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 uppdaterad 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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
258
Fas
- Fas 3
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Pfizer CT.gov Call Center
- Telefonnummer: 1-800-718-1021
- E-post: ClinicalTrials.gov_Inquiries@pfizer.com
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Placebo-jämförare: Placebo
Deltagarna kommer att få matchande placebo genom subkutan injektion.
|
Genom subkutant injektion
|
|
Experimentell: Treatment Arm
Participants will receive berobenatide by Subcutaneous Injection.
|
By Subcutaneous Injection
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Change From Baseline in Apnea-Hypopnea Index (AHI)
Tidsram: baseline, Week 52
|
baseline, Week 52
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Percent Change From Baseline in Body Weight
Tidsram: Baseline, Week 52
|
Baseline, Week 52
|
|
|
Change From Baseline in High-Sensitivity C-Reactive Protein (hs-CRP)
Tidsram: Baseline , week 52
|
Baseline , week 52
|
|
|
Percent change from baseline in AHI
Tidsram: Baseline, week 52
|
Baseline, week 52
|
|
|
Percentage of participants with ≥ 50% AHI reduction
Tidsram: baseline ,week 52
|
baseline ,week 52
|
|
|
Change From Baseline in Sleep Apnea Specific Hypoxic Burden (SASHB)
Tidsram: Baseline, week 52
|
Baseline, week 52
|
|
|
Percentage of participants who achieve either AHI <5 events/hour or AHI 5-14 events/hour with Epworth Sleepiness Scale (ESS) score ≤10
Tidsram: baseline, week 52
|
baseline, week 52
|
|
|
Change From Baseline in Systolic Blood Pressure (SBP)
Tidsram: Baseline, week 52
|
Baseline, week 52
|
|
|
Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep-Related Impairment 8a T-score
Tidsram: baseline, week 52
|
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..
|
baseline, week 52
|
|
Change From Baseline in PROMIS Sleep Disturbance 8b T-score
Tidsram: Baseline, week 52
|
Change from baseline in the PROMIS Sleep Disturbance Short Form 8b T-score.
Higher scores indicate greater sleep disturbance.
|
Baseline, week 52
|
|
Change from baseline in Impact of Weight on Quality of Life-Lite Clinical Trials (IWQOL-Lite-CT) Physical Function Composite Score
Tidsram: Baseline, week 52
|
Baseline, week 52
|
|
|
Percentage of participants with apnea-hypopnea events less then 15
Tidsram: Baseline, week 52
|
Baseline, week 52
|
|
|
Change From Baseline in Epworth Sleepiness Scale Total Score
Tidsram: Baseline, week 52
|
Baseline, week 52
|
|
|
Change from baseline in IWQoL-Lite-CT physical function composite score
Tidsram: Baseline, week 52
|
Baseline, week 52
|
|
|
Change From Baseline in IWQOL-Lite-CT Physical Composite Score
Tidsram: Baseline, week 52
|
Baseline, week 52
|
|
|
Change from baseline in IWQoL-Lite-CT Psychosocial Composite Score
Tidsram: Baseline, week 52
|
Baseline, week 52
|
|
|
Change From Baseline in IWQoL-Lite-CT Total Score
Tidsram: Baseline, week 52
|
Baseline, week 52
|
|
|
Change From Baseline in Body Weight
Tidsram: Baseline, week 52
|
Baseline, week 52
|
|
|
Change From Baseline in Body Mass Index (BMI)
Tidsram: Baseline, week 52
|
Baseline, week 52
|
|
|
Change From Baseline in Waist Circumference
Tidsram: Baseline, week 52
|
Baseline, week 52
|
|
|
Change From Baseline in Neck Circumference
Tidsram: Baseline, wee 52
|
Baseline, wee 52
|
|
|
Change From Baseline in Short Form 36-Item ((SF-36)
Tidsram: Baseline, week 52
|
Baseline, week 52
|
|
|
Percentage of Participants With Improvement in Patient Global Impression of Severity (PGI-S) Sleepiness Category
Tidsram: Week 52
|
Week 52
|
|
|
Percentage of Participants With Improvement in Patient Global Impression of Severity (PGI-S) Fatigue Category
Tidsram: Week 52
|
Week 52
|
|
|
Percentage of Participants With Improvement in Patient Global Impression of Severity (PGI-S) Snoring Category
Tidsram: Baseline, wee 52
|
Baseline, wee 52
|
|
|
