Obstructive Sleep ApneaPhase 3MARITIME-OSA-2NCT07226765
Maridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea Not on Positive Airway Pressure (PAP) Therapy
A Phase 3 study testing Maridebart cafraglutide in people with Obstructive Sleep Apnea, run by Amgen at 57 sites in 11 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Maridebart cafraglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 57 sitesin 11 countries
- Study dates
- 25 Nov 2025to 13 Sep 2028
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must have an AHI of 15 or higher on polysomnography (PSG) at Day 1 before randomization.
- Body Mass Index (BMI) of 27 kg/m^2 or more at the time of screening.
- History of at least one unsuccessful attempt at weight loss through diet and exercise.
- Participants must not have used PAP therapy for at least 4 weeks before screening, are unwilling/unable to use PAP, and do not plan to use PAP therapy during the study.
Who cannot join
- Individuals who have had any previous or planned upper airway surgery or major ear, nose or throat surgery for OSA.
- Those with significant craniofacial abnormalities that may affect breathing at screening.
- Participants diagnosed with Central or Mixed Sleep Apnea with proportion of mixed or central apneas/hypopneas ≥ 50%, and/or diagnosis of Cheyne Stokes Respiration.
- Active device treatment of OSA or other treatments, that in the opinion of the investigator, may interfere with study outcomes.
- Individuals with respiratory diseases like obesity hypoventilation syndrome or daytime hypercapnia, neuromuscular diseases or other conditions that could interfere with the trial results, according to the investigator's opinion.
Trial locations and contacts
57 sites in 11 countries.
57 sites in 11 countries
United States13 sites
NeuroTrials Research
Atlanta, Georgia, 30328
FutureSearch Trials of Neurology
Austin, Texas, 78731
Northwest Clinical Research Center
Bellevue, Washington, 98007
Teradan Clinical Trials
Brandon, Florida, 33511
CTI Clinical Research Center
Cincinnati, Ohio, 45212
Epic Medical Research - DeSoto
DeSoto, Texas, 75115
Basil Clinical
Laurelton, New York, 11413
Monroe Biomedical Research
Monroe, North Carolina, 28112
Valley Clinical Trials
Northridge, California, 91325
Destiny Research Center
Palmetto Bay, Florida, 33157
Clinical Research Center Of Florida
Pompano Beach, Florida, 33060
Peninsula Research Associates
Rolling Hills Estates, California, 90274
Sleep Therapy & Research Center
San Antonio, Texas, 78229
Japan9 sites
Mazda Hospital of Mazda Motor Corporation
Aki-gun, Hiroshima, 735-8585
Saiseikai Futsukaichi Hospital
Chikushino-shi, Fukuoka, 818-8516
Fukuoka University Hospital
Fukuoka, Fukuoka, 814-0180
Sleep and Mental Clinic-Kitahiroshima
Kitahiroshima-shi, Hokkaido, 061-1121
Kuwamizu Hospital
Kumamoto, Kumamoto, 862-0954
Goodsleep Clinic
Minato-ku, Tokyo, 105-0012
Gokeikai Osaka Kaisei Hospital
Osaka, Osaka, 532-0003
Nakamura Clinic
Urasoe-shi, Okinawa, 901-2132
RESM ShinYokohama Sleep and Respiratory Medical Care Clinic
Yokohama, Kanagawa, 222-0033
Germany6 sites
Advanced Sleep Research
Berlin, 10117
InnoDiab Forschung
Essen, 45136
Diabeteszentrum Hamburg West
Hamburg, 22607
Siteworks - Zentrum fuer klinische Studien Hannover
Hanover, 30449
Siteworks - Zentrum fuer klinische Studien Karlsruhe
Karlsruhe, 76137
Red-Institut GmbH
Oldenburg, 23758
Brazil5 sites
Instituto de Pesquisa Clinica de Campinas - Ipecc
Campinas, São Paulo, 13060-080
Nucleo de Pesquisa do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, 90430-001
CPQuali Pesquisa Clinica Ltda
São Paulo, São Paulo, 01228-000
Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo Hcfmusp
São Paulo, São Paulo, 05403-900
Centro Paulista de Investigacao Clinica Cepic
São Paulo, 04266-010
Spain5 sites
Hospital Medico Quirurgico San Rafael
A Coruña, Galicia, 15006
Centro Medico Teknon
Barcelona, Catalonia, 08022
Hospital Universitari Vall d Hebron
Barcelona, Catalonia, 08035
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Quiron Madrid
Pozuelo de Alarcón, Madrid, 28223
Canada4 sites
Aggarwal and Associates Ltd
Brampton, Ontario, L6T 0G1
CaRe Clinic
Calgary, Alberta, T2N 4L7
Wharton Medical Clinic
Hamilton, Ontario, L8L 5G8
Diex Recherche Trois Rivieres
Trois-Rivières, Quebec, G9A 4P3
Australia3 sites
Monash Medical Centre
Clayton, Victoria, 3168
Royal Brisbane and Womens Hospital
Herston, Queensland, 4006
Woolcock Institute of Medical Research
Macquarie Park, New South Wales, 2113
Czechia3 sites
Nemocnice Rudolfa a Stefanie Benesov as
Benesov U Prahy, 256 01
Fakultni nemocnice Brno
Brno, 625 00
Cerebrovaskularni poradna sro
Ostrava - Poruba, 708 00
France3 sites
Centre Hospitalier Universitaire d'Angers
Angers, 49933
Centre Hospitalier Universitaire de Bordeaux - Hopital Pellegrin
Bordeaux, 33000
Centre Hospitalier Universitaire de Grenoble - Hopital Nord Michallon
Grenoble, 38043
Hungary3 sites
SomnoCenter Budapest Alvaszavar Kozpont
Budapest, 1012
Debreceni Egyetem Klinikai Kozpont
Debrecen, 4032
Reformatus Pulmonologiai Centrum
Törökbálint, 2045
Poland3 sites
Uniwersytecki Szpital Kliniczny w Bialymstoku
Bialystok, 15-276
Uniwersytecki Szpital Kliniczny w Poznaniu
Poznan, 60-569
Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy
Warsaw, 04-635
About this study
Official title: 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)
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.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Maridebart cafraglutide, Placebo
- Keywords
- Obstructive sleep apnea, OSA, Overweight, Obesity, Maridebart Cafraglutide, AMG 133, MariTide
- Medical subject headings
- Sleep Apnea, Obstructive, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maridebart cafraglutideDrug
Also called AMG 133, MariTide
Participants will receive maridebart cafraglutide SC.
