ApneaPhase 3NCT07823608
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 study testing Berobenatide in people with Apnea and Sleep Disorders, run by Pfizer at 6 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 use a breathing machine (positive airway… 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
- 6 sitesUnited States
- Study dates
- 17 Sep 2026to 18 Jun 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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)
- Ongoing positive airway pressure (PAP) therapy for obstructive sleep apnea that is expected to continue during the study.
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
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
DM Clinical Research
Bradenton, Florida, 34209
- Not yet recruiting
Cullman Clinical Trials
Cullman, Alabama, 35055
- Not yet recruiting
Velocity Clinical Research, Dallas
Dallas, Texas, 75230
- Recruiting
Headlands Research - Twin Cities
Maplewood, Minnesota, 55109
- Recruiting
Probe Clinical Research Corporation
Riverside, California, 92501
- Not yet recruiting
DM Clinical Research
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 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.
- Conditions
- Apnea, Sleep Disorders, Overweight and/or Obesity
- Being tested
- Berobenatide, Placebo
- Keywords
- Sleep Apnea, Obesity, Overweight, Sleep Disorders, Vesper
- Medical subject headings
- Apnea, Sleep Wake Disorders, Sleep Apnea Syndromes, Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BerobenatideDrug
Also called MET-097i, PF-08653944
By Subcutaneous Injection
PlaceboOther
By Subcutaneous Injection
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Participants will receive berobenatide by Subcutaneous Injection. Receives: Drug: Berobenatide |
| Placebo | Placebo comparator | Participants will receive matching placebo by Subcutaneous Injection. Receives: Other: 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 (AHI)
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 (hs-CRP)
Measured: Baseline , week 52
Percent change from baseline in AHI
Measured: Baseline, week 52
Percentage of participants with ≥ 50% AHI reduction
Measured: baseline ,week 52
Change From Baseline in Sleep Apnea Specific Hypoxic Burden (SASHB)
Measured: 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
Measured: baseline, week 52
Change From Baseline in Systolic Blood Pressure (SBP)
Measured: Baseline, week 52
Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep-Related Impairment 8a T-score
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..
Measured: baseline, week 52
Change From Baseline in PROMIS Sleep Disturbance 8b T-score
Change from baseline in the PROMIS Sleep Disturbance Short Form 8b T-score. Higher scores indicate greater sleep disturbance.
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
Percentage of participants with apnea-hypopnea events less then 15
Measured: Baseline, week 52
Change From Baseline in Epworth Sleepiness Scale Total Score
Measured: Baseline, week 52
Change from baseline in 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
Measured: Baseline, week 52
Change From Baseline in Body Weight
Measured: Baseline, week 52
Change From Baseline in Body Mass Index (BMI)
Measured: Baseline, week 52
Change From Baseline in Waist Circumference
Measured: Baseline, week 52
Change From Baseline in Neck Circumference
Measured: Baseline, wee 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: Baseline, wee 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 Work Productivity and Activity Impairment - General Health (WPAI:GH) Absenteeism 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 posted16 Sep 2026
- Study start17 Sep 2026
- Primary completion30 Apr 2028 (estimated)
- Study completion18 Jun 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
- NCT07823608
- Sponsor's protocol ID
- C6491020
- Other IDs
- VESPER-OSA 1
- Status last verified
- Oct 2026
- First submitted
- 11 Sep 2026
- Last updated
- 13 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 RECEIVING POSITIVE AIRWAY PRESSURE THERAPY (VESPER-OSA 1)
- ClinicalTrials.gov ID
- NCT07823608
- Acronym / sponsor ID
- C6491020
- Conditions
- Apnea, Sleep Disorders, Overweight and/or Obesity
- Keywords
- Sleep Apnea, Obesity, Overweight, Sleep Disorders, Vesper
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 258 participants (estimated)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 17 Sep 2026 (actual)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 18 Jun 2028 (estimated)
- First posted
- 16 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Drug: BerobenatideParticipants will receive berobenatide by Subcutaneous Injection. |
| Placebo | Placebo comparator | Other: PlaceboParticipants will receive matching placebo by Subcutaneous Injection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BerobenatideAlso: MET-097i, PF-08653944By Subcutaneous Injection | Drug | Treatment Arm |
| PlaceboBy Subcutaneous Injection | Other | Placebo |
Primary outcome
Change From Baseline in Apnea-Hypopnea Index (AHI)
Time frame: baseline, Week 52
46 secondary outcomes
Percent Change From Baseline in Body Weight
Time frame: Baseline, Week 52
Change From Baseline in High-Sensitivity C-Reactive Protein (hs-CRP)
Time frame: Baseline , week 52
Percent change from baseline in AHI
Time frame: Baseline, week 52
Percentage of participants with ≥ 50% AHI reduction
Time frame: baseline ,week 52
Change From Baseline in Sleep Apnea Specific Hypoxic Burden (SASHB)
Time frame: 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
Change From Baseline in Systolic Blood Pressure (SBP)
Time frame: 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 