NNC0487-0111 for weight loss and sleep apnea in adults with obesity and OSA on PAP

Is this trial a fit for you?

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 randomized, double-blind, placebo-controlled phase 3 trial evaluating the safety and effectiveness of NNC0487-0111 given as weekly injections for people with overweight/obesity and obstructive sleep apnea treated with positive airway pressure. Participants are randomly assigned to receive either NNC0487-0111 or a matched placebo over a set period. The study will monitor weight change, sleep apnea measures, and safety signals to determine overall benefit. Key eligibility includes adults 18+ with obesity or overweight and moderate-to-severe OSA (AHI ≥ 15). Exclusion criteria include diabetes, recent related surgeries, certain craniofacial conditions, and prior GLP-1–related therapies.

Why it matters

Who can join: the full rules

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

• Dignity Health, Mercy Gilbert
  Gilbert, Arizona, United States Recruiting
• DM Clinical
  Bradenton, Florida, United States Recruiting
• Essence MD Research
  Naples, Florida, United States Recruiting
• Palm Beach Research Center
  West Palm Beach, Florida, United States Recruiting
• NeuroTrials Research, Inc.
  Atlanta, Georgia, United States Recruiting
• Physicians Research Associates
  Lawrenceville, Georgia, United States Recruiting

+42 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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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.