ApneaPhase 3VESPER-OSA 2NCT07881757
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)
A Phase 3 study testing Berobenatide in people with Apnea and Sleep Disorders, run by Pfizer at 2 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Apnea, Sleep Disorders, Overweight and/or Obesity
- What is being tested?
- Berobenatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 258 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 Oct 2026to 20 Jul 2028
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
DM Clinical Research-Bradenton
Bradenton, Florida, 34209
DM Clinical Research-Tomball
Tomball, Texas, 77375
About this study
Official 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 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.
- Conditions
- Apnea, Sleep Disorders, Overweight and/or Obesity
- Being tested
- Berobenatide, Placebo
- Keywords
- Obstructive Sleep Apnea, OSA, Sleep Apnea, Breathing Disorder, Snoring, Daytime Sleepiness, Excessive Daytime Sleepiness, Breathing Stops During Sleep, Sleep Problems, Sleep Disorder, Sleep Study, Polysomnography, PSG
- Medical subject headings
- Apnea, Sleep Wake Disorders, Sleep Apnea, Obstructive, Sleep Apnea Syndromes, Dyspnea, Snoring, Disorders of Excessive Somnolence, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BerobenatideDrug
Also called PF-08653944, MET097
Subcutaneous injection
PlaceboDrug
Volume-matched subcutaneous placebo.
| Study group | Role | What they receive |
|---|---|---|
| Berobenatide | Experimental | Participants receive berobenatide by subcutaneous injection. Receives: Drug: Berobenatide |
| Placebo | Placebo comparator | Participants receive volume-matched placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Apnea-Hypopnea Index
Apnea-Hypopnea Index is the number of apnea and hypopnea events per hour of sleep, assessed by polysomnography.
Measured: Baseline, Week 52
Secondary outcomes (46)
Percent Change From Baseline in Body Weight
Measured: Baseline, Week 52
Change From Baseline in High-Sensitivity C-Reactive Protein
Measured: Baseline, Week 52
Percent Change From Baseline in Apnea-Hypopnea Index
Measured: Baseline, Week 52
Percentage of Participants With at Least 50% Reduction in Apnea-Hypopnea Index
Measured: Week 52
Change From Baseline in Sleep-Apnea-Specific Hypoxic Burden (SASHB)
Measured: Baseline, Week 52
Percentage of Participants With Obstructive Sleep Apnea Remission or Mild Non-Symptomatic Obstructive Sleep Apnea
Measured: Week 52
Change From Baseline in Systolic Blood Pressure
Measured: Baseline, Week 52
Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep-Related Impairment 8a T-Score
Measured: Baseline, Week 52
Change From Baseline in PROMIS Sleep Disturbance 8b T-Score
Measured: Baseline, Week 52
Percentage of Participants with AHI <5
Measured: Week 52
Percentage of Participants with AHI 5-14 with ESS (Epworth Sleepiness Scale) ≤10
Measured: Week 52
Percentage of participants with AHI less then 15
Measured: Week 52
Change From Baseline in Epworth Sleepiness Scale Total Score
Measured: Baseline, Week 52
Change From Baseline in Impact of Weight on Quality of Life-Lite Clinical Trials (IWQOL-Lite-CT) Physical Function Composite Score
Measured: Baseline, Week 52
Change From Baseline in IWQOL-Lite-CT Physical Composite Score
Measured: Baseline, Week 52
Change From Baseline in IWQOL-Lite-CT Psychosocial Composite Score
Measured: Baseline, Week 52
Change From Baseline in IWQOL-Lite-CT Total Score
Score ranges from 0 to 100; higher scores indicate better quality of life.
Measured: Baseline, Week 52
Change From Baseline in Body Weight
Measured: Baseline, Week 52
Change From Baseline in Body Mass Index
Measured: Baseline, Week 52
Change From Baseline in Waist Circumference
Measured: Baseline, Week 52
Change From Baseline in Neck Circumference
Measured: Baseline, Week 52
Change From Baseline in Short Form 36-Item (SF-36)
Measured: Baseline, Week 52
Percentage of Participants With Improvement in Patient Global Impression of Severity (PGI-S) Sleepiness Category
Measured: Week 52
Percentage of Participants With Improvement in Patient Global Impression of Severity (PGI-S) Fatigue Category
Measured: Week 52
Percentage of Participants With Improvement in Patient Global Impression of Severity (PGI-S) Snoring Category
Measured: Week 52
Percentage of Participants Reporting Improvement in Patient Global Impression of Change (PGI-C) Sleepiness
Measured: Week 52
Percentage of Participants Reporting Improvement in Patient Global Impression of Change (PGI-C) Fatigue
Measured: Week 52
Percentage of Participants Reporting Improvement in Patient Global Impression of Change (PGI-C) Sleep Quality
Measured: Week 52
Percentage of Participants Reporting Improvement in Patient Global Impression of Change (PGI-C) Snoring
Measured: Week 52
Change From Baseline in EuroQol 5-Dimension, 5-Level (EQ-5D-5L) Index Score
Measured: Baseline, Week 52
Change From Baseline in EuroQol-visual analog scale (EQ-VAS) Score
Measured: Baseline, Week 52
Change From Baseline in WPAI:GH Presenteeism Score
Measured: Baseline, Week 52
Change From Baseline in WPAI:GH Work Productivity Loss Score
Measured: Baseline, Week 52
Change From Baseline in WPAI:GH Activity Impairment Score
Measured: Baseline, Week 52
Number of participants with Treatment-Emergent Adverse Event (TEAE)
Measured: Week 52
Number of participants with Serious Adverse Event (SAE)
Measured: Week 52
Number of participants with Adverse event (AE) leading to permanent discontinuation from study intervention or study
Measured: Week 52
Number of participants with Adverse Events of Special Interest (AESI)
Measured: Week 52
Number of participants with clinical laboratory abnormalities
Measured: Week 52
Change From Baseline in Diastolic Blood Pressure
Measured: Baseline, Week 52
Change From Baseline in Total Cholesterol
Measured: Baseline, Week 52
Change From Baseline in High-density lipoprotein cholesterol (HDL-C)
Measured: Baseline, Week 52
Change From Baseline in Low-density lipoprotein cholesterol (LDL-C)
Measured: Baseline, week 52
Change From Baseline in Non-HDL Cholesterol
Measured: Baseline, Week 52
Change From Baseline in Very low-density lipoprotein cholesterol (VLDL) Cholesterol
Measured: Baseline, Week 52
Change From Baseline in Triglycerides
Measured: Baseline, Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study start19 Oct 2026 (estimated)
- Primary completion1 Jun 2028 (estimated)
- Study completion20 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ApneaStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 258 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07881757
- Sponsor's protocol ID
- C6491021
- Other IDs
- VESPER-OSA 2
- Acronym
- VESPER-OSA 2
- Status last verified
- Oct 2026
- First submitted
- 9 Oct 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.