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Compares treatment options for Obesity
Official title Maridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea on Positive Airway Pressure Therapy
ClinicalTrials.gov ID: NCT07225686
What this study is testing
What is Maridebart cafraglutide?
Maridebart cafraglutide is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for obesity.
Also referred to as AMG 133.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 99
You may be able to join if
- 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.
You likely can't join if
- 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...
- Respiratory diseases such as obesity hypoventilation syndrome or daytime hypercapnia, or neuromuscular diseases such as myasthenia gravis or other...
- Have personal circumstances or job-related responsibilities that prevent a 7-day PAP withdrawal before polysomnography testing during the course of...
The study team makes the final eligibility decision.
Where it's taking place
- Northridge, California, United States
- Rolling Hills Estates, California, United States
- Brandon, Florida, United States
- Palmetto Bay, Florida, United States
- Pompano Beach, Florida, United States
- Atlanta, Georgia, United States
- Laurelton, New York, United States
- Monroe, North Carolina, United States
- Cincinnati, Ohio, United States
- Austin, Texas, United States
- DeSoto, Texas, United States
- San Antonio, Texas, United States
- Bellevue, Washington, United States
- Macquarie Park, New South Wales, Australia
- Herston, Queensland, Australia
- Clayton, Victoria, Australia
- Porto Alegre, Rio Grande do Sul, Brazil
- Campinas, São Paulo, Brazil
- São Paulo, São Paulo, Brazil
- São Paulo, Brazil
+ 38 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Northridge, California, United States; Rolling Hills Estates, California, United States; Brandon, Florida, United States; Palmetto Bay, Florida, United States; Pompano Beach, Florida, United States; Atlanta, Georgia, United States and 52 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.