Not yet taking people in GermanyPhase 3
Tests monthly berobenatide for sleep apnea in adults with overweight or obesity
Tests a once-monthly medicine against placebo in adults with sleep apnea and excess weight.
Key facts
- Who runs it
- Pfizer Inc.
- Where
- Bamberg, Bochum, Duesseldorf, Hamburg, Hanover, Ibbenbüren, Karlsruhe, Oldenburg in Holstein, and Schleswig, GermanySee the 9 sites
- Trial code
- Registry title
- 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)
- Status
- Not yet recruiting
- Phase
- Phase 3
- People taking part
- 30 people, planned
- Starts
- 7 Dec 2026
- Expected to end
- 1 Sept 2028
- Type of study
- Interventional
- Record updated
- 9 November 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with moderate to severe obstructive sleep apnea who are overweight or obese and already use a breathing machine (PAP).
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Moderate to severe obstructive sleep apnea, with BMI of 27 kg/m² or more at screening.
- Earlier treatment
- Must be using positive airway pressure (PAP) therapy for sleep apnea, expected to continue during the study.
Main reasons for not taking part
- Body weight change of more than 5% in the 90 days before screening (self-reported)
- Any type of diabetes (resolved gestational diabetes is allowed)
- History of acute or chronic pancreatitis
- Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2
- Other sleep conditions or treatments that could affect breathing tests, such as prior airway surgery or non-PAP sleep apnea treatments
The registry criteria, word for word
Show all 9 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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)
Where in Germany
- CIMS Studienzentrum Bamberg GmbHBamberg, GermanyNot yet recruiting
- Siteworks GmbHBochum, GermanyNot yet recruiting
- Schwerpunktpraxis fuer Lungen- und Bronchialheilkunde, Allergologie und SchlafmedizinDuesseldorf, GermanyNot yet recruiting
- Diabeteszentrum Hamburg WestHamburg, GermanyNot yet recruiting
- Siteworks GmbHHanover, GermanyNot yet recruiting
- Gemeinschaftspraxis für Pneumologie, Allergologie und SchlafmedizinIbbenbüren, GermanyNot yet recruiting
- Klinische Forschung Karlsruhe GmbHKarlsruhe, GermanyNot yet recruiting
- R.E.D. Institut fuer medizinische Studien und Fortbildung GmbHOldenburg in Holstein, GermanyNot yet recruiting
- Siteworks GmbHSchleswig, GermanyNot yet recruiting
About the trial
What the trial wants to find out
To demonstrate the superiority of berobenatide QM compared to placebo for reducing apnea‑hypopnea events
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?
Contact the study team: see the registry record
Print a page for my doctorData and sources
- Registry record
- Listed on the EU's official list of trials (CTIS).
- Official title
- 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)
- Plain-language title
- Tests monthly berobenatide for sleep apnea in adults with overweight or obesityGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 10 November 2026.
- Record updated
- 9 November 2026