Recruiting
Phase 3

NNC0487-0111

Sponsor:

Novo Nordisk A/S

Code:

NCT07571109

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 overweight or obesity, and obstructive sleep apnoea treated with positive airway pressure. 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

NCT07571109

Start date

May 5, 2026

Status verified date

Aug, 2026

Completion date

Aug 21, 2028

Anticipated

Primary completion date

Jun 26, 2028

Anticipated

Eligibility Criteria

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) 866-867-7178clinicaltrials@novonordisk.com

Locations

Dignity Health, Mercy Gilbert

Recruiting

Gilbert, Arizona, United States, 85297

DM Clinical

Recruiting

Bradenton, Florida, United States, 34209

Essence MD Research

Recruiting

Naples, Florida, United States, 34102

Palm Beach Research Center

Recruiting

West Palm Beach, Florida, United States, 33409

NeuroTrials Research, Inc.

Recruiting

Atlanta, Georgia, United States, 30328

Physicians Research Associates

Recruiting

Lawrenceville, Georgia, United States, 30046

Chicago Research Center, Inc

Recruiting

Chicago, Illinois, United States, 60634

Weil Cornell Medicine

Recruiting

New York, New York, United States, 10021

Lillestol Research LLC

Recruiting

Fargo, North Dakota, United States, 58104

CTI Clinical Research Center

Recruiting

Cincinnati, Ohio, United States, 45212

Bogan Sleep Consultants, LLC

Recruiting

Columbia, South Carolina, United States, 29201

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 Pulm Med Res Network

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

Seattle Clinical Research Center

Recruiting

Seattle, Washington, United States, 98104

More Information

Sponsor

Novo Nordisk A/S

Last update posted

Aug 4, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Novo Nordisk A/S on 2026-08-04.