfzentrum Schleswig | RespiRatio
Schleswig, Germany Recruiting -
Government Siddhartha Medical College & Government General Hospital, Vijayawada
Vijayawada, Andhra Pradesh, India Recruiting -
Rajarajeswari Medical College and Hospital
Bengaluru, Karnataka, India Recruiting -
Amrita Institute Of Medical Sciences & Research Centre
Kochi, Kerala, India Recruiting -
Bhaktivedanta Hospital & Research Institute
Mumbai, Maharashtra, India Recruiting -
Asian Kidney Hospital And Medical Centre
Nagpur, Maharashtra, India Recruiting -
Midland Healthcare & Research Center
Lucknow, Uttar Pradesh, India Recruiting -
Apollo Multispeciality Hospital, Kolkata
Kolkata, West Bengal, India Recruiting -
Asthma Bhawan
Jaipur, India Recruiting -
Vardhaman Mahavir Medical College & Safdarjung Hospital
New Delhi, India Recruiting -
4 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej We Wroclawiu
Wroclaw, Dolnoslaskie Voivodeship, Poland Recruiting -
Uniwersyteckie Centrum Kliniczne
Gdansk, Poland Recruiting -
Penta Hospitals Badania Kliniczne Sp. z o.o.
Gdansk, Poland Recruiting -
5 Wojskowy Szpital Kliniczny z Polikliniką-Samodzielny Publiczny Zakład Opieki Zdrowotnej w Krakowie
Krakow, Poland Recruiting -
Uniwersytecki Szpital Kliniczny W Poznaniu
Poznan, Poland Recruiting -
Gyncentrum Sp. z o. o.
Warsaw, Poland Recruiting -
National Institute Of Tuberculosis And Lung Diseases - Instytut Gruźlicy i Chorób Płuc
Warsaw, Poland Recruiting -
PANSTWOWY INSTYTUT MEDYCZNY MSWiA
Warsaw, Poland Recruiting -
ETG Warszawa Sp. z o.o.
Warsaw, Poland Recruiting
+30 more sites. See ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Novo Nordisk
- Email: clinicaltrials@novonordisk.com
- Phone: (+1) 866-867-7178
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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NNC0487-0111 for weight loss and sleep apnea in adults with obesity and OSA on PAP
A phase 3 study will test whether the medicine NNC0487-0111 helps adults who are overweight or have obesity and treated sleep apnea lose weight and improve sleep apnea symptoms compared with placebo.
-
Berobenatide for knee pain in adults who are overweight or with obesity
This study tests berobenatide vs. placebo to see if it reduces knee pain and improves function while helping with weight in adults with knee osteoarthritis and overweight/obesity.
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Maridebart cafraglutide in people who switched from weekly GLP-1 receptor agonists
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EloraTZP for weight loss in adults with overweight/obesity and type 2 diabetes
This trial tests whether a coformulation of eloralintide and tirzepatide helps people with obesity or overweight and type 2 diabetes lose weight compared with tirzepatide alone.
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Monthly dose of PF-08653944 vs placebo in Chinese adults who are overweight or obese
This study tests whether berobenatide (PF-08653944) given once a month helps adults in China lose weight compared with a placebo.
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FutureShape Family: a family-based weight-management program with semaglutide for children and parents
This trial tests whether a family-centered program that combines a prescription medication (semaglutide) with lifestyle support and app-based coaching can help adults with obesity and their children who are overweight/obese.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.