Clinical trial Recruiting at 6 sites Phase 3 Interventional Ages 18 and up

Berobenatide in adults with sleep apnea and obesity using a PAP machine

Official title: 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)

Run by Pfizer · NCT07823608 · Data updated 2026-11-12

This study tests berobenatide vs. placebo in adults with moderate to severe obstructive sleep apnea and overweight/obesity who use a PAP device.

Quick facts

PhasePhase 3
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment258 (estimated)
SponsorPfizer
Industry-sponsored
Locations8 sites (Cullman, Alabama and 7 other locations)
StatusRecruiting
StartedSeptember 17, 2026
Main results expectedApril 30, 2028
Study endsJune 18, 2028
Registry record updatedNovember 5, 2026
Trial IDNCT07823608 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults 18 years or older with BMI ≥27 kg/m², diagnosed moderate to severe OSA, and ongoing PAP therapy.

Probably not a fit

Individuals who do not meet BMI, OSA severity, or PAP use criteria, or who have exclusion conditions (e.g., diabetes, pancreatitis, certain cancer risks) may not benefit from the treatment.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 3 interventional trial evaluating the safety and effects of berobenatide given as a monthly subcutaneous injection. Adults with moderate to severe obstructive sleep apnea and BMI ≥27 kg/m² who are using PAP therapy are eligible and will be randomly assigned to berobenatide or placebo. The study includes in-clinic visits, sleep studies, and questionnaires to assess outcomes, with some doses potentially administered at home after training. The trial is sponsored by Pfizer and conducted at several sites in the United States.

Why it matters

Potential benefit: If successful, berobenatide could improve sleep apnea symptoms or related health parameters in patients who are overweight and use PAP therapy.

How similar studies have gone: Previous studies of similar injectable therapies in obesity-related sleep disorders have shown variable results, making this trial important to determine efficacy and safety in this population.

Who can join: the full rules

Show full inclusion / exclusion 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).

Where it's running

  • Cullman Clinical Trials
    Cullman, Alabama, United States
    Recruiting
  • Preferred Research Partners, Inc.
    Little Rock, Arkansas, United States
    Recruiting
  • Probe Clinical Research Corporation
    Riverside, California, United States
    Recruiting
  • DM Clinical Research
    Bradenton, Florida, United States
    Recruiting
  • Headlands Research - Twin Cities
    Maplewood, Minnesota, United States
    Recruiting
  • Velocity Clinical Research, Dallas
    Dallas, Texas, United States
    Recruiting
Show 2 more locations
  • Revive Research Institute, Inc.
    Southfield, Michigan, United States
    Not yet recruiting
  • DM Clinical Research
    Tomball, Texas, United States
    Not yet recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.