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)
11. september 2026 oppdatert av: Pfizer
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)
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.
Studieoversikt
Status
Har ikke rekruttert ennå
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
258
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Pfizer CT.gov Call Center
- Telefonnummer: 1-800-718-1021
- E-post: ClinicalTrials.gov_Inquiries@pfizer.com
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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).
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Placebo komparator: Placebo
Deltakerne vil motta tilsvarende placebo ved subkutan injeksjon.
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Ved subkutan injeksjon
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Eksperimentell: Treatment Arm
Participants will receive berobenatide by Subcutaneous Injection.
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By Subcutaneous Injection
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Change From Baseline in Apnea-Hypopnea Index (AHI)
Tidsramme: baseline, Week 52
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baseline, Week 52
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Percent Change From Baseline in Body Weight
Tidsramme: Baseline, Week 52
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Baseline, Week 52
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Change From Baseline in High-Sensitivity C-Reactive Protein (hs-CRP)
Tidsramme: Baseline , week 52
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Baseline , week 52
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Percent change from baseline in AHI
Tidsramme: Baseline, week 52
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Baseline, week 52
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Percentage of participants with ≥ 50% AHI reduction
Tidsramme: baseline ,week 52
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baseline ,week 52
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Change From Baseline in Sleep Apnea Specific Hypoxic Burden (SASHB)
Tidsramme: Baseline, week 52
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Baseline, week 52
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Percentage of participants who achieve either AHI <5 events/hour or AHI 5-14 events/hour with Epworth Sleepiness Scale (ESS) score ≤10
Tidsramme: baseline, week 52
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baseline, week 52
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Change From Baseline in Systolic Blood Pressure (SBP)
Tidsramme: Baseline, week 52
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Baseline, week 52
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Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep-Related Impairment 8a T-score
Tidsramme: baseline, week 52
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Change from baseline in the Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep-Related Impairment Short Form 8a T-score.
Higher scores indicate greater sleep-related impairment..
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baseline, week 52
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Change From Baseline in PROMIS Sleep Disturbance 8b T-score
Tidsramme: Baseline, week 52
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Change from baseline in the PROMIS Sleep Disturbance Short Form 8b T-score.
Higher scores indicate greater sleep disturbance.
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Baseline, week 52
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Change from baseline in Impact of Weight on Quality of Life-Lite Clinical Trials (IWQOL-Lite-CT) Physical Function Composite Score
Tidsramme: Baseline, week 52
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Baseline, week 52
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Percentage of participants with apnea-hypopnea events less then 15
Tidsramme: Baseline, week 52
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Baseline, week 52
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Change From Baseline in Epworth Sleepiness Scale Total Score
Tidsramme: Baseline, week 52
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Baseline, week 52
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Change from baseline in IWQoL-Lite-CT physical function composite score
Tidsramme: Baseline, week 52
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Baseline, week 52
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Change From Baseline in IWQOL-Lite-CT Physical Composite Score
Tidsramme: Baseline, week 52
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Baseline, week 52
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Change from baseline in IWQoL-Lite-CT Psychosocial Composite Score
Tidsramme: Baseline, week 52
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Baseline, week 52
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Change From Baseline in IWQoL-Lite-CT Total Score
Tidsramme: Baseline, week 52
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Baseline, week 52
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Change From Baseline in Body Weight
Tidsramme: Baseline, week 52
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Baseline, week 52
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Change From Baseline in Body Mass Index (BMI)
Tidsramme: Baseline, week 52
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Baseline, week 52
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Change From Baseline in Waist Circumference
Tidsramme: Baseline, week 52
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Baseline, week 52
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Change From Baseline in Neck Circumference
Tidsramme: Baseline, wee 52
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Baseline, wee 52
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Change From Baseline in Short Form 36-Item ((SF-36)
Tidsramme: Baseline, week 52
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Baseline, week 52
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Percentage of Participants With Improvement in Patient Global Impression of Severity (PGI-S) Sleepiness Category
Tidsramme: Week 52
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Week 52
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Percentage of Participants With Improvement in Patient Global Impression of Severity (PGI-S) Fatigue Category
Tidsramme: Week 52
