Maridebart Cafraglutide for Obstructive Sleep Apnea

(MARITIME-OSA-2 Trial)

Recruiting at 4 trial locations

Overseen By Amgen Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Amgen

Disqualifiers: Upper airway surgery, Craniofacial abnormalities, Central apnea, Cheyne Stokes, 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

250 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the effectiveness and safety of maridebart cafraglutide, a new potential drug, for treating obstructive sleep apnea (OSA) in overweight or obese adults. The trial includes two groups: one will receive the actual treatment, while the other will receive a placebo, a harmless pill or shot with no effect. It suits individuals who have unsuccessfully tried to lose weight through diet and exercise, have moderate to severe sleep apnea, do not use CPAP machines, and do not plan to start during the trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

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

The trial information does not specify if you need to stop taking your current medications. However, if you are using any active device treatment for sleep apnea, you must stop it before and during the study.

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

Research has shown that maridebart cafraglutide has been tested in other trials focused on weight loss. In one study, participants steadily lost weight over a year, suggesting the treatment works well and is generally safe.

Regarding safety, earlier studies found that most people tolerated the treatment well, experiencing no serious side effects. However, some experienced mild to moderate side effects, such as nausea and diarrhea, which are common with many medications.

Since this study is in a later stage, maridebart cafraglutide has already demonstrated reasonable safety in earlier research. This increases confidence in the treatment's safety for most people. Still, discussing any potential risks with a doctor before deciding is important. ^{1 2 3 4 5}

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

Most treatments for obstructive sleep apnea involve lifestyle changes, continuous positive airway pressure (CPAP) machines, or oral appliances that help keep the airway open during sleep. But maridebart cafraglutide works differently, targeting the condition at a biological level. It's an experimental drug administered subcutaneously and is believed to affect pathways that regulate breathing during sleep. Researchers are excited about its potential to offer a new therapeutic option for those who struggle with traditional mechanical treatments, potentially improving patient compliance and quality of life.

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

Research shows that maridebart cafraglutide has promising results for weight loss, which is crucial for individuals with obstructive sleep apnea (OSA) who are overweight or obese. Previous studies found that participants lost a significant amount of weight and maintained it over a year. This weight loss is important because it can help reduce OSA symptoms. Maridebart cafraglutide affects how the body controls hunger and stores fat, potentially leading to better sleep. This trial will evaluate maridebart cafraglutide's potential to improve OSA in individuals with obesity, compared to a placebo. ^{1 2 5 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 a BMI of 27 kg/m^2 or higher, and have tried to lose weight unsuccessfully. They must not be on PAP therapy and should have an AHI of 15+ as confirmed by a sleep study.

Inclusion Criteria

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

My BMI is 27 or higher.

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

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

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Maridebart Cafraglutide

Trial Overview The trial is testing the effectiveness and safety of maridebart cafraglutide versus placebo over one year in managing obstructive sleep apnea in patients not using PAP therapy but struggling with excess weight.

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/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 ...

2. 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 ...

3. 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 ...

4. 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 ...

5. trialstoday.org trialstoday.org/trial/NCT07226765

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

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 delivered strong efficacy, including sustained weight loss without a plateau in the 52-week Phase 2 study and meaningful improvements ...

7. amgentrials.com amgentrials.com/study/?id=20190218

AMGEN - Dose-ranging Study to Evaluate the Efficacy, ... The study aims to compare and assess the dose response of 3 selected doses of maridebart cafraglutide compared with placebo, on inducing and maintaining ...