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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 trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 1 step.

  1. Step 1

    Study participation and treatment

    Participation begins with the administration of either the test medicine, known as zenagamtide, or a placebo, which is an inactive substance. the test medicine is provided as a solution for injection in a pre-filled pen.

    The injection is administered subcutaneously, which means it is injected into the fatty tissue just under the skin.

    The medication is administered once weekly.

Who can join the trial?

8 criteria

  • 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 trial?

5 criteria

  • 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.
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Investigated drugs

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.

What is already known about the treatment

Zenagamtide - This medication is an experimental weight-management drug administered as a solution for injection through a pre-filled pen under the skin. Currently being studied in clinical trials, it is primarily intended to help individuals manage overweight, obesity, and sleep apnea. It works as a hormone-based therapy by mimicking natural signals in the body to regulate appetite and metabolism at a molecular level.

Investigated diseases

  • 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 detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-520443-16-00Protocol codeNN9490-8293Estimated enrolment300 patientsSponsorNovo Nordisk A/S

sourced from the EU Clinical Trials Register and site verification

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