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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 Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2) (VESPER-OSA 2)

4. november 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 NOT RECEIVING POSITIVE AIRWAY PRESSURE THERAPY (VESPER-OSA 2)

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 are not using 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 unable or unwilling 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

Rekruttering

Forhold

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

Studiesteder

  • Forente stater
    • Alabama
      • Cullman, Alabama, Forente stater, 35055
        • Rekruttering
        • Cullman Clinical Trials
    • Florida
      • Bradenton, Florida, Forente stater, 34209
        • Rekruttering
        • DM Clinical Research-Bradenton
    • Minnesota
      • Maplewood, Minnesota, Forente stater, 55109
        • Rekruttering
        • Headlands Research - Twin Cities
    • Texas
      • Tomball, Texas, Forente stater, 77375
        • Har ikke rekruttert ennå
        • DM Clinical Research-Tomball

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

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

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)
  • Unable or unwilling to use positive airway pressure (PAP) therapy, and no use of PAP therapy for at least 4 weeks prior to screening

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: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Berobenatide

Participants receive berobenatide by subcutaneous injection.
Legemiddel: Berobenatide

Subcutaneous injection

Andre navn:
  • PF-08653944
  • MET097
Placebo komparator: Placebo

Participants receive volume-matched placebo
Legemiddel: Placebo

Volume-matched subcutaneous placebo.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change From Baseline in Apnea-Hypopnea Index
Tidsramme: Baseline, Week 52

Apnea-Hypopnea Index is the number of apnea and hypopnea events per hour of sleep, assessed by polysomnography.
Baseline, Week 52

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change From Baseline in Body Weight
Tidsramme: Baseline, Week 52
Baseline, Week 52
Change From Baseline in Waist Circumference
Tidsramme: Baseline, Week 52
Baseline, Week 52
Percent Change From Baseline in Body Weight
Tidsramme: Baseline, Week 52
Baseline, Week 52
Percentage of Participants With Improvement in Patient Global Impression of Severity (PGI-S) Sleepiness Category
Tidsramme: Week 52
Week 52
Percentage of Participants With Improvement in Patient Global Impression of Severity (PGI-S) Fatigue Category
Tidsramme: Week 52
Week 52
Percentage of Participants Reporting Improvement in Patient Global Impression of Change (PGI-C) Sleepiness
Tidsramme: Week 52
Week 52
Percentage of Participants Reporting Improvement in Patient Global Impression of Change (PGI-C) Fatigue
Tidsramme: Week 52
Week 52
Percentage of Participants Reporting Improvement in Patient Global Impression of Change (PGI-C) Sleep Quality
Tidsramme: Week 52
Week 52
Percentage of Participants Reporting Improvement in Patient Global Impression of Change (PGI-C) Snoring
Tidsramme: Week 52
Week 52
Number of participants with Treatment-Emergent Adverse Event (TEAE)
Tidsramme: Week 52
Week 52
Number of participants with Serious Adverse Event (SAE)
Tidsramme: Week 52
Week 52
Number of participants with Adverse event (AE) leading to permanent discontinuation from study intervention or study
Tidsramme: Week 52
Week 52
Number of participants with Adverse Events of Special Interest (AESI)
Tidsramme: Week 52
Week 52
Number of participants with clinical laboratory abnormalities
Tidsramme: Week 52
Week 52
Change From Baseline in Low-density lipoprotein cholesterol (LDL-C)
Tidsramme: Baseline, week 52
Baseline, week 52
Change From Baseline in High-Sensitivity C-Reactive Protein
Tidsramme: Baseline, Week 52
Baseline, Week 52
Percent Change From Baseline in Apnea-Hypopnea Index
Tidsramme: Baseline, Week 52
Baseline, Week 52
Percentage of Participants With at Least 50% Reduction in Apnea-Hypopnea Index
Tidsramme: Week 52
Week 52
Change From Baseline in Sleep-Apnea-Specific Hypoxic Burden (SASHB)
Tidsramme: Baseline, Week 52
Baseline, Week 52
Percentage of Participants With Obstructive Sleep Apnea Remission or Mild Non-Symptomatic Obstructive Sleep Apnea
Tidsramme: Week 52
Week 52
Change From Baseline in Systolic Blood Pressure
Tidsramme: Baseline, Week 52
Baseline, Week 52
Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep-Related Impairment 8a T-Score
Tidsramme: Baseline, Week 52
Baseline, Week 52
Change From Baseline in PROMIS Sleep Disturbance 8b T-Score
Tidsramme: Baseline, Week 52
Baseline, Week 52
Percentage of Participants with AHI <5
Tidsramme: Week 52
Week 52
Percentage of Participants with AHI 5-14 with ESS (Epworth Sleepiness Scale) ≤10
Tidsramme: Week 52
Week 52
Percentage of participants with AHI less then 15
Tidsramme: Week 52
Week 52
Change From Baseline in Epworth Sleepiness Scale Total Score
Tidsramme: Baseline, Week 52
Baseline, Week 52
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
Baseline, Week 52
Change From Baseline in IWQOL-Lite-CT Physical Composite Score
Tidsramme: Baseline, Week 52
Baseline, Week 52
Change From Baseline in IWQOL-Lite-CT Psychosocial Composite Score
Tidsramme: Baseline, Week 52
Baseline, Week 52
Change From Baseline in IWQOL-Lite-CT Total Score
Tidsramme: Baseline, Week 52

