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)
Key facts
- Where
- Bamberg, Bochum, Duesseldorf, Hamburg, Hanover, Ibbenbüren, Karlsruhe, Oldenburg in Holstein és Schleswig, NémetországSee the 9 sites
- Phase
- 3. fázis
Where in Németország
- CIMS Studienzentrum Bamberg GmbHBamberg, NémetországToborzás még nem indult
- Siteworks GmbHBochum, NémetországToborzás még nem indult
- Schwerpunktpraxis fuer Lungen- und Bronchialheilkunde, Allergologie und SchlafmedizinDuesseldorf, NémetországToborzás még nem indult
- Diabeteszentrum Hamburg WestHamburg, NémetországToborzás még nem indult
- Siteworks GmbHHanover, NémetországToborzás még nem indult
- Gemeinschaftspraxis für Pneumologie, Allergologie und SchlafmedizinIbbenbüren, NémetországToborzás még nem indult
- Klinische Forschung Karlsruhe GmbHKarlsruhe, NémetországToborzás még nem indult
- R.E.D. Institut fuer medizinische Studien und Fortbildung GmbHOldenburg in Holstein, NémetországToborzás még nem indult
- Siteworks GmbHSchleswig, NémetországToborzás még nem indult
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Pfizer Inc.
- Trial code
- EU 2026-526327-22-00
- Record updated
- 2026. november 9.
- Original description
To demonstrate the superiority of berobenatide QM compared to placebo for reducing apnea‑hypopnea eventsRead full original descriptionShow less
C6491020 - 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)
To demonstrate the superiority of berobenatide QM compared to placebo for reducing apnea‑hypopnea events
Inclusion: Adults aged 18 years or older; Body mass index (BMI) ≥27 kg/m² at screening; Previously diagnosed with moderate to severe obstructive sleep apnea; Ongoing positive airway pressure (PAP) therapy for obstructive sleep apnea that is expected to continue during the study.
Exclusion: Self-reported body weight change of more than 5% within 90 days prior to screening; Sleep related conditions, treatments or disorders that could confound respiratory assessments of OSA including prior airway surgery, non-obstructive sleep apnea syndromes, hypoventilation disorders, non-PAP OSA treatments, significant respiratory/neuromuscular/craniofacial disease, severe insomnia, or other clinically relevant sleep disorders; 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).