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Maridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea on Positive Airway Pressure Therapy

ConditionsObesityObstructive Sleep Apnea
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-99
SponsorAmgen

About this trial

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 obstructive sleep apnea (OSA) who are receiving positive airway pressure (PAP) therapy and are living with overweight or obesity.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

AHI ≥ 15 on polysomnography at day 1 before randomization.

BMI ≥ 27 kg/m² at screening.

History of at least 1 unsuccessful attempt at weight loss by diet and exercise.

On positive airway pressure (PAP) therapy for at least 3 consecutive months before screening and plan to continue PAP therapy during the trial.

Disqualifiers

Had any previous or planned upper airway surgery for sleep apnea or major ear, nose, or throat surgery.

Significant craniofacial abnormalities that may affect breathing at screening.

Diagnosis of Central Apnea with % of central apneas/hypopneas ≥ 50%, and/or diagnosis of Cheyne Stokes Respiration.

Active device treatment of obstructive sleep apnea other than PAP therapy (eg, oral appliances), or other treatments, that in the opinion of the investigator, may interfere with trial outcomes, unless willing to stop treatment at screening and throughout the trial.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Maridebart cafraglutide

    Drug

    Participants will receive maridebart cafraglutide as SC injections.

  • Placebo

    Drug

    Participants will receive placebo SC.

Treatment groups

250 Participants
are divided into 2 treatment groups
Group A: Maridebart CafraglutideExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in AHI from baseline at week 52

Time frame
At Week 52

Secondary outcomes

1

Percentage Change in AHI from baseline at week 52

Time frame
At Week 52
2

Participants Achieving ≥ 50% AHI Reduction from baseline at week 52

Time frame
At Week 52
3

Participants Achieving AHI < 5 or AHI 5 to 14 with Epworth Sleepiness Scale (ESS) ≤ 10 from baseline at week 52

Time frame
At Week 52
4

Percentage Change in Body Weight from baseline at Week 52

Time frame
At Week 52

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Amgen

Lead sponsor

Source ClinicalTrials.gov
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