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A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Use a Breathing Machine (PAP) (VESPER-OSA 1)

StatusRecruiting
PhasePhase 3
SponsorPfizer
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Trial sites expanded: 3 → 6 locations
  2. Minor Study sites: 3 to 5
  3. Notable Recruitment opened Show 4 more changesShow less
    • Trial sites expanded: 0 → 3 locations
    • Primary completion moved earlier from Jun 19, 2028 to Apr 30, 2028
    • Start date changed from estimate of Sep 19, 2026 to Sep 17, 2026
    • Study completion date: Jun 19, 2028 to Jun 18, 2028
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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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 use 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 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 NCT07823608
Lead Sponsor Pfizer
Conditions
(from sponsor)
Apnea, Sleep Disorders, Overweight and/or Obesity
Related terms Apnea, Obesity, Overweight, Sleep Apnea Syndromes, Sleep Wake Disorders
Enrollment 258 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov