Study of zenagamtide for weight loss and sleep improvement in patients with obesity and obstructive sleep apnea using positive airway pressure therapy

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What is this study about?

This study aims to evaluate the effectiveness and safety of the drug NNC0487-0111, also known as zenagamtide, in individuals living with overweight or obesity and obstructive sleep apnoea. Obstructive sleep apnoea is a condition where breathing repeatedly stops and starts during sleep. Participants in this study are already using positive airway pressure, which is a type of therapy that uses a machine to provide a steady stream of air through a mask to keep the airways open during sleep.

During the study, participants will receive either zenagamtide or a placebo via a subcutaneous injection, which means the medicine is delivered through a small needle just under the skin. The injections are administered once a week using a pre-filled pen. The study will monitor changes in body weight and the apnoea-hypopnoea index, which is a measurement used to track how many times breathing is interrupted or becomes shallow during sleep. Other aspects being observed include changes in sleep quality, blood pressure, and various blood markers.

Who Can Join the Study?

  • You must be a male or female (the sex you were assigned at birth).
  • You must be 18 years of age or older when you sign the consent form to join the study.
  • You must have overweight or obesity, which means having a high amount of body fat.
  • You must have obstructive sleep apnoea, a condition where your breathing repeatedly stops and starts while you sleep.
  • You must be using positive airway pressure (PAP) therapy, which is a treatment that uses a machine to provide air pressure through a mask to keep your airways open during sleep.
  • You must have been previously diagnosed with moderate-to-severe obstructive sleep apnoea.
  • Your apnoea-hypopnoea index (AHI), which is a measurement of how many times your breathing stops or becomes very shallow per hour, must be 15 or higher.
  • Your sleep condition must have been confirmed by a polysomnography (PSG), which is a detailed sleep study performed in a lab, a home sleep apnoea test (HSAT), or another approved testing method.

Who Cannot Join the Study?

  • Your glycated haemoglobin (HbA1c), which is a blood test that shows your average blood sugar levels over the past few months, must be 6.5% or higher.
  • You have a history of type 1 or type 2 diabetes mellitus, which are conditions where your body cannot properly control the amount of sugar in your blood.
  • You have had or are planning to have any surgery related to breathing or the ears, nose, and throat (such as procedures on the nose, ears, tonsils, or adenoids) within the 90 days before the study begins.
  • You have craniofacial abnormalities, which are physical differences in the structure of the skull or face that could make it difficult to breathe normally.
  • You are currently using or have recently used GLP-1 receptor agonists, dual GLP-1/GIP RAs, or amylin analogues, which are specific types of medications used to help manage blood sugar or weight.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Hospital Universitari De Santa Maria Lleida Spain
Siteworks GmbH Hanover Germany
Etg Neuroscience Sp. z o.o. Warsaw Poland
Hospital Universitario Quironsalud Madrid Pozuelo De Alarcon Spain
Uniwersytecki Szpital Kliniczny W Poznaniu Poznan Poland
Institut fuer Diabetesforschung Muenster GmbH Munster Germany
Nzymjpue Iewavvqax Ov Tqaxkgvzcltg Aqv Ljvn Deqksgqv Warsaw Poland
Coaxsbs Boknb Kmxkndtdkrt Phoaorxn Smr z oykd Gdansk Poland
Atfbmeofpc Imojhpwma Dj Iealrhvwklrjz Subkrbjny Boypacqq Vitoria Spain
5 Wmfcczpz Sjivnab Kjgjegkoz Z Puhwbdqislp Sinxwpjosst Phbayvopc Zfniwf Oquxuz Ztimiwkntr W Kiioykpi Cracow Poland
Pnthuseze Ilpsczrm Mkdllntn Mfmmckksthsz Sczot Wtxkcmdjuclp I Asvekbknlodvz Warsaw Poland
Utmxxfgsasklfr Cccdfyi Kojmvhiqv Gdansk Poland
Hrhgjqih Vktw dmcsdacq Barcelona Spain
Pdcauxefqurji Dd Ujclbn Wfxcdssr Dk Ducxgbi Dcng Uqv Pcpv Dz Jopl Aztyyr Hamburg Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Germany Germany
Recruiting
20.04.2026
Poland Poland
Recruiting
20.04.2026
Spain Spain
Recruiting
20.04.2026

Trial locations

Zenagamtide is an experimental medication administered via a skin injection to help study its effects on body weight and breathing during sleep in people who are overweight or have obesity and obstructive sleep apnoea.

Obesity – This condition occurs when an individual has accumulated excessive amounts of body fat. It is often characterized by a high body mass index relative to height. The condition can develop gradually due to an imbalance between energy intake and energy expenditure. As it progresses, it may lead to various metabolic changes in the body.

Obstructive sleep apnoea – This is a sleep disorder where breathing repeatedly stops and starts during sleep. It is caused by the physical blockage of the airway in the throat. These interruptions in breathing can range from mild to severe. Over time, the frequent pauses in breathing can significantly impact the quality of sleep and oxygen levels in the blood.

Trial ID:
2024-520443-16-00
Protocol code:
NN9490-8293
Trial Phase:
Therapeutic confirmatory (Phase III)

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