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Week 52
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Percentage of Participants With Improvement in Patient Global Impression of Severity (PGI-S) Snoring Category
Tidsramme: Baseline, wee 52
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Baseline, wee 52
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Percentage of Participants Reporting Improvement in Patient Global Impression of Change (PGI-C) Sleepiness
Tidsramme: Week 52
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Week 52
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Percentage of Participants Reporting Improvement in Patient Global Impression of Change (PGI-C) Fatigue
Tidsramme: Week 52
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Week 52
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Percentage of Participants Reporting Improvement in Patient Global Impression of Change (PGI-C) Sleep Quality
Tidsramme: Week 52
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Week 52
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Percentage of Participants Reporting Improvement in Patient Global Impression of Change (PGI-C) Snoring
Tidsramme: Week 52
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Week 52
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Change From Baseline in EuroQol 5-Dimension, 5-Level (EQ-5D-5L) Index Score
Tidsramme: Baseline, week 52
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Baseline, week 52
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Change From Baseline in EuroQol-visual analog scale (EQ-VAS) Score
Tidsramme: Baseline, week 52
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Baseline, week 52
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Change From Baseline in Work Productivity and Activity Impairment - General Health (WPAI:GH) Absenteeism Score
Tidsramme: Baseline, week 52
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Baseline, week 52
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Change From Baseline in WPAI:GH Presenteeism Score
Tidsramme: Baseline, week 52
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Baseline, week 52
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Change From Baseline in WPAI:GH Work Productivity Loss Score
Tidsramme: Baseline, week 52
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Baseline, week 52
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Change From Baseline in WPAI:GH Activity Impairment Score
Tidsramme: Baseline, week 52
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Baseline, week 52
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Number of participants with Treatment-Emergent Adverse Event (TEAE)
Tidsramme: Week 52
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Week 52
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Number of participants with Serious Adverse Event (SAE)
Tidsramme: Week 52
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Week 52
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Number of participants with Adverse event (AE) leading to permanent discontinuation from study intervention or study
Tidsramme: Week 52
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Week 52
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Number of participants with Adverse Events of Special Interest (AESI)
Tidsramme: Week 52
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Week 52
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Number of participants with clinical laboratory abnormalities
Tidsramme: Week 52
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Week 52
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Change From Baseline in Diastolic Blood Pressure
Tidsramme: Baseline, week 52
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Baseline, week 52
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Change From Baseline in Total Cholesterol
Tidsramme: Baseline, week 52
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Baseline, week 52
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Change From Baseline in High-density lipoprotein cholesterol (HDL-C)
Tidsramme: Baseline, week 52
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Baseline, week 52
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Change From Baseline in Low-density lipoprotein cholesterol (LDL-C)
Tidsramme: Baseline, week 52
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Baseline, week 52
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Change From Baseline in Non-HDL Cholesterol
Tidsramme: Baseline, week 52
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Baseline, week 52
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Change From Baseline in Very low-density lipoprotein cholesterol (VLDL) Cholesterol
Tidsramme: Baseline, week 52
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Baseline, week 52
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Change From Baseline in Triglycerides
Tidsramme: Baseline, week 52
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Baseline, week 52
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: Pfizer CT.gov Call Center, Pfizer
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Hjelpsomme linker
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
19. september 2026
Primær fullføring (Antatt)
19. juni 2028
Studiet fullført (Antatt)
19. juni 2028
Datoer for studieregistrering
Først innsendt
11. september 2026
Først innsendt som oppfylte QC-kriteriene
11. september 2026
Først lagt ut (Faktiske)
16. september 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
16. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
11. september 2026
Sist bekreftet
1. september 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Nevrologiske manifestasjoner
- Sykdommer i nervesystemet
- Psykiske lidelser
- Ernæringsforstyrrelser
- Overernæring
- Kroppsvekt
- Sykdommer i luftveiene
- Respirasjonsforstyrrelser
- Tegn og symptomer, luftveier
- Søvnforstyrrelser, iboende
- Dyssomnier
- Patologiske tilstander, tegn og symptomer
- Ernæringsmessige og metabolske sykdommer
- Tegn og symptomer
- Overvektig
- Overvekt
- Søvnapné syndromer
- Apné
- Søvnvåkenforstyrrelser
Andre studie-ID-numre
- C6491020
- VESPER-OSA 1 (Annen identifikator: Alias Study Number)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
Pfizer will provide access to individual de-identified participant data and related study documents (e.g.
protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions.
Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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