2026-526327-22-00Not yet recruitingPhase 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)
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)
Source: EU CTIS (euclinicaltrials.eu) · Last updated 9 Nov 2026
Brief summary (registry, in English)
To demonstrate the superiority of berobenatide QM compared to placebo for reducing apnea‑hypopnea events
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 10 Aug 2026
- Start date
- 7 Dec 2026
- Lead sponsor
- Pfizer Inc.
- Diseases
- Obesity
- EU CT number
- 2026-526327-22-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 30
- 9 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
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
Read by machine on 10 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) 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
- 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
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)
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
- 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 (9)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CIMS Studienzentrum Bamberg GmbH | Bamberg | Germany | Not yet recruiting |
| Siteworks GmbH | Bochum | Germany | Not yet recruiting |
| Schwerpunktpraxis fuer Lungen- und Bronchialheilkunde, Allergologie und Schlafmedizin | Duesseldorf | Germany | Not yet recruiting |
| Diabeteszentrum Hamburg West | Hamburg | Germany | Not yet recruiting |
| Siteworks GmbH | Hanover | Germany | Not yet recruiting |
| Gemeinschaftspraxis für Pneumologie, Allergologie und Schlafmedizin | Ibbenbüren | Germany | Not yet recruiting |
| Klinische Forschung Karlsruhe GmbH | Karlsruhe | Germany | Not yet recruiting |
| R.E.D. Institut fuer medizinische Studien und Fortbildung GmbH | Oldenburg in Holstein | Germany | Not yet recruiting |
| Siteworks GmbH | Schleswig | Germany | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.