MARIDEBART CAFRAGLUTIDE for Obstructive sleep apnea

Inclusion criteria

• {"criterion_text":"- Participant has provided informed consent before initiation of any study-specific activities/procedures."}
• {"criterion_text":"- Age ≥ 18 years (or ≥ legal age within the country if it is older than 18 years)."}
• {"criterion_text":"- Documented history of previously diagnosed moderate-to-severe OSA with an AHI ≥ 15, as diagnosed with PSG, HSAT (REI ≥ 15 by HSAT), or other method that meets local guidelines before screening."}
• {"criterion_text":"- AHI ≥ 15 on PSG at day 1 before randomization."}
• {"criterion_text":"- BMI ≥ 27 kg/m2 at screening."}
• {"criterion_text":"- History of at least 1 unsuccessful attempt at weight loss by diet and exercise."}
• {"criterion_text":"- On PAP therapy for at least 3 consecutive months before screening and plan to continue PAP therapy during the study"}

Exclusion criteria

• {"criterion_text":"- Had any previous or planned upper airway surgery for sleep apnea or major ear, nose, or throat surgery"}
• {"criterion_text":"- Previous or planned (during the study) surgical, endoscopic, or device-based treatment for obesity."}
• {"criterion_text":"- Have Type 1 or Type 2 Diabetes Mellitus, or any other type of diabetes, history of ketoacidosis, or hyperosmolar state/coma"}
• {"criterion_text":"- History of clinically relevant medical, behavioral, or psychiatric disorder, other than OSA, that is associated with insomnia or excessive sleepiness."}
• {"criterion_text":"- History of malignancy within the last 5 years before screening (except nonmelanoma skin cancers, breast ductal carcinoma in situ, cervical carcinoma in situ, or prostate cancer in situ that have been treated with curative intent)."}
• {"criterion_text":"- History of chronic pancreatitis."}
• {"criterion_text":"- History of acute pancreatitis within 180 days before screening."}
• {"criterion_text":"- Significant craniofacial abnormalities that may affect breathing at screening."}
• {"criterion_text":"- Diagnosis of Central Apnea with % of central apneas/hypopneas ≥ 50%, and/or diagnosis of Cheyne Stokes Respiration."}
• {"criterion_text":"- Active device treatment of OSA other than PAP therapy (eg, oral appliances), or other treatments, that in the opinion of the investigator, may interfere with study outcomes, unless willing to stop treatment at screening and throughout the study"}
• {"criterion_text":"- Respiratory diseases such as obesity hypoventilation syndrome or daytime hypercapnia, or neuromuscular diseases such as myasthenia gravis or other conditions that could interfere with the results of the trial in the opinion of the investigator"}
• {"criterion_text":"- Have personal circumstances or job-related responsibilities that prevent a 7-day PAP withdrawal before PSG testing during the course of the study"}
• {"criterion_text":"- Are unwilling or unsafe in the opinion of investigator to stop PAP therapy for 7 days before PSG testing during the course of the study"}
• {"criterion_text":"- Obesity induced by other endocrine disorders or monogenetic or syndromic forms of obesity."}
• {"criterion_text":"- Self-reported change in body weight > 5 kg within 90 days before screening."}

Primary endpoints

• {"endpoint_text":"- Change in AHI from baseline at week 52","definition_or_measurement_approach":"Change in Apnea-Hypopnea Index (AHI) from baseline to week 52 (AHI as defined in protocol; measured per protocol timepoints)."}

Secondary endpoints

• {"endpoint_text":"- Percent change in AHI from baseline at week 52\n- Achieving ≥ 50% AHI reduction from baseline at week 52\n- Achieving AHI < 5 or AHI 5 to 14 with Epworth Sleepiness Scale (ESS) ≤10 at week 52\n- Change in Sleep Apnea-specific Hypoxic burden (%/min/hour) from baseline at week 52","definition_or_measurement_approach":"Secondary AHI-related endpoints measured as percent change or categorical reductions from baseline to week 52; hypoxic burden change from baseline to week 52."}
• {"endpoint_text":"- Percent change in body weight from baseline at week 52\n- Change in high sensitivity C-reactive protein (hs-CRP) from baseline at week 52\n- Change in SBP (mmHg) from baseline at\n- Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 Sleep-Related Impairment 8a score from baseline at week 52","definition_or_measurement_approach":"Body weight percent change, hs-CRP change, SBP change, and PROMIS SRI 8a score change assessed from baseline to week 52 as specified in protocol."}

Methods

• Physician referral letters (physician-facing referral letters) — channel: physician-to-site referrals; country-specific referral materials present (e.g., Germany, Spain, Poland, France, Hungary, Czechia).
• GP letters — channel: general practitioner letters to identify/refer eligible patients (GP letter documents present in recruitment materials).
• Site-based recruitment arrangements and site-specific materials (K1 recruitment arrangements) — channel: hospital/clinic sites and specialist centres across participating countries.
• Recruitment and retention materials provided by CRO/vendor (IQVIA) including sleep apnea clinical assessment materials.
• Patient-facing materials and questionnaires (PROMIS, ESS, FOSQ, PHQ-9, PGI scales) distributed via sites in multiple languages to support screening and enrolment.

Czechia

Earliest CTIS Part Ii Submission Date

03-02-2026

Latest Decision Or Authorization Date

10-02-2026

Processing Time Days

7

Number Of Sites

3

Number Of Participants

20

Germany

Earliest CTIS Part Ii Submission Date

03-02-2026

Latest Decision Or Authorization Date

10-02-2026

Processing Time Days

7

Number Of Sites

6

Number Of Participants

25

Hungary

Earliest CTIS Part Ii Submission Date

05-02-2026

Latest Decision Or Authorization Date

13-02-2026

Processing Time Days

8

Number Of Sites

5

Number Of Participants

20

Spain

Earliest CTIS Part Ii Submission Date

02-02-2026

Latest Decision Or Authorization Date

12-02-2026

Processing Time Days

10

Number Of Sites

6

Number Of Participants

20

Poland

Earliest CTIS Part Ii Submission Date

05-02-2026

Latest Decision Or Authorization Date

16-02-2026

Processing Time Days

11

Number Of Sites

3

Number Of Participants

12

Primary sponsor

Full Name

Amgen Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

IQVIA Limited

Responsibilities

Recruitment and Retention Material, Sleep Apnea Clinical Assessment

Name

Icon Clinical Research Limited

Responsibilities

MRI

Name

Labcorp Central Laboratory Services SARL

Responsibilities

4

Name

Altasciences Compagnie Inc.

Responsibilities

4

Name

Suvoda LLC

Responsibilities

3

Name

Bioagilytix Labs LLC

Responsibilities

4

Name

Eresearchtechnology Inc.

Responsibilities

7

Name

The Brigham And Women’s Hospital Inc.

Responsibilities

8

Third parties

• {"country":"United Kingdom","full_name":"Medical Equipment Supplies And Management Limited","duties_or_roles":"Equipment","organisation_type":"Pharmaceutical company"}
• {"country":"Canada","full_name":"Altasciences Compagnie Inc.","duties_or_roles":"4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"3","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"Recruitment and Retention Material, Sleep Apnea Clinical Assessment","organisation_type":"Pharmaceutical company"}
• {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"4","organisation_type":"Pharmaceutical company"}
• {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"MRI","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Bioagilytix Labs LLC","duties_or_roles":"4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"7","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"The Brigham And Women’s Hospital Inc.","duties_or_roles":"8","organisation_type":"Hospital/Clinic/Other health care facility"}