DRUG
Maridebart cafraglutide
Participants will receive maridebart cafraglutide as SC injections.
Maridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea on Positive Airway Pressure Therapy
Status
Recruiting
Phase
Phase 3
Enrollment
250
Locations
60
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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
Treatment arms and agents.
DRUG
Placebo
Participants will receive placebo SC.
Timeline
From registration to results.
First posted
Nov 10, 2025
Study start
Dec 19, 2025
Primary completion
Sep 29, 2027
Study completion
Sep 13, 2028
Results posted
Not reported
Registry updated
Jun 12, 2026
Outcomes
What the study measures.
Primary outcomes
Change in AHI from baseline at week 52
Time frame · At Week 52
Secondary outcomes
Percentage Change in AHI from baseline at week 52
Time frame · At Week 52
Participants Achieving ≥ 50% AHI Reduction from baseline at week 52
Time frame · At Week 52
Participants Achieving AHI < 5 or AHI 5 to 14 with Epworth Sleepiness Scale (ESS) ≤ 10 from baseline at week 52
Time frame · At Week 52
Percentage Change in Body Weight from baseline at Week 52
Time frame · At Week 52
Change in Sleep Apnea-specific Hypoxic Burden (SASHB) from baseline at Week 52
Time frame · At Week 52
Change in High Sensitivity C-reactive Protein (hs-CRP) from baseline at Week 52
Time frame · At Week 52
Change in Systolic Blood Pressure from baseline at Week 48
Time frame · 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
Time frame · At Week 52
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 99 Years
- Sex
- ALL
- Healthy volunteers
- No
Inclusion Criteria: * AHI ≥ 15 on polysomnography at day 1 before randomization. * BMI ≥ 27 kg/m\^2 at screening. * History of at least 1 unsuccessful attempt at weight loss by diet and exercise. * On positive airway pressure (PAP) therapy for at least 3 consecutive months before screening and plan to continue PAP therapy during the trial. Exclusion Criteria: * Had any previous or planned upper airway surgery for sleep apnea or major ear, nose, or throat surgery. * Significant craniofacial abnormalities that may affect breathing at screening. * Diagnosis of Central Apnea with % of central apneas/hypopneas ≥ 50%, and/or diagnosis of Cheyne Stokes Respiration. * Active device treatment of obstructive sleep apnea other than PAP therapy (eg, oral appliances), or other treatments, that in the opinion of the investigator, may interfere with trial outcomes, unless willing to stop treatment at screening and throughout the trial. * 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. * Have personal circumstances or job-related responsibilities that prevent a 7-day PAP withdrawal before polysomnography testing during the course of the trial.
Study locations
60 registered sites.
Australia · Brazil · Canada · Czechia · France · Germany · Hungary · Japan · Poland · Spain · United States. Showing up to 24 locations stored in the fast local snapshot.
Valley Clinical Trials
Northridge, California, United States
Peninsula Research Associates
Rolling Hills Estates, California, United States
Teradan Clinical Trials
Brandon, Florida, United States
Destiny Research Center
Palmetto Bay, Florida, United States
Clinical Research Center Of Florida
Pompano Beach, Florida, United States
NeuroTrials Research
Atlanta, Georgia, United States
Basil Clinical
Laurelton, New York, United States
Monroe Biomedical Research
Monroe, North Carolina, United States
CTI Clinical Research Center
Cincinnati, Ohio, United States
FutureSearch Trials of Neurology
Austin, Texas, United States
Epic Medical Research - DeSoto
DeSoto, Texas, United States
Sleep Therapy & Research Center
San Antonio, Texas, United States
Northwest Clinical Research Center
Bellevue, Washington, United States
Woolcock Institute of Medical Research
Macquarie Park, New South Wales, Australia
Royal Brisbane and Womens Hospital
Herston, Queensland, Australia
Monash Medical Centre
Clayton, Victoria, Australia
Nucleo de Pesquisa do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, Brazil
Instituto de Pesquisa Clinica de Campinas - Ipecc
Campinas, São Paulo, Brazil
CPQuali Pesquisa Clinica Ltda
São Paulo, São Paulo, Brazil
Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo Hcfmusp
São Paulo, São Paulo, Brazil
Centro Paulista de Investigacao Clinica Cepic
São Paulo, Brazil
CaRe Clinic
Calgary, Alberta, Canada
Aggarwal and Associates Ltd
Brampton, Ontario, Canada
Wharton Medical Clinic
Hamilton, Ontario, Canada
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
Related trials
More studies on Maridebart cafraglutide.
NCT IDStudyPhase / statusEnrollmentUpdated
Evaluating the Impact of Maridebart Cafraglutide on Cardiovascular Outcomes in Participants With Atherosclerotic Cardiovascular Disease and Overweight or Obesity
Amgen · Atherosclerotic Cardiovascular Disease · Overweight
Phase 3
Recruiting
12,800
2026-07
Efficacy, Safety and Tolerability of Switching From Glucagon-like Peptide-1 Receptor Agonists (GLP-1RA) to Maridebart Cafraglutide in Adults With Obesity or Overweight (MARITIME-SWITCH)
Amgen · Obesity or Overweight
Phase 3
Recruiting
300
2026-07
A Trial to Assess Bioavailability of AMG 133 in Participants With Overweight or Obesity
Amgen · Overweight and Obesity
Phase 1
Completed
154
2026-07
Effect of Maridebart Cafraglutide on How Oral Contraceptives Are Absorbed and Processed in the Body in Postmenopausal Female Participants Living With Overweight or Obesity
Amgen · Overweight · Obesity
Phase 1
Active, not recruiting
49
2026-07
A Trial to Compare the Extent to Which Maridebart Cafraglutide (AMG 133) is Made Available in the Body When Administered Using Two Subcutaneous Presentations
Amgen · Overweight and Obesity
Phase 1
Completed
349
2026-07
Extension Trial to Evaluate the Long-term Efficacy, Safety, and Tolerability of Maridebart Cafraglutide (MARITIME-2-EXTENSION)
Amgen · Obesity · Overweight
Phase 3
Not yet recruiting
950
2026-07
Extension Trial to Evaluate the Long-term Efficacy, Safety, and Tolerability of Maridebart Cafraglutide (MARITIME-1-EXTENSION)
Amgen · Obesity · Overweight
Phase 3
Not yet recruiting
3,200
2026-07
Maridebart Cafraglutide in Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Obesity
Amgen · Heart Failure With Preserved Ejection Fraction · Heart Failure With Mildly Reduced Ejection Fraction
Phase 3
Recruiting
5,056
2026-07
Related PeptideStat pages
Put the record in context.
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.