RecruitingPhase 3

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)

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)

Lead sponsor

Pfizer

Asset

MET097 / PF-08653944

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

Estimated enrollment

258

Study population

Apnea, Obesity / overweight, Sleep apnea, Sleep Disorders, Sleep Wake Disorders

Eligibility highlights

•BMI ≥27

Primary endpoint

•Apnea-Hypopnea Index (AHI)

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07823608

Org study IDC6491020

Secondary IDVESPER-OSA 1Alias Study Number

Timeline

Milestones

Study first posted2026-09-16actual

Study start2026-09-17actual

Last update posted2026-11-05actual

Primary completion2028-04-30estimated

Study completion2028-06-18estimated

Assets

Investigational agents

MET097 / PF-08653944

Who this study enrolls

ApneaObesity / overweightSleep apneaSleep DisordersSleep Wake Disorders

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

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).

Endpoints (47)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)

Patient-reported / QoL

Cardiometabolic biomarkers

Weight & body composition

Safety / tolerability / PK

Weight & body composition

5 endpoints

Secondary/protocol endpoint

Percent Change From Baseline in Body Weight

Time frame:Baseline, Week 52

percent change from baseline, improvement

Secondary/protocol endpoint

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

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Body Weight

Time frame:Baseline, week 52

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Body Mass Index (BMI)

Time frame:Baseline, week 52

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Waist Circumference

Time frame:Baseline, week 52

change from baseline, improvement

Cardiometabolic biomarkers

9 endpoints

Secondary/protocol endpoint

Change From Baseline in High-Sensitivity C-Reactive Protein (hs-CRP)

Time frame:Baseline , week 52

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Systolic Blood Pressure (SBP)

Time frame:Baseline, week 52

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Diastolic Blood Pressure

Time frame:Baseline, week 52

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Total Cholesterol

Time frame:Baseline, week 52

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Baseline, week 52

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Baseline, week 52

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Non-HDL Cholesterol

Time frame:Baseline, week 52

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Baseline, week 52

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Triglycerides

Time frame:Baseline, week 52

change from baseline, improvement

Patient-reported / QoL

10 endpoints

Secondary/protocol endpoint

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, improvement

Secondary/protocol endpoint

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

Time frame:Baseline, week 52

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Week 52

threshold achievement, improvement

Secondary/protocol endpoint

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

Time frame:Week 52

threshold achievement, improvement

Secondary/protocol endpoint

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

Time frame:Baseline, wee 52

threshold achievement, improvement

Secondary/protocol endpoint

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

Time frame:Week 52

threshold achievement, improvement

Secondary/protocol endpoint

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

Time frame:Week 52

threshold achievement, improvement

Secondary/protocol endpoint

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

Time frame:Week 52

threshold achievement, improvement

Secondary/protocol endpoint

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

Time frame:Week 52

threshold achievement, improvement

Secondary/protocol endpoint

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

Time frame:Baseline, week 52

change from baseline, improvement

Safety / tolerability / PK

5 endpoints

Secondary/protocol endpoint

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

Time frame:Week 52

event count, event

Secondary/protocol endpoint

Number of participants with Serious Adverse Event (SAE)

Time frame:Week 52

event count, event

Secondary/protocol endpoint

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

Time frame:Week 52

event count, event

Secondary/protocol endpoint

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

Time frame:Week 52

event count, event

Secondary/protocol endpoint

Number of participants with clinical laboratory abnormalities

Time frame:Week 52

event count, event

Other (unclassified)

18 endpoints

Primary/protocol endpoint/low confidence

Change From Baseline in Apnea-Hypopnea Index (AHI)

Time frame:baseline, Week 52

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Percent change from baseline in AHI

Time frame:Baseline, week 52

percent change from baseline, improvement

Secondary/protocol endpoint/low confidence

Percentage of participants with ≥ 50% AHI reduction

Time frame:baseline ,week 52

threshold achievement, improvement

Secondary/protocol endpoint/low confidence

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

Time frame:Baseline, week 52

change from baseline, improvement

Secondary/protocol endpoint/low confidence

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

threshold achievement, improvement

Secondary/protocol endpoint/low confidence

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

Time frame:Baseline, week 52

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Percentage of participants with apnea-hypopnea events less then 15

Time frame:Baseline, week 52

threshold achievement, improvement

Secondary/protocol endpoint/low confidence

Change From Baseline in Epworth Sleepiness Scale Total Score

Time frame:Baseline, week 52

change from baseline, improvement

Secondary/protocol endpoint/low confidence

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

Time frame:Baseline, week 52

change from baseline, improvement

Secondary/protocol endpoint/low confidence

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

Time frame:Baseline, week 52

change from baseline, improvement

Secondary/protocol endpoint/low confidence

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

Time frame:Baseline, week 52

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change From Baseline in IWQoL-Lite-CT Total Score

Time frame:Baseline, week 52

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change From Baseline in Neck Circumference

Time frame:Baseline, wee 52

change from baseline, improvement

Secondary/protocol endpoint/low confidence

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

Time frame:Baseline, week 52

change from baseline, improvement

Secondary/protocol endpoint/low confidence

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

Time frame:Baseline, week 52

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change From Baseline in WPAI:GH Presenteeism Score

Time frame:Baseline, week 52

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change From Baseline in WPAI:GH Work Productivity Loss Score

Time frame:Baseline, week 52

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change From Baseline in WPAI:GH Activity Impairment Score

Time frame:Baseline, week 52

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateNovember 5, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the November 5, 2026 snapshot.