Kitahiroshima

Researchers are evaluating the efficacy and safety of eloralintide in adults with moderate-to-severe obstructive sleep apnea who are also overweight or obese. This trial is structured as a master protocol called YDAO, which supports two studies YSA1 for participants who do not use or refuse Positive Airway Pressure PAP therapy, and YSA2 for those who have been on PAP therapy for at least three months and plan to continue it. The study aims to understand how eloralintide affects body weight and sleep apnea severity over time. Participants will be randomly assigned to receive either eloralintide or a placebo through subcutaneous injections once weekly. The study includes two parallel groups reflecting current PAP therapy use. Treatment lasts about 64 weeks, followed by assessments. The design includes double-blinding to compare the effects between intervention and placebo groups. During the study, participants will be closely monitored for changes in body weight and apnea-hypopnea index AHI at baseline and week 64. Additional measurements include blood pressure, triglycerides, inflammation markers, sleep-related impairment scores, and glucose metabolism. Researchers will also track patient-reported outcomes, medication use, and pharmacokinetics. Participation lasts approximately 76 weeks, covering screening, treatment, and follow-up evaluations to ensure safety and collect comprehensive data.

Researchers are evaluating 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 using positive airway pressure PAP therapy and have overweight or obesity. This Phase 3 randomized, double-blind, placebo-controlled trial aims to understand how this treatment affects OSA severity and related health measures in this specific population. Participants will be randomly assigned to receive either maridebart cafraglutide or a placebo, both given as subcutaneous injections. The study treatment is administered throughout the 52-week period. The trial compares these two groups in parallel to assess the effects of the medication against placebo. During the study, participants will undergo various assessments including polysomnography to measure apnea-hypopnea index AHI, body weight monitoring, blood pressure checks, and patient-reported sleep impairment questionnaires. Safety and tolerability will be monitored, and researchers will track changes in markers such as sleep apnea severity, body weight, inflammation, and blood pressure over the 52 weeks of treatment.

Researchers are evaluating the efficacy and safety of maridebart cafraglutide compared to placebo over 52 weeks in adults with obstructive sleep apnea OSA who are receiving positive airway pressure PAP therapy and have overweight or obesity. This Phase 3 trial aims to study the treatment effects in this specific population to improve management of OSA alongside current PAP therapy. Participants are randomly assigned to receive either maridebart cafraglutide or a placebo as subcutaneous injections. The study runs for 52 weeks, during which participants continue their PAP therapy while receiving the study drug or placebo. The trial includes a double-blind design to compare outcomes between the two groups over the treatment period. During the study, participants undergo various assessments including polysomnography to measure the Apnea-Hypopnea Index AHI, body weight measurements, blood pressure, blood tests for cholesterol, insulin, and glucose levels, as well as patient-reported sleep-related outcomes. Researchers monitor treatment-emergent adverse events and drug plasma levels, with evaluations occurring at multiple time points including weeks 24, 48, and 52. The total participation duration extends up to about 100 weeks for safety follow-up and outcome evaluation.