NCT07823608 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)
| NCT ID | NCT07823608 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Pfizer |
| Condition | Apnea |
| Study Type | INTERVENTIONAL |
| Enrollment | 258 participants |
| Start Date | 2026-09-17 |
| Primary Completion | 2028-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 258 participants in total. It began in 2026-09-17 with a primary completion date of 2028-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
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).
Contact & Investigator
Pfizer CT.gov Call Center
STUDY DIRECTOR
Pfizer
Frequently Asked Questions
Who can join the NCT07823608 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Apnea. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07823608 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 258 participants.
Is NCT07823608 currently recruiting?
Yes, NCT07823608 is actively recruiting participants. Contact the research team at ClinicalTrials.gov_Inquiries@pfizer.com for enrollment information.
Where is the NCT07823608 trial being conducted?
This trial is being conducted at Cullman, United States, Little Rock, United States, Riverside, United States, Bradenton, United States and 4 additional locations.
Who is sponsoring the NCT07823608 clinical trial?
NCT07823608 is sponsored by Pfizer. The principal investigator is Pfizer CT.gov Call Center at Pfizer. The trial plans to enroll 258 participants.