It is essential for clinicians to remain informed about emerging clinical trial opportunities and resulting data that may inform therapeutic strategies, affect clinical guidelines, expand treatment options, and ultimately improve patient quality of life.
Today, we are previewing five Phase 3 clinical trials on obstructive sleep apnea that have estimated primary completion dates by the end of next year. Some of the featured trials are on patients with sleep apnea in combination with obesity or overweight. The following trials are arranged by start date.
Quick View Table of Obstructive Sleep Apnea Clinical Trials
| Study Title | Recruiting? | Phase | Estimated Enrollment | Start Date | Estimated Primary Completion |
|---|---|---|---|---|---|
| Maridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea on Positive Airway Pressure Therapy (MARITIME-OSA-1) | Yes | 3 | 250 | December 2025 | September 2027 |
| Maridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea Not on Positive Airway Pressure (PAP) Therapy (MARITIME-OSA-2) | Yes | 3 | 250 | November 2025 | September 2027 |
| A Master Protocol for Orforglipron in Participants With Obstructive Sleep Apnea and Obesity or Overweight | No | 3 | 600 | October 2024 | November 2026 |
| Continuation Protocol for Obstructive Sleep Apnea (OSA) | By invitation | 3 | 1280 | July 2024 | June 2026 |
| RePOSA-Revealing the Efficacy of IHL-42X Use in Patients With OSA (REPOSA) | No | 2,3 | 560 | May 2024 | December 2026 |
Featured Obstructive Sleep Apnea Phase 3 Clinical Trials
Maridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea on Positive Airway Pressure Therapy (MARITIME-OSA-1)
- Sponsor: Amgen
- Goal: 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.
- Interventions: Maridebart cafraglutide, placebo
- Primary Outcome Measure: Change in AHI from baseline at week 52.
- Time Frame: At week 52.
- Study Details
- Source
Maridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea Not on Positive Airway Pressure (PAP) Therapy (MARITIME-OSA-2)
- Sponsor: Amgen
- Goal: 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 not on PAP therapy and are living with overweight or obesity.
- Interventions: Maridebart cafraglutide, placebo
- Primary Outcome Measure: Change in Apnea-hypopnea Index (AHI) from baseline at Week 52
- Time Frame: At week 52.
- Study Details
- Source
A Master Protocol for Orforglipron in Participants With Obstructive Sleep Apnea and Obesity or Overweight (ATTAIN-OSA)
- Sponsor: Eli Lily and Company
- Goal: The purpose of the studies is to evaluate the efficacy and safety of orforglipron in participants who have moderate-to-severe OSA and obesity or overweight.
- Interventions: Orforglipron, placebo
- Primary Outcome Measure: Change from Baseline in Apnea-Hypopnea Index (AHI)
- Time Frame: Baseline to week 52.
- Study Details
- Source
Continuation Protocol for Obstructive Sleep Apnea (OSA)
- Sponsor: Apnimed
- Goal: The present study is a Phase 3 open label continuation protocol enrolling qualifying participants who completed one of the parent Phase 3 double-blind placebo-controlled studies, APC-APN-304 or APC-APN-305.
- Interventions: Aroxybutynin, Atomoxetine
- Primary Outcome Measures: Number of Participants With Adverse Events (AES) and Serious Adverse Events (SAEs); Number of Participants With Vital Signs Abnormalities; Number of Participants With Concomitant Therapy (Medication or Devices).
- Time Frames: Through study completion, an average of 1 year; Through study completion, an average of 1 year; Through study completion, an average of 1 year.
- Study Details
- Source
RePOSA-Revealing the Efficacy of IHL-42X Use in Patients With OSA (REPOSA)
- Sponsor: Icannex Healthcare
- Goal: The goal of this randomised, double-blind phase II/III clinical trial is to determine the safety and efficacy of IHL-42X in subjects with obstructive sleep apnoea who are intolerant, non-compliant, or naïve to positive airway pressure.
- Interventions: IHL-42X low dose/high dose/optimale dose, dronabinol, axetazolamides, placebos
- Primary Outcome Measures: Change in apnea-hypopnea index (AHI); Change in apnea-hypopnea index (AHI).
- Time Frames: 4 weeks; 52 weeks.
- Study Details
- Source
Related Clinical Guidelines:
- Evaluation and Management of Obstructive Sleep Apnea in Adults Hospitalized for Medical Care
- American Academy of Sleep Medicine
- December 2025
- Treatment of Adult Obstructive Sleep Apnea with Positive Airway Pressure
- American Academy of Sleep Medicine
- February 2019
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