Percentage of Participants Reporting Improvement in Patient Global Impression of Change (PGI-C) Sleepiness
Tidsram: Week 52
|
Week 52
|
|
|
Percentage of Participants Reporting Improvement in Patient Global Impression of Change (PGI-C) Fatigue
Tidsram: Week 52
|
Week 52
|
|
|
Percentage of Participants Reporting Improvement in Patient Global Impression of Change (PGI-C) Sleep Quality
Tidsram: Week 52
|
Week 52
|
|
|
Percentage of Participants Reporting Improvement in Patient Global Impression of Change (PGI-C) Snoring
Tidsram: Week 52
|
Week 52
|
|
|
Change From Baseline in EuroQol 5-Dimension, 5-Level (EQ-5D-5L) Index Score
Tidsram: Baseline, week 52
|
Baseline, week 52
|
|
|
Change From Baseline in EuroQol-visual analog scale (EQ-VAS) Score
Tidsram: Baseline, week 52
|
Baseline, week 52
|
|
|
Change From Baseline in Work Productivity and Activity Impairment - General Health (WPAI:GH) Absenteeism Score
Tidsram: Baseline, week 52
|
Baseline, week 52
|
|
|
Change From Baseline in WPAI:GH Presenteeism Score
Tidsram: Baseline, week 52
|
Baseline, week 52
|
|
|
Change From Baseline in WPAI:GH Work Productivity Loss Score
Tidsram: Baseline, week 52
|
Baseline, week 52
|
|
|
Change From Baseline in WPAI:GH Activity Impairment Score
Tidsram: Baseline, week 52
|
Baseline, week 52
|
|
|
Number of participants with Treatment-Emergent Adverse Event (TEAE)
Tidsram: Week 52
|
Week 52
|
|
|
Number of participants with Serious Adverse Event (SAE)
Tidsram: Week 52
|
Week 52
|
|
|
Number of participants with Adverse event (AE) leading to permanent discontinuation from study intervention or study
Tidsram: Week 52
|
Week 52
|
|
|
Number of participants with Adverse Events of Special Interest (AESI)
Tidsram: Week 52
|
Week 52
|
|
|
Number of participants with clinical laboratory abnormalities
Tidsram: Week 52
|
Week 52
|
|
|
Change From Baseline in Diastolic Blood Pressure
Tidsram: Baseline, week 52
|
Baseline, week 52
|
|
|
Change From Baseline in Total Cholesterol
Tidsram: Baseline, week 52
|
Baseline, week 52
|
|
|
Change From Baseline in High-density lipoprotein cholesterol (HDL-C)
Tidsram: Baseline, week 52
|
Baseline, week 52
|
|
|
Change From Baseline in Low-density lipoprotein cholesterol (LDL-C)
Tidsram: Baseline, week 52
|
Baseline, week 52
|
|
|
Change From Baseline in Non-HDL Cholesterol
Tidsram: Baseline, week 52
|
Baseline, week 52
|
|
|
Change From Baseline in Very low-density lipoprotein cholesterol (VLDL) Cholesterol
Tidsram: Baseline, week 52
|
Baseline, week 52
|
|
|
Change From Baseline in Triglycerides
Tidsram: Baseline, week 52
|
Baseline, week 52
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Studierektor: Pfizer CT.gov Call Center, Pfizer
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Användbara länkar
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
19 september 2026
Primärt slutförande (Beräknad)
19 juni 2028
Avslutad studie (Beräknad)
19 juni 2028
Studieregistreringsdatum
Först inskickad
11 september 2026
Först inskickad som uppfyllde QC-kriterierna
11 september 2026
Första postat (Faktisk)
16 september 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
16 september 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
11 september 2026
Senast verifierad
1 september 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Neurologiska manifestationer
- Sjukdomar i nervsystemet
- Mentala störningar
- Näringsstörningar
- Övernäring
- Kroppsvikt
- Luftvägssjukdomar
- Andningsstörningar
- Tecken och symtom, andningsvägar
- Sömnstörningar, inneboende
- Dyssomni
- Patologiska tillstånd, tecken och symtom
- Närings- och metabola sjukdomar
- Tecken och symtom
- Övervikt
- Fetma
- Sömnapnésyndrom
- Apné
- Vakna sömnstörningar
Andra studie-ID-nummer
- C6491020
- VESPER-OSA 1 (Annan identifierare: Alias Study Number)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
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.
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Ja
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .