Maridebart Cafraglutide versus Placebo in Adult Participants with Obstructive Sleep Apnea on Positive Airway Pressure Therapy (MARITIME-OSA-1)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Amgen Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

Trial duration

17 Feb 2026 → ongoing

Decision date (initial)

2026-02-10

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Amgen Inc.

External identifiers

EU CT number

2025-522703-14-00

WHO UTN

U1111-1326-6377

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

To demonstrate that maridebart cafraglutide is superior to placebo for improvement in Apnea-Hypopnea Index (AHI)

Secondary objectives 9

1. "To demonstrate that Maridebart cafraglutide is superior to placebo for: - Percent change in AHI - Clinically meaningful reduction in AHI - Obstructive sleep apnea (OSA) remission or mild asymptomatic OSA"
2. To demonstrate that Maridebart cafraglutide is superior to placebo for reduction in body weight
3. To demonstrate that Maridebart cafraglutide is superior to placebo for reduction in hypoxic burden
4. To demonstrate that maridebart cafraglutide is superior to placebo for reduction in inflammation
5. To demonstrate that maridebart cafraglutide is superior to placebo for improvement in systolic blood pressure (SBP)
6. To demonstrate that maridebart cafraglutide is superior to placebo for improvement in patient-reported sleep-related impairment
7. "To demonstrate that maridebart cafraglutide is superior to placebo for: Reduction in body weight, Reduction in central adiposity, Reduction in neck circumference, Improvement in lipid parameters, Improvement in metabolic parameters, Improvement in diastolic blood pressure (DBP)"
8. "To characterize the safety and tolerability of maridebart cafraglutide"
9. "To characterize the pharmacokinetics (PK) of maridebart cafraglutide"

Conditions and MedDRA coding

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

Study design 2 periods

Regulatory references

EMA paediatric investigation plan (PIP)

EMEA-003439-PIP02-23

Plan to share IPD

Yes

IPD plan description

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request. Information on IPD sharing Access Criteria, Time Frame and Supporting Information Type is available on ClinicalTrials.gov and on the Amgen Clinical Trials portal (http://www.amgen.com/datasharing).

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Participant has provided informed consent before initiation of any study-specific activities/procedures.
2. Age ≥ 18 years (or ≥ legal age within the country if it is older than 18 years).
3. 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.
4. AHI ≥ 15 on PSG at day 1 before randomization.
5. BMI ≥ 27 kg/m2 at screening.
6. History of at least 1 unsuccessful attempt at weight loss by diet and exercise.
7. On PAP therapy for at least 3 consecutive months before screening and plan to continue PAP therapy during the study

Exclusion criteria 15

1. Had any previous or planned upper airway surgery for sleep apnea or major ear, nose, or throat surgery
2. Significant craniofacial abnormalities that may affect breathing at screening.
3. Diagnosis of Central Apnea with % of central apneas/hypopneas ≥ 50%, and/or diagnosis of Cheyne Stokes Respiration.
4. 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
5. 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
6. Have personal circumstances or job-related responsibilities that prevent a 7-day PAP withdrawal before PSG testing during the course of the study
7. 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
8. Obesity induced by other endocrine disorders or monogenetic or syndromic forms of obesity.
9. Self-reported change in body weight > 5 kg within 90 days before screening.
10. Previous or planned (during the study) surgical, endoscopic, or device-based treatment for obesity.
11. Have Type 1 or Type 2 Diabetes Mellitus, or any other type of diabetes, history of ketoacidosis, or hyperosmolar state/coma
12. History of clinically relevant medical, behavioral, or psychiatric disorder, other than OSA, that is associated with insomnia or excessive sleepiness.
13. 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).
14. History of chronic pancreatitis.
15. History of acute pancreatitis within 180 days before screening.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change in AHI from baseline at week 52

Secondary endpoints 2

1. " 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"
2. " 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"

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Amgen Inc.

Sponsor organisation

Amgen Inc.

Address

1 Amgen Center Drive

City

Thousand Oaks

Postcode

91320-1730

Country

United States

Scientific contact point

Organisation

Amgen Inc.

Contact name

Medical Information

Public contact point

Organisation

Amgen Inc.

Contact name

Medical Information

Third parties 9

Locations

6 EU/EEA countries · 28 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 133 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications