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)

Condition(s) studied

Investigational drug(s) / intervention(s)

Berobenatide: Subcutaneous injection

Placebo: Volume-matched subcutaneous placebo.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Change From Baseline in Apnea-Hypopnea Index — Baseline, Week 52
  Apnea-Hypopnea Index is the number of apnea and hypopnea events per hour of sleep, assessed by polysomnography.

Trial sites (2)

More Pfizer trials in the USA

Other trials for the same condition