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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)

Sponsor: Pfizer • ClinicalTrials.gov ID: NCT07823608

Registry updated: 2026-10-13

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Description

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.

Interventions

Berobenatide (Drug)
By Subcutaneous Injection
Placebo (Other)
By Subcutaneous Injection

Eligibility criteria

Inclusion Criteria: * Adults aged 18 years or older * Body mass index (BMI) ≥27 kg/m² at screening * Previously diagnosed with moderate to severe obstructive sleep apnea (OSA) * Ongoing positive airway pressure (PAP) therapy for obstructive sleep apnea that is expected to continue during the study. Exclusion Criteria: * Self-reported body weight change of more than 5% within 90 days prior to screening * Diagnosis of any type of diabetes (resolved gestational diabetes is permitted) * History of acute or chronic pancreatitis * Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN 2) Sleep-disordered breathing conditions other than obstructive sleep apnea that could interfere with study assessments or interpretation of results (eg, central sleep apnea, mixed sleep apnea, Cheyne-Stokes respiration, obesity hypoventilation syndrome, or significant craniofacial abnormalities).

Conditions

Apnea Sleep Disorders Overweight and/or Obesity

Locations

Cullman Clinical Trials — Cullman, Alabama, United States
Probe Clinical Research Corporation — Riverside, California, United States
DM Clinical Research — Bradenton, Florida, United States
Headlands Research - Twin Cities — Maplewood, Minnesota, United States
Velocity Clinical Research, Dallas — Dallas, Texas, United States
DM Clinical Research — Tomball, Texas, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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