RecruitingPhase 3interventionalRules rewrite

Phase 3: testing NNC0487-0111 for Obesity

This study is being done to look at the how well it works 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.

Official registry: https://clinicaltrials.gov/study/NCT07571109 · Novo Nordisk A/S · enrollment listed as 300

What this phase means

Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are NNC0487-0111, or Placebo (matched to NNC0487-0111). The registry lists allocation as randomized. This study is being done to look at the how well it works and safety of NNC0487-0111 in participants with overweight or obesity, and obstructive sleep apnoea treated with positive airway pressure.

They plan to enroll about 300 people at 92 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

Efficacy and Safety of NNC0487-0111 s.c. Once-weekly in Participants With Overweight or Obesity, and Obstructive Sleep Apnoea Treated With Positive Airway Pressure (AMAZE 4)

Interventions: NNC0487-0111, Placebo (matched to NNC0487-0111)

Primary outcome (registry wording): Relative change in body weight

Who it is for (from inclusion criteria)

Ages 18 Years to any
Male or female (sex at birth)
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

Who the registry excludes

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

Public study contact (from the registry)

Novo Nordisk

(+1) 866-867-7178

clinicaltrials@novonordisk.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

92 listed

Dignity Health, Mercy Gilbert — Gilbert, Arizona (recruiting)
DM Clinical — Bradenton, Florida (recruiting)
Essence MD Research — Naples, Florida (recruiting)
Palm Beach Research Center — West Palm Beach, Florida (recruiting)
NeuroTrials Research, Inc. — Atlanta, Georgia (recruiting)
Physicians Research Associates — Lawrenceville, Georgia (recruiting)
Chicago Research Center, Inc — Chicago, Illinois (recruiting)
Weil Cornell Medicine — New York, New York (recruiting)
Lillestol Research LLC — Fargo, North Dakota (recruiting)
CTI Clinical Research Center — Cincinnati, Ohio (recruiting)
Clinical Research Associates of Central PA, LLC — DuBois, Pennsylvania (not_yet_recruiting)
Bogan Sleep Consultants, LLC — Columbia, South Carolina (recruiting)

+ 72 sites outside the US on the same record

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FAQ about this NCT record

Is NCT07571109 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07571109?

Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07571109?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary