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Study of Maridebart Cafraglutide for Adults with Obstructive Sleep Apnea and Overweight or Obesity Who Use 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 investigates a treatment for adults living with Obstructive Sleep Apnea, a condition where breathing repeatedly stops and starts during sleep, specifically in those who also live with overweight or obesity. The participants in this study are already using Positive Airway Pressure therapy, which is a device that uses air pressure to keep the airways open during sleep. The goal of the study is to evaluate the effectiveness and safety of the drug AMG 133, also known as maridebart cafraglutide, compared to a placebo.

During the study, participants will receive either maridebart cafraglutide or a placebo through a subcutaneous injection, which means the medicine is administered just under the skin. The study will monitor changes in the Apnea-Hypopnea Index, an assessment used to measure the severity of breathing interruptions during sleep. Other factors being observed include body weight and levels of C-reactive protein, which is a substance in the blood that can indicate inflammation in the body.

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

    Study participation

    After joining the study, a subcutaneous injection (an injection under the skin) of either maridebart cafraglutide or a placebo (a substance with no active medicine) is administered.

    The medication is provided as a solution for injection.

  2. Step 2

    Treatment period

    The treatment continues for a period of 52 weeks.

    During this time, the apnea-hypopnea index (a measure of how many times breathing stops or becomes shallow during sleep) is monitored to evaluate the effect of the medication.

Who can join the trial?

8 criteria

  • You must be at least 18 years old or the legal age required in your country.
  • You must give your informed consent, which means you agree to participate after being told all the details of the study.
  • You must have a medical history of moderate to severe obstructive sleep apnea (OSA), which is a condition where your breathing repeatedly stops and starts while you sleep.
  • Your Apnea-Hypopnea Index (AHI) must be 15 or higher. This index is a measurement of how many times your breathing becomes shallow or stops every hour you sleep.
  • The measurement of your breathing issues must be confirmed using a polysomnography (PSG), which is a sleep study that monitors your body's functions while you sleep, or a home sleep apnea test (HSAT), which is a test performed in your own bed.
  • Your Body Mass Index (BMI) must be 27 or higher. BMI is a calculation used to determine if a person is at a healthy weight based on their height and weight.
  • You must have a history of trying to lose weight through diet and exercise at least once without success.
  • You must have been using PAP therapy (pressure from a machine that helps keep your airways open during sleep) for at least 3 months in a row and plan to keep using it during the study.

Who cannot join the trial?

14 criteria

  • You have had or are planning to have surgery on your upper throat or airway to treat sleep apnea, or any major surgery on your ears, nose, or throat.
  • You have had or are planning to have any surgical, endoscopic (using a small camera to look inside the body), or device-based treatments to manage obesity (being significantly overweight).
  • You have Diabetes Mellitus (a condition where blood sugar levels are too high), including Type 1 or Type 2, or a history of ketoacidosis or hyperosmolar state (serious complications where blood sugar and chemicals in the blood reach dangerous levels).
  • You have a history of medical, behavioral, or psychiatric (mental health) disorders that cause insomnia (trouble sleeping) or excessive sleepiness, other than sleep apnea.
  • You have had malignancy (cancer) within the last 5 years, excluding certain early-stage skin, breast, cervical, or prostate cancers that were fully treated.
  • You have a history of chronic pancreatitis (long-term inflammation of the pancreas) or acute pancreatitis (sudden, severe inflammation of the pancreas) within the last 180 days.
  • You have significant craniofacial abnormalities (differences in the shape of the skull or face) that could make it difficult to breathe.
  • You have been diagnosed with Central Apnea (when the brain fails to signal the muscles to breathe) where it makes up 50% or more of your breathing issues, or Cheyne-Stokes Respiration (a specific pattern of abnormal breathing).
  • You are currently using medical devices for sleep apnea, such as oral appliances (mouthpieces), other than PAP therapy (pressure machines that keep airways open), unless you agree to stop them.
  • You have respiratory diseases (lung or breathing issues) like obesity hypoventilation syndrome (slow breathing due to weight) or daytime hypercapnia (too much carbon dioxide in the blood), or neuromuscular diseases (conditions affecting nerves and muscles) like myasthenia gravis.
  • Your personal life or job prevents you from stopping your PAP therapy (breathing machine) for 7 days before a PSG (a sleep study that monitors your body during sleep).
  • You are unable or unwilling to safely stop using your breathing machine for 7 days before your sleep study.
  • Your obesity is caused by endocrine disorders (hormone imbalances) or specific genetic conditions.
  • You have lost or gained more than 5 kilograms (about 11 pounds) within the 90 days before starting the study.
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Investigated drugs

AMG 133 is an experimental medication given as an injection under the skin. It is being studied to see if it can help improve breathing patterns in adults who have obstructive sleep apnea while also living with being overweight or having obesity.

What is already known about the treatment

Maridebart cafraglutide - This medication is an injectable solution administered through a small needle just under the skin. Currently being studied in advanced clinical trials, it is intended to help adults who have both obstructive sleep apnea and weight concerns. It works by targeting and helping the body break down excess fat cells at a molecular level to reduce weight and improve breathing. This drug belongs to a class of treatments known as fibroblast growth factor receptor agonists.

Investigated diseases

Obstructive sleep apnea - This condition occurs when the muscles in the throat relax too much during sleep, causing the airway to narrow or close completely. This blockage prevents normal breathing and leads to repeated pauses in respiration. As the disease progresses, these interruptions happen more frequently throughout the night. The person may experience periods of low oxygen levels during these episodes. These breathing disturbances can interrupt the natural sleep cycle.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-522703-14-00Protocol code20230225Estimated enrolment250 patientsSponsorAmgen Inc.

sourced from the EU Clinical Trials Register and site verification

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