NCT07823608RecruitingPhase 3
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)
A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF ONCE-MONTHLY BEROBENATIDE IN ADULTS WITH OBSTRUCTIVE SLEEP APNEA AND OVERWEIGHT OR OBESITY RECEIVING POSITIVE AIRWAY PRESSURE THERAPY (VESPER-OSA 1)
Source: ClinicalTrials.gov · Last updated 13 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 258 (estimated)
- First submitted
- 11 Sept 2026
- Start date
- 17 Sept 2026
- Primary completion date
- 30 Apr 2028
- Lead sponsor
- Pfizer
- Diseases
- Obesity
- NCT number
- NCT07823608
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 258
- From 17 Sept 2026 to the primary completion date, 30 Apr 2028
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Self-reported body weight change of more than 5% within 90 days prior to screening
Other illness
- 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).
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| DM Clinical Research Coordinator of this site? Confirm its status | Bradenton | United States | Recruiting |
| Cullman Clinical Trials Coordinator of this site? Confirm its status | Cullman | United States | Not yet recruiting |
| Velocity Clinical Research, Dallas Coordinator of this site? Confirm its status | Dallas | United States | Not yet recruiting |
| Headlands Research-Twin Cities Coordinator of this site? Confirm its status | Maplewood | United States | Recruiting |
| Probe Clinical Research Corporation Coordinator of this site? Confirm its status | Riverside | United States | Recruiting |
| DM Clinical Research Coordinator of this site? Confirm its status | Tomball | United States | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.