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 opdateret af: 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.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
258
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Pfizer CT.gov Call Center
- Telefonnummer: 1-800-718-1021
- E-mail: ClinicalTrials.gov_Inquiries@pfizer.com
Studiesteder
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Alabama
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Cullman, Alabama, Forenede Stater, 35055
- Rekruttering
- Cullman Clinical Trials
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Florida
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Bradenton, Florida, Forenede Stater, 34209
- Rekruttering
- DM Clinical Research-Bradenton
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Minnesota
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Maplewood, Minnesota, Forenede Stater, 55109
- Rekruttering
- Headlands Research - Twin Cities
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Texas
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Tomball, Texas, Forenede Stater, 77375
- Ikke rekrutterer endnu
- DM Clinical Research-Tomball
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Berobenatide
Participants receive berobenatide by subcutaneous injection. |
Subcutaneous injection
Andre navne:
|
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Placebo komparator: Placebo
Participants receive volume-matched placebo |
Volume-matched subcutaneous placebo. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change From Baseline in Body Weight
Tidsramme: Baseline, Week 52
|
Baseline, Week 52
|
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Change From Baseline in Waist Circumference
Tidsramme: Baseline, Week 52
|
Baseline, Week 52
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Percent Change From Baseline in Body Weight
Tidsramme: Baseline, Week 52
|
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
|
Week 52
|
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Percentage of Participants With Improvement in Patient Global Impression of Severity (PGI-S) Fatigue Category
Tidsramme: Week 52
|
Week 52
|
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Percentage of Participants Reporting Improvement in Patient Global Impression of Change (PGI-C) Sleepiness
Tidsramme: Week 52
|
Week 52
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Percentage of Participants Reporting Improvement in Patient Global Impression of Change (PGI-C) Fatigue
Tidsramme: Week 52
|
Week 52
|
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Percentage of Participants Reporting Improvement in Patient Global Impression of Change (PGI-C) Sleep Quality
Tidsramme: Week 52
|
Week 52
|
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Percentage of Participants Reporting Improvement in Patient Global Impression of Change (PGI-C) Snoring
Tidsramme: Week 52
|
Week 52
|
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Number of participants with Treatment-Emergent Adverse Event (TEAE)
Tidsramme: Week 52
|
Week 52
|
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Number of participants with Serious Adverse Event (SAE)
Tidsramme: Week 52
|
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
|
Week 52
|
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Number of participants with Adverse Events of Special Interest (AESI)
Tidsramme: Week 52
|
Week 52
|
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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
|
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Percentage of Participants With at Least 50% Reduction in Apnea-Hypopnea Index
Tidsramme: Week 52
|
Week 52
|
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Change From Baseline in Sleep-Apnea-Specific Hypoxic Burden (SASHB)
Tidsramme: Baseline, Week 52
|
Baseline, Week 52
|
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Percentage of Participants With Obstructive Sleep Apnea Remission or Mild Non-Symptomatic Obstructive Sleep Apnea
Tidsramme: Week 52
|
Week 52
|
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|
Change From Baseline in Systolic Blood Pressure
Tidsramme: Baseline, Week 52
|
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
|
Baseline, Week 52
|
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Change From Baseline in PROMIS Sleep Disturbance 8b T-Score
Tidsramme: Baseline, Week 52
|
Baseline, Week 52
|
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Percentage of Participants with AHI <5
Tidsramme: Week 52
|
Week 52
|
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Percentage of Participants with AHI 5-14 with ESS (Epworth Sleepiness Scale) ≤10
Tidsramme: Week 52
|
Week 52
|
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Percentage of participants with AHI less then 15
Tidsramme: Week 52
|
Week 52
|
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|
Change From Baseline in Epworth Sleepiness Scale Total Score
Tidsramme: Baseline, Week 52
|
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
|
Baseline, Week 52
|
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Change From Baseline in IWQOL-Lite-CT Physical Composite Score
Tidsramme: Baseline, Week 52
|
Baseline, Week 52
|
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Change From Baseline in IWQOL-Lite-CT Psychosocial Composite Score
Tidsramme: Baseline, Week 52
|
Baseline, Week 52
|
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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
|
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Change From Baseline in Neck Circumference
Tidsramme: Baseline, Week 52
|
Baseline, Week 52
|
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Change From Baseline in Short Form 36-Item (SF-36)
Tidsramme: Baseline, Week 52
|
Baseline, Week 52
|
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Percentage of Participants With Improvement in Patient Global Impression of Severity (PGI-S) Snoring Category
Tidsramme: Week 52
|
Week 52
|
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Change From Baseline in EuroQol 5-Dimension, 5-Level (EQ-5D-5L) Index Score
Tidsramme: Baseline, Week 52
|
Baseline, Week 52
|
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Change From Baseline in EuroQol-visual analog scale (EQ-VAS) Score
Tidsramme: Baseline, Week 52
|
Baseline, Week 52
|
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Change From Baseline in WPAI:GH Presenteeism Score
Tidsramme: Baseline, Week 52
|
Baseline, Week 52
|
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Change From Baseline in WPAI:GH Work Productivity Loss Score
Tidsramme: Baseline, Week 52
|
Baseline, Week 52
|
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Change From Baseline in WPAI:GH Activity Impairment Score
Tidsramme: Baseline, Week 52
|
Baseline, Week 52
|
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Change From Baseline in Diastolic Blood Pressure
Tidsramme: Baseline, Week 52
|
Baseline, Week 52
|
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Change From Baseline in Total Cholesterol
Tidsramme: Baseline, Week 52
|
Baseline, Week 52
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Change From Baseline in High-density lipoprotein cholesterol (HDL-C)
Tidsramme: Baseline, Week 52
|
Baseline, Week 52
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Change From Baseline in Non-HDL Cholesterol
Tidsramme: Baseline, Week 52
|
Baseline, Week 52
|
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Change From Baseline in Very low-density lipoprotein cholesterol (VLDL) Cholesterol
Tidsramme: Baseline, Week 52
|
Baseline, Week 52
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Change From Baseline in Triglycerides
Tidsramme: Baseline, Week 52
|
Baseline, Week 52
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Pfizer CT.gov Call Center, Pfizer
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
19. oktober 2026
Primær færdiggørelse (Anslået)
1. juni 2028
Studieafslutning (Anslået)
20. juli 2028
Datoer for studieregistrering
Først indsendt
9. oktober 2026
Først indsendt, der opfyldte QC-kriterier
15. oktober 2026
Først opslået (Faktiske)
19. oktober 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
6. november 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
4. november 2026
Sidst verificeret
1. november 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Neurologiske manifestationer
- Sygdomme i nervesystemet
- Psykiske lidelser
- Luftvejssygdomme
- Respirationsforstyrrelser
- Tegn og symptomer, luftveje
- Søvnforstyrrelser, iboende
- Dyssomnier
- Respiratoriske lyde
- Patologiske tilstande, tegn og symptomer
- Tegn og symptomer
- Parasomnier
- Søvnapnø syndromer
- Søvnapnø, obstruktiv
- Apnø
- Søvnvågningsforstyrrelser
- Snorken
- Dyspnø
- Lidelser af overdreven somnolens
Andre undersøgelses-id-numre
- C6491021
- VESPER-OSA 2 (Anden identifikator: Alias Study Number)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (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.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
produkt fremstillet i og eksporteret fra U.S.A.
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .