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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)

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-522699-94-00
Enrollment
97
Registered
2026-01-27
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Moderate to severe obstructive sleep apnea (OSA) in adults living with overweight or obesity

Brief summary

Change in AHI from baseline at week 52

Detailed description

Percent change in AHI from baseline at week 52  Achieving ≥ 50% AHI reduction from baseline at week 52  Achieving AHI < 5 or AHI 5 to 14 with Epworth Sleepiness Scale (ESS) ≤10 at week 52  Change in Sleep Apnea-specific Hypoxic burden (%/min/hour) from baseline at week 52, Percent change in body weight from baseline at week 52  Change in high sensitivity C-reactive protein (hs-CRP) from baseline at week 52  Change in SBP (mmHg) from baseline at  Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 Sleep-Related Impairment 8a score from baseline at week 52"

Interventions

DRUGPlacebo for Maridebart cafraglutide (AMG 133)

Sponsors

Amgen Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Change in AHI from baseline at week 52

Secondary

MeasureTime frame
Percent change in AHI from baseline at week 52  Achieving ≥ 50% AHI reduction from baseline at week 52  Achieving AHI < 5 or AHI 5 to 14 with Epworth Sleepiness Scale (ESS) ≤10 at week 52  Change in Sleep Apnea-specific Hypoxic burden (%/min/hour) from baseline at week 52, Percent change in body weight from baseline at week 52  Change in high sensitivity C-reactive protein (hs-CRP) from baseline at week 52  Change in SBP (mmHg) from baseline at  Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 Sleep-Related Impairment 8a score from baseline at week 52"

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026