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A study to evaluate the effects of zenagamtide in people with overweight or obesity and obstructive sleep apnoea not treated with positive airway pressure

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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 investigate the effectiveness and safety of a new medication in people living with overweight or obesity and obstructive sleep apnoea. Obstructive sleep apnoea is a condition where breathing repeatedly stops and starts during sleep. This research specifically focuses on individuals who are not currently using positive airway pressure, a common treatment that uses a machine to help keep airways open during sleep.

The treatment being studied is called NNC0487-0111, which contains the active substance zenagamtide. This medication is administered via subcutaneous injection, which means it is injected into the fatty tissue just under the skin, using a pre-filled pen. Participants in the study will receive either NNC0487-0111 or a placebo once a week.

During the study, changes in body weight and the apnoea-hypopnoea index will be monitored. The apnoea-hypopnoea index is a measurement used to track how many times a person stops breathing or has shallow breathing during a sleep period. Other factors such as body mass index, which relates weight to height, and various health markers including blood pressure and cholesterol levels, may also be observed over the course of the trial.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Participation in the study

    You will receive either a test medicine called zenagamtide or a placebo, which is a substance that does not contain active medication.

    The test medicine is provided as a solution for injection in a pre-filled pen and is administered subcutaneously, which means it is injected just under the skin.

  2. Step 2

    Medication administration

    The test medicine or the placebo is administered once weekly.

Who can join the trial?

7 criteria

  • You must be a **male** or **female** (the sex assigned to you at birth).
  • You must be **18 years of age or older** when you sign the agreement to join the study.
  • You must be **overweight** or have **obesity** (having a high amount of body fat).
  • You must have been diagnosed with **moderate-to-severe obstructive sleep apnoea (OSA)**, which is a condition where your breathing repeatedly stops and starts while you sleep.
  • Your diagnosis of sleep apnoea must include an **apnoea-hypopnoea index (AHI)** of 15 or higher. This number represents the average number of times your breathing stops or becomes very shallow during each hour of sleep.
  • Your sleep condition must have been confirmed using a **polysomnography (PSG)**, which is a formal sleep study conducted in a lab, a **home sleep apnoea test (HSAT)**, or another approved medical test.
  • You must **not** be currently using **positive airway pressure (PAP)**, which is a type of medical machine (like a CPAP) used to keep your airways open while you sleep.

Who cannot join the trial?

5 criteria

  • You cannot participate if your glycated haemoglobin, which is a test that shows your average blood sugar levels over the past few months, is 6.5% or higher.
  • You cannot participate if you have a history of type 1 or type 2 diabetes mellitus, which are conditions where the body cannot properly control blood sugar levels.
  • You cannot participate if you have had or are planning to have any surgery related to the ear, nose, or throat within the last 90 days, such as septoplasty (surgery to fix a deviated septum in the nose), turbinoplasty (surgery to reduce swelling in the nasal passages), tonsillectomy (removal of the tonsils), or adenoidectomy (removal of the adenoids).
  • You cannot participate if you have significant craniofacial abnormalities, which are physical differences in the structure of the skull or face that might make it harder to breathe.
  • You cannot participate if you have previously used or are currently using glucagon-like-peptide-1 (GLP-1) receptor agonists, dual GLP-1/gastric inhibitory peptide (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 that is given as an injection under the skin. In this study, it is being tested to see if it can help people who are overweight or have obesity and also suffer from obstructive sleep apnea to reduce their body weight and improve their breathing during sleep.

What is already known about the treatment

Zenagamtide - This medication is an experimental drug provided as a solution for injection in a pre-filled pen and is administered once a week through a needle under the skin. Currently being studied in clinical trials, it is being investigated for its ability to help manage weight in people who are overweight or obese and also suffer from obstructive sleep apnea. It belongs to a class of drugs that works by mimicking natural hormones in the body to regulate hunger and metabolism at a molecular level.

Investigated diseases

Obesity - This is a condition where an individual accumulates excessive amounts of body fat. It often develops over time due to an imbalance between energy intake from food and energy expenditure through physical activity. As the condition progresses, it can lead to increased body mass index and changes in body composition. Obstructive sleep apnoea - This is a sleep disorder characterized by repeated interruptions in breathing during sleep. These interruptions occur because the muscles in the throat relax too much, causing the airway to narrow or close completely. This leads to periods where breathing stops or becomes very shallow, often occurring many times throughout the night.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-520442-36-00Protocol codeNN9490-8025Estimated enrolment300 patientsSponsorNovo Nordisk A/S

sourced from the EU Clinical Trials Register and site verification

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