PlaceboDrug
Participants will receive placebo SC.
| Study group | Role | What they receive |
|---|---|---|
| Maridebart Cafraglutide | Experimental | Participants will receive maridebart cafraglutide subcutaneously (SC). Receives: Drug: Maridebart cafraglutide |
| Placebo | Placebo comparator | Participants will receive placebo SC. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Apnea-hypopnea Index (AHI) from baseline at Week 52
Measured: At Week 52
Secondary outcomes (28)
Percent Change in AHI from baseline at Week 52
Measured: At Week 52
Participants Achieving ≥ 50% AHI Reduction from baseline at Week 52
Measured: At Week 52
Participants Achieving AHI < 5 or AHI 5 to 14 with Epworth Sleepiness Scale (ESS) ≤ 10 from baseline at Week 52
Measured: At Week 52
Percent Change in Body Weight from baseline at Week 52
Measured: At Week 52
Change in Sleep Apnea-specific Hypoxic Burden (SASHB) from baseline at Week 52
Measured: At Week 52
Percent Change in High Sensitivity C-reactive Protein (hs-CRP) from baseline at Week 52
Measured: At Week 52
Change in Systolic Blood Pressure (SBP) from baseline at Week 48
Measured: At Week 48
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 Sleep-related Impairment 8a Score from baseline at Week 52
Measured: At Week 52
Change in AHI from Baseline at Week 24
Measured: At Week 24
Percent Change in AHI from Baseline at Week 24
Measured: At Week 24
Change in SASHB from Baseline at Week 24
Measured: At Week 24
Change in ESS Score from Baseline at Week 52
Measured: At Week 52
Change in PROMIS Short Form v1.0 Sleep-related Impairment 8b Score from Baseline at Week 52
Measured: At Week 52
Change in Short Form-36 Health Survey Version 2 (SF-36v2) Acute Domain and Summary Scores from Baseline at Week 52
Measured: At Week 52
Change in Patient Global Impression of Severity (PGI-S) Sleep-Related Impairment, Sleep Quality, Sleepiness from Baseline at Week 52
Measured: At Week 52
Percentage of Participants Achieving ≥10% Reduction in Body Weight from Baseline at Week 52
Measured: At Week 52
Percentage of Participants Achieving ≥15% Reduction in Body Weight from Baseline at Week 52
Measured: At Week 52
Percentage of Participants Achieving ≥20% Reduction in Body Weight from Baseline at Week 52
Measured: At Week 52
Change in Waist Circumference From Baseline at Week 52
Measured: At Week 52
Change in Waist-to-Height Ratio From Baseline at Week 52
Measured: At Week 52
Change in Neck Circumference From Baseline at Week 52
Measured: At Week 52
Percentage Change in Total Cholesterol, High-density Lipoprotein Cholesterol (HDL-C), Non-HDL-C, Low-density Lipoprotein Cholesterol (LDL-C), and Triglycerides from Baseline at Week 52 in Fasting Conditions
Measured: At Week 52
Percent Change in Fasting Insulin From Baseline at Week 52
Measured: At Week 52
Change in Fasting Plasma Glucose (FPG) (mg/dL, mmol/L) From Baseline at Week 52
Measured: At Week 52
Change in Hemoglobin A1c From Baseline at Week 52
Measured: At Week 52
Change in Diastolic Blood Pressure (DBP) From Baseline at Week 48
Measured: At Week 48
Number of Participants with Treatment-emergent Adverse Events and Serious Adverse Events
Measured: Up to Week 100
Plasma Concentration of Maridebart Cafraglutide at Week 52
Measured: At Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2025
- Study start25 Nov 2025
- Primary completion30 Aug 2027 (estimated)
- Study completion13 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07226765
- Sponsor's protocol ID
- 20250002
- Acronym
- MARITIME-OSA-2
- Status last verified
- Sep 2026
- First submitted
- 6 Nov 2025
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.