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NCT Number: NCT07823608

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)

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.

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Key information

Conditions

Apnea Body Weight Dyssomnias Mental Disorders Nervous System Diseases Neurologic Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Overweight and/or Obesity Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Sleep Apnea Syndromes Sleep Disorders Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Berobenatide

Drug

By Subcutaneous Injection

Other names: MET-097i, PF-08653944

Placebo

Other

By Subcutaneous Injection

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

  5. Change From Baseline in Sleep Apnea Specific Hypoxic Burden (SASHB)

    Time frame: Baseline, week 52

  6. Percentage of participants who achieve either AHI <5 events/hour or AHI 5-14 events/hour with Epworth Sleepiness Scale (ESS) score ≤10

    Time frame: baseline, week 52

  7. Change From Baseline in Systolic Blood Pressure (SBP)

    Time frame: Baseline, week 52

  8. Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep-Related Impairment 8a T-score

    Time frame: 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..

  9. Change From Baseline in PROMIS Sleep Disturbance 8b T-score

    Time frame: Baseline, week 52

    Change from baseline in the PROMIS Sleep Disturbance Short Form 8b T-score. Higher scores indicate greater sleep disturbance.

  10. Change from baseline in Impact of Weight on Quality of Life-Lite Clinical Trials (IWQOL-Lite-CT) Physical Function Composite Score

    Time frame: Baseline, week 52

  11. Percentage of participants with apnea-hypopnea events less then 15

    Time frame: Baseline, week 52

  12. Change From Baseline in Epworth Sleepiness Scale Total Score

    Time frame: Baseline, week 52

  13. Change from baseline in IWQoL-Lite-CT physical function composite score

    Time frame: Baseline, week 52

  14. Change From Baseline in IWQOL-Lite-CT Physical Composite Score

    Time frame: Baseline, week 52

  15. Change from baseline in IWQoL-Lite-CT Psychosocial Composite Score

    Time frame: Baseline, week 52

  16. Change From Baseline in IWQoL-Lite-CT Total Score

    Time frame: Baseline, week 52

  17. Change From Baseline in Body Weight

    Time frame: Baseline, week 52

  18. Change From Baseline in Body Mass Index (BMI)

    Time frame: Baseline, week 52

  19. Change From Baseline in Waist Circumference

    Time frame: Baseline, week 52

  20. Change From Baseline in Neck Circumference

    Time frame: Baseline, wee 52

  21. Change From Baseline in Short Form 36-Item ((SF-36)

    Time frame: Baseline, week 52

  22. Percentage of Participants With Improvement in Patient Global Impression of Severity (PGI-S) Sleepiness Category

    Time frame: Week 52

  23. Percentage of Participants With Improvement in Patient Global Impression of Severity (PGI-S) Fatigue Category

    Time frame: Week 52

  24. Percentage of Participants With Improvement in Patient Global Impression of Severity (PGI-S) Snoring Category

    Time frame: Baseline, wee 52

  25. Percentage of Participants Reporting Improvement in Patient Global Impression of Change (PGI-C) Sleepiness

    Time frame: Week 52

  26. Percentage of Participants Reporting Improvement in Patient Global Impression of Change (PGI-C) Fatigue

    Time frame: Week 52

  27. Percentage of Participants Reporting Improvement in Patient Global Impression of Change (PGI-C) Sleep Quality

    Time frame: Week 52

  28. Percentage of Participants Reporting Improvement in Patient Global Impression of Change (PGI-C) Snoring

    Time frame: Week 52

  29. Change From Baseline in EuroQol 5-Dimension, 5-Level (EQ-5D-5L) Index Score

    Time frame: Baseline, week 52

  30. Change From Baseline in EuroQol-visual analog scale (EQ-VAS) Score

    Time frame: Baseline, week 52

  31. Change From Baseline in Work Productivity and Activity Impairment - General Health (WPAI:GH) Absenteeism Score

    Time frame: Baseline, week 52

  32. Change From Baseline in WPAI:GH Presenteeism Score

    Time frame: Baseline, week 52

  33. Change From Baseline in WPAI:GH Work Productivity Loss Score

    Time frame: Baseline, week 52

  34. Change From Baseline in WPAI:GH Activity Impairment Score

    Time frame: Baseline, week 52

  35. Number of participants with Treatment-Emergent Adverse Event (TEAE)

    Time frame: Week 52

  36. Number of participants with Serious Adverse Event (SAE)

    Time frame: Week 52

  37. Number of participants with Adverse event (AE) leading to permanent discontinuation from study intervention or study

    Time frame: Week 52

  38. Number of participants with Adverse Events of Special Interest (AESI)

    Time frame: Week 52

  39. Number of participants with clinical laboratory abnormalities

    Time frame: Week 52

  40. Change From Baseline in Diastolic Blood Pressure

    Time frame: Baseline, week 52

  41. Change From Baseline in Total Cholesterol

    Time frame: Baseline, week 52

  42. Change From Baseline in High-density lipoprotein cholesterol (HDL-C)

    Time frame: Baseline, week 52

  43. Change From Baseline in Low-density lipoprotein cholesterol (LDL-C)

    Time frame: Baseline, week 52

  44. Change From Baseline in Non-HDL Cholesterol

    Time frame: Baseline, week 52

  45. Change From Baseline in Very low-density lipoprotein cholesterol (VLDL) Cholesterol

    Time frame: Baseline, week 52

  46. Change From Baseline in Triglycerides

    Time frame: Baseline, week 52

Study contacts

Contact information is provided by the study sponsor or research team.

Pfizer CT.gov Call Center

CONTACT

[email protected]

1-800-718-1021

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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)

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Sep 16, 2026
Registry last updated
Sep 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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