A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)

Study acronym: VESPER-OSA 2
StatusNot Yet Recruiting
PhasePhase 3
SponsorPfizer
Started

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Record History

  1. Minor Study First Submitted
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3,888 trials monitored
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This study is being done to learn about the safety and effects of a study medicine called berobenatide (bear-oh-BEN-uh-tide). The study will see if berobenatide can help adults with breathing problems during sleep (obstructive sleep apnea \[OSA\]) and overweight or obesity who are not using a breathing machine (positive airway pressure \[PAP\] machine). People may be able to take part if they are adults with moderate to severe OSA, have overweight or obesity, and have been unable or unwilling using PAP therapy before joining the study. Participants will be assigned by chance to receive either berobenatide or a placebo (a treatment that looks like the study medicine but contains no active medicine). The study treatment will be given as an injection under the skin approximately once a month. Participants will receive study treatment at study sites and may administer some doses at home after receiving training. During the study, participants will attend study visits, undergo sleep studies, complete questionnaires, and have health assessments performed. Researchers will compare the effects of berobenatide and placebo on sleep apnea, body weight, and other health measures.
Trial Details
NCT Number NCT07881757
Lead Sponsor Pfizer
Conditions
(from sponsor)
Apnea, Sleep Disorders, Overweight and/or Obesity
Related terms Apnea, Disorders of Excessive Somnolence, Dyspnea, Parasomnias, Sleep Apnea Syndromes, Sleep Apnea, Obstructive, Sleep Wake Disorders, Snoring
Enrollment 258 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov