Maridebart Cafraglutide for Obstructive Sleep Apnea

(MARITIME-OSA-1 Trial)

Not yet recruiting at 5 trial locations

Overseen By Amgen Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Amgen

Disqualifiers: Upper airway surgery, Central apnea, Respiratory diseases, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 52 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called maridebart cafraglutide for individuals with obstructive sleep apnea (OSA) who already use positive airway pressure (PAP) therapy. The researchers aim to determine if this treatment improves OSA symptoms and is safe. The trial compares maridebart cafraglutide to a placebo over a year. Suitable candidates have a history of sleep apnea with frequent breathing pauses during sleep and have struggled to lose weight through diet and exercise. Participants must have used PAP therapy for at least three months before joining the trial. As a Phase 3 trial, this is the final step before FDA approval, offering a chance to contribute to a potentially groundbreaking treatment.

Do I need to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are using any active device treatment for sleep apnea other than PAP therapy, you may need to stop it during the trial.

Is there any evidence suggesting that maridebart cafraglutide is likely to be safe for humans?

Research has shown that maridebart cafraglutide is generally safe for people. In earlier studies, patients experienced significant weight loss with this treatment, and no major safety issues were reported. Some participants had mild side effects, but these were usually manageable and did not lead to discontinuation of the treatment. The treatment's progression to a Phase 3 trial indicates that earlier studies deemed it safe enough for broader testing. This provides some confidence in its safety. However, individual experiences may vary with any treatment. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for sleep apnea?

Unlike the standard treatments for obstructive sleep apnea, which often include CPAP machines or oral appliances, Maridebart Cafraglutide offers a novel approach through its unique active ingredient administered via subcutaneous injection. This new treatment targets underlying metabolic pathways, which could lead to improved airway function and overall sleep quality. Researchers are excited because it represents a potential breakthrough for patients who struggle with traditional therapies, offering a less cumbersome and possibly more effective solution.

What evidence suggests that maridebart cafraglutide might be an effective treatment for obstructive sleep apnea?

Research shows that maridebart cafraglutide, which participants in this trial may receive, can aid in weight loss, crucial for individuals with obstructive sleep apnea (OSA). One study found that this medication led to significant and lasting weight loss over a year. Losing weight may reduce the severity of OSA in those who are overweight or obese. Specifically, previous patients experienced meaningful improvements without hitting a weight loss plateau. This suggests that maridebart cafraglutide could effectively manage OSA by addressing one of its root causes. ^{1 3 4 6 7}

Who Is on the Research Team?

MD

Principal Investigator

Amgen

Are You a Good Fit for This Trial?

This trial is for adults with obstructive sleep apnea who are overweight or obese, have an AHI (Apnea-Hypopnea Index) of 15 or more, a BMI of 27 kg/m2 or higher, and have tried to lose weight unsuccessfully. They must be on PAP therapy for at least three months before the trial and plan to continue it throughout.

Inclusion Criteria

I have tried and failed to lose weight through diet and exercise.

My sleep study shows I have moderate to severe sleep apnea.

My BMI is 27 or higher.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive maridebart cafraglutide or placebo subcutaneously over a 52-week period

52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Maridebart Cafraglutide

Trial Overview The study tests maridebart cafraglutide against a placebo over one year in participants with OSA on PAP therapy. It aims to assess if this drug can improve their condition better than a non-active treatment.

How Is the Trial Designed?

Group I: Maridebart Cafraglutide Experimental Treatment 1 Intervention

Participants will receive maridebart cafraglutide subcutaneously (SC).

Group II: Placebo Placebo Group 1 Intervention

Participants will receive placebo SC.

Who Is Running the Clinical Trial?

Amgen

Lead Sponsor

Trials

1,508

Recruited

1,433,000+

Founded

1980

Headquarters

Thousand Oaks, USA

Known For

Human Therapeutics

Top Products

Enbrel, Prolia, Neulasta, Otezla

Robert A. Bradway

Amgen

Chief Executive Officer since 2012

MBA from Harvard Business School

Paul Burton

Amgen

Chief Medical Officer since 2023

MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07226765

NCT07226765 | Maridebart Cafraglutide Versus Placebo in ... This Phase 3 clinical trial is designed to evaluate the efficacy and safety of maridebart cafraglutide compared to placebo over a 52-week period in adults with ...

2. withpower.com withpower.com/trial/phase-3-obesity-11-2025-acff4

Maridebart Cafraglutide for Obstructive Sleep Apnea Research shows that maridebart cafraglutide has promising results for weight loss, which is crucial for individuals with obstructive sleep apnea ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07225686

NCT07225686 | Maridebart Cafraglutide Versus Placebo in ... This Phase 3 clinical trial is designed to evaluate the efficacy and safety of maridebart cafraglutide compared to placebo over a 52-week period ...

4. investors.amgen.com investors.amgen.com/node/36511/pdf

RESULTS FROM AMGEN'S PHASE 2 OBESITY STUDY ... "MariTide delivered strong efficacy, including sustained weight loss without a plateau in the 52-week Phase 2 study and meaningful improvements ...

5. nejm.org nejm.org/doi/full/10.1056/NEJMoa2504214

Once-Monthly Maridebart Cafraglutide for the Treatment ... In this phase 2 trial, once-monthly maridebart cafraglutide resulted in substantial weight reduction in participants with obesity with or without type 2 ...

6. amgen.com amgen.com/newsroom/press-releases/2025/06/results-from-amgens-phase-2-obesity-study-of-monthly-maritide-presented-at-the-american-diabetes-association-85th-scientific-sessions

RESULTS FROM AMGEN'S PHASE 2 OBESITY STUDY ... MariTide, the first monthly or less frequently dosed obesity treatment, demonstrated up to ~20% average weight loss without a weight loss plateau.

7. ctv.veeva.com ctv.veeva.com/study/maridebart-cafraglutide-versus-placebo-in-adult-participants-with-obstructive-sleep-apnea-on-positiv

Maridebart Cafraglutide Versus Placebo in Adult Participants ... This Phase 3 clinical trial is designed to evaluate the efficacy and safety of maridebart cafraglutide compared to placebo over a 52-week ...