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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)

ConditionsApneaSleep DisordersOverweight and/or Obesity
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorPfizer

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Berobenatide

    Drug

    By Subcutaneous Injection

  • Placebo

    Other intervention

    By Subcutaneous Injection

Treatment groups

258 Participants
are divided into 2 treatment groups
Group A: Treatment ArmExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change From Baseline in Apnea-Hypopnea Index (AHI)

Time frame
baseline, Week 52

Secondary outcomes

1

Percent Change From Baseline in Body Weight

Time frame
Baseline, Week 52
2

Change From Baseline in High-Sensitivity C-Reactive Protein (hs-CRP)

Time frame
Baseline , week 52
3

Percent change from baseline in AHI

Time frame
Baseline, week 52
4

Percentage of participants with ≥ 50% AHI reduction

Time frame
baseline ,week 52

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Pfizer

Lead sponsor

Source ClinicalTrials.gov
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