Score ranges from 0 to 100; higher scores indicate better quality of life.
Baseline, Week 52
Change From Baseline in Body Mass Index
Tidsramme: Baseline, Week 52
Baseline, Week 52
Change From Baseline in Neck Circumference
Tidsramme: Baseline, Week 52
Baseline, Week 52
Change From Baseline in Short Form 36-Item (SF-36)
Tidsramme: Baseline, Week 52
Baseline, Week 52
Percentage of Participants With Improvement in Patient Global Impression of Severity (PGI-S) Snoring Category
Tidsramme: Week 52
Week 52
Change From Baseline in EuroQol 5-Dimension, 5-Level (EQ-5D-5L) Index Score
Tidsramme: Baseline, Week 52
Baseline, Week 52
Change From Baseline in EuroQol-visual analog scale (EQ-VAS) Score
Tidsramme: Baseline, Week 52
Baseline, Week 52
Change From Baseline in WPAI:GH Presenteeism Score
Tidsramme: Baseline, Week 52
Baseline, Week 52
Change From Baseline in WPAI:GH Work Productivity Loss Score
Tidsramme: Baseline, Week 52
Baseline, Week 52
Change From Baseline in WPAI:GH Activity Impairment Score
Tidsramme: Baseline, Week 52
Baseline, Week 52
Change From Baseline in Diastolic Blood Pressure
Tidsramme: Baseline, Week 52
Baseline, Week 52
Change From Baseline in Total Cholesterol
Tidsramme: Baseline, Week 52
Baseline, Week 52
Change From Baseline in High-density lipoprotein cholesterol (HDL-C)
Tidsramme: Baseline, Week 52
Baseline, Week 52
Change From Baseline in Non-HDL Cholesterol
Tidsramme: Baseline, Week 52
Baseline, Week 52
Change From Baseline in Very low-density lipoprotein cholesterol (VLDL) Cholesterol
Tidsramme: Baseline, Week 52
Baseline, Week 52
Change From Baseline in Triglycerides
Tidsramme: Baseline, Week 52
Baseline, Week 52

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Pfizer

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 (Faktiske)

19. oktober 2026

Primær fullføring (Antatt)

1. juni 2028

Studiet fullført (Antatt)

20. juli 2028

Datoer for studieregistrering

Først innsendt

9. oktober 2026

Først innsendt som oppfylte QC-kriteriene

15. oktober 2026

Først lagt ut (Faktiske)

19. oktober 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

6. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

4. november 2026

Sist bekreftet

1. november 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • C6491021
  • VESPER-OSA 2 (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

produkt produsert i og eksportert fra USA

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere