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A Phase 3 Randomized, Double-blind,Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Maridebart Cafraglutide in Adult Participants with Obstructive Sleep Apnea not on Positive Airway Pressure Therapy and Living with Overweight or Obesity (MARITIME-OSA-2)

Verified siteInvestigationalNo placebo
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What is this trial about?

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

This study is researching moderate to severe obstructive sleep apnea in adults who are living with overweight or obesity. Obstructive sleep apnea is a condition where breathing repeatedly stops and starts during sleep due to blocked airways. The treatment being tested is AMG 133, also known as maridebart cafraglutide, which is given as an injection under the skin. Some participants will receive AMG 133 while others will receive placebo. This medication works by targeting specific receptors in the body that help regulate appetite and metabolism.

The purpose of this study is to demonstrate that maridebart cafraglutide is superior to placebo for improvement in a measure called the Apnea-Hypopnea Index, which counts how many times breathing pauses or becomes shallow during sleep. The study will also look at whether the medication helps with weight loss, reduces inflammation markers in the blood, and improves blood pressure and sleep quality. Participants in this study are adults who have not used positive airway pressure therapy for at least four weeks before joining the study and do not plan to use it during the study.

During the study, participants will receive their assigned treatment for up to 52 weeks. The study involves completing sleep studies to measure breathing patterns during sleep, regular measurements of body weight, blood tests, and questionnaires about sleep quality and daytime sleepiness. Participants will have regular visits with the study team throughout the treatment period to monitor their condition and any effects of the medication.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Randomization and first injection

    After you join the study, you will be randomly assigned to receive either maridebart cafraglutide or a placebo. the assignment is done by the study system and you will not know which you receive.

    The assigned product is given as a subcutaneous injection (an injection under the skin) using a solution for injection. the exact dose in milligrams is defined by the study protocol.

  2. Step 2

    Regular treatment injections

    You will continue to receive injections of the assigned product for the duration of the treatment period, which lasts up to 52 weeks.

    Injections are administered according to the schedule set by the study team, and each injection is given subcutaneously in the same manner as the first dose.

  3. Step 3

    Scheduled clinic visits and assessments

    Throughout the 52‑week period you will attend clinic visits at predetermined times (for example, every 12 weeks). during each visit you will undergo several assessments:

    sleep study to measure the apnea‑hypopnea index (ahi), which counts breathing interruptions during sleep.

    Measurement of body weight and blood pressure (systolic blood pressure).

    Blood draw to evaluate high sensitivity c‑reactive protein (hs‑crp), a marker of inflammation.

    Questionnaires including the epworth sleepiness scale (ess) to assess daytime sleepiness and the promiss short form sleep‑related impairment questionnaire to evaluate sleep quality.

  4. Step 4

    Final evaluation at week 52

    At the end of week 52 you will have a final clinic visit that repeats all the assessments performed during earlier visits.

    The primary focus is the change in the apnea‑hypopnea index from the start of the study to week 52.

    Secondary measurements include the percent change in ahi, achievement of at least a 50% reduction in ahi, achieving an ahi below 5 or between 5 and 14 with an ess score of 10 or less, changes in body weight, hs‑crp, blood pressure, and sleep‑related impairment scores.

  5. Step 5

    Ongoing safety monitoring

    Throughout the study you will be asked to report any side effects or health changes you experience.

    The study team will review safety data regularly to ensure the treatment is tolerated.

Who can join the trial?

7 criteria

  • You have given written permission to join the study (informed consent).
  • You are at least 18 years old (or the legal adult age in your country if it is higher).
  • You have been diagnosed with moderate to severe obstructive sleep apnea and a sleep test showed an Apnea‑Hypopnea Index (AHI) of 15 or higher, using methods such as polysomnography (PSG) or a home sleep apnea test (HSAT).
  • The sleep test done on the first day of the study also shows an AHI of 15 or higher.
  • Your body‑mass index (BMI) is 27 kg/m² or higher at the screening visit.
  • You have tried at least one diet or exercise plan to lose weight that was not successful.
  • You have not used positive airway pressure (PAP) therapy for at least four weeks before screening, are unable or unwilling to use it, and do not plan to use it during the study.

Who cannot join the trial?

13 criteria

  • Had any previous or planned upper airway surgery for sleep apnea or major ear, nose, or throat surgery – surgery that opens or changes the airway in the throat, nose, or ears.
  • History of chronic pancreatitis – long‑term inflammation of the pancreas, the organ that helps digest food.
  • History of acute pancreatitis within 180 days before screening – a sudden, severe inflammation of the pancreas occurring within the past six months.
  • Self‑reported weight change of more than 5 kg (about 11 lb) within 90 days before screening.
  • Previous or planned (during the study) surgical, endoscopic, or device‑based treatment for obesity – any operation, scope‑guided procedure, or device used to lose weight.
  • Significant craniofacial abnormalities that may affect breathing – major differences in the shape of the skull or face that could change how you breathe.
  • Diagnosis of central apnea with 50 % or more of breaths being central, or diagnosis of Cheyne‑Stokes respiration – types of breathing problems where the brain does not send the right signals to breathe.
  • Active device treatment of sleep apnea (e.g., PAP therapy or oral appliances) or other treatments that could interfere, unless you are willing to stop the treatment at screening and throughout the study – PAP means a machine that pushes air into the airway to keep it open.
  • Respiratory diseases such as obesity hypoventilation syndrome or daytime hypercapnia, or neuromuscular diseases such as myasthenia gravis, or other conditions that could interfere – these are breathing problems or muscle disorders that affect breathing.
  • Obesity caused by other endocrine disorders or monogenetic (single‑gene) or syndromic forms of obesity – weight gain due to hormone problems or genetic conditions.
  • Having type 1 diabetes, type 2 diabetes, any other type of diabetes, a history of ketoacidosis, or a hyperosmolar state/coma – conditions where blood sugar regulation is severely impaired.
  • History of a significant medical, behavioral, or psychiatric disorder (other than sleep apnea) that is associated with insomnia (trouble sleeping) or excessive sleepiness.
  • History of malignancy (cancer) within the last 5 years before screening, except for non‑melanoma skin cancers, breast ductal carcinoma in situ, cervical carcinoma in situ, or prostate cancer in situ that have been treated with curative intent.
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Investigated drugs

Maridebart Cafraglutide is an investigational medication being tested to see if it can help adults with obstructive sleep apnea who are overweight or obese and are not using a breathing machine at night. In the study, participants receive the drug as a liquid that is injected just under the skin (subcutaneous injection). Researchers are looking at whether this treatment can lower the number of breathing interruptions during sleep, measured by the Apnea‑Hypopnea Index, and whether it is safe and well tolerated. The medication is given in a solution form designed for injection, and its purpose in the trial is to evaluate its effectiveness compared to a placebo.

What is already known about the treatment

Maridebart Cafraglutide - It is supplied as a clear solution for injection that is given under the skin (subcutaneous injection). The drug is still investigational and has not received regulatory approval, appearing only in early clinical‑trial reports and medical literature. It is being studied to treat moderate to severe obstructive sleep apnea in adults who are overweight or obese and are not using a breathing‑machine therapy. Maridebart cafraglutide works by activating a body protein that reduces appetite and may improve airway muscle tone, and it is classified as a GLP‑1 receptor agonist peptide medication.

Investigated diseases

Obstructive sleep apnea - Obstructive sleep apnea is a sleep‑related breathing disorder in which the upper airway collapses repeatedly during sleep, causing pauses in breathing. These pauses are measured as apnea events and are often accompanied by reduced airflow (hypopnea). In adults who are overweight or obese, the frequency and severity of events are usually moderate to severe. The condition leads to fragmented sleep and increasing daytime sleepiness as the night progresses. Over time, untreated disease can result in a gradual increase in the number of breathing interruptions each night. Weight gain can further worsen the airway obstruction.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-522699-94-00Protocol code20250002Estimated enrolment255 patientsSponsorAmgen Inc.

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