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)

September 11, 2026 updated by: 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

258

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Participants will receive matching placebo by Subcutaneous Injection.
Other: Placebo
By Subcutaneous Injection
Experimental: Treatment Arm
Participants will receive berobenatide by Subcutaneous Injection.
Drug: Berobenatide
By Subcutaneous Injection
Other Names:
  • PF-08653944
  • MET-097i

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change From Baseline in Apnea-Hypopnea Index (AHI)
Time Frame: baseline, Week 52
baseline, Week 52

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline in Body Weight
Time Frame: Baseline, Week 52
Baseline, Week 52
Change From Baseline in High-Sensitivity C-Reactive Protein (hs-CRP)
Time Frame: Baseline , week 52
Baseline , week 52
Percent change from baseline in AHI
Time Frame: Baseline, week 52
Baseline, week 52
Percentage of participants with ≥ 50% AHI reduction
Time Frame: baseline ,week 52
baseline ,week 52
Change From Baseline in Sleep Apnea Specific Hypoxic Burden (SASHB)
Time Frame: 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
Time Frame: baseline, week 52
baseline, week 52
Change From Baseline in Systolic Blood Pressure (SBP)
Time Frame: Baseline, week 52
Baseline, week 52
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..
baseline, week 52
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.
Baseline, week 52
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
Baseline, week 52
Percentage of participants with apnea-hypopnea events less then 15
Time Frame: Baseline, week 52
Baseline, week 52
Change From Baseline in Epworth Sleepiness Scale Total Score
Time Frame: Baseline, week 52
Baseline, week 52
Change from baseline in IWQoL-Lite-CT physical function composite score
Time Frame: Baseline, week 52
Baseline, week 52
Change From Baseline in IWQOL-Lite-CT Physical Composite Score
Time Frame: Baseline, week 52
Baseline, week 52
Change from baseline in IWQoL-Lite-CT Psychosocial Composite Score
Time Frame: Baseline, week 52
Baseline, week 52
Change From Baseline in IWQoL-Lite-CT Total Score
Time Frame: Baseline, week 52
Baseline, week 52
Change From Baseline in Body Weight
Time Frame: Baseline, week 52
Baseline, week 52
Change From Baseline in Body Mass Index (BMI)
Time Frame: Baseline, week 52
Baseline, week 52
Change From Baseline in Waist Circumference
Time Frame: Baseline, week 52
Baseline, week 52
Change From Baseline in Neck Circumference
Time Frame: Baseline, wee 52
Baseline, wee 52
Change From Baseline in Short Form 36-Item ((SF-36)
Time Frame: Baseline, week 52
Baseline, week 52
Percentage of Participants With Improvement in Patient Global Impression of Severity (PGI-S) Sleepiness Category
Time Frame: Week 52
Week 52
Percentage of Participants With Improvement in Patient Global Impression of Severity (PGI-S) Fatigue Category
Time Frame: Week 52
Week 52
Percentage of Participants With Improvement in Patient Global Impression of Severity (PGI-S) Snoring Category
Time Frame: Baseline, wee 52
Baseline, wee 52
Percentage of Participants Reporting Improvement in Patient Global Impression of Change (PGI-C) Sleepiness
Time Frame: Week 52
Week 52
Percentage of Participants Reporting Improvement in Patient Global Impression of Change (PGI-C) Fatigue
Time Frame: Week 52
Week 52
Percentage of Participants Reporting Improvement in Patient Global Impression of Change (PGI-C) Sleep Quality
Time Frame: Week 52
Week 52
Percentage of Participants Reporting Improvement in Patient Global Impression of Change (PGI-C) Snoring
Time Frame: Week 52
Week 52
Change From Baseline in EuroQol 5-Dimension, 5-Level (EQ-5D-5L) Index Score
Time Frame: Baseline, week 52
Baseline, week 52
Change From Baseline in EuroQol-visual analog scale (EQ-VAS) Score
Time Frame: Baseline, week 52
Baseline, week 52
Change From Baseline in Work Productivity and Activity Impairment - General Health (WPAI:GH) Absenteeism Score
Time Frame: Baseline, week 52
Baseline, week 52
Change From Baseline in WPAI:GH Presenteeism Score
Time Frame: Baseline, week 52
Baseline, week 52
Change From Baseline in WPAI:GH Work Productivity Loss Score
Time Frame: Baseline, week 52
Baseline, week 52
Change From Baseline in WPAI:GH Activity Impairment Score
Time Frame: Baseline, week 52
Baseline, week 52
Number of participants with Treatment-Emergent Adverse Event (TEAE)
Time Frame: Week 52
Week 52
Number of participants with Serious Adverse Event (SAE)
Time Frame: Week 52
Week 52
Number of participants with Adverse event (AE) leading to permanent discontinuation from study intervention or study
Time Frame: Week 52
Week 52
Number of participants with Adverse Events of Special Interest (AESI)
Time Frame: Week 52
Week 52
Number of participants with clinical laboratory abnormalities
Time Frame: Week 52
Week 52
Change From Baseline in Diastolic Blood Pressure
Time Frame: Baseline, week 52
Baseline, week 52
Change From Baseline in Total Cholesterol
Time Frame: Baseline, week 52
Baseline, week 52
Change From Baseline in High-density lipoprotein cholesterol (HDL-C)
Time Frame: Baseline, week 52
Baseline, week 52
Change From Baseline in Low-density lipoprotein cholesterol (LDL-C)
Time Frame: Baseline, week 52
Baseline, week 52
Change From Baseline in Non-HDL Cholesterol
Time Frame: Baseline, week 52
Baseline, week 52
Change From Baseline in Very low-density lipoprotein cholesterol (VLDL) Cholesterol
Time Frame: Baseline, week 52
Baseline, week 52
Change From Baseline in Triglycerides
Time Frame: Baseline, week 52
Baseline, week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 19, 2026

Primary Completion (Estimated)

June 19, 2028

Study Completion (Estimated)

June 19, 2028

Study Registration Dates

First Submitted

September 11, 2026

First Submitted That Met QC Criteria

September 11, 2026

First Posted (Actual)

September 16, 2026

Study Record Updates

Last Update Posted (Actual)

September 16, 2026

Last Update Submitted That Met QC Criteria

September 11, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C6491020
  • VESPER-OSA 1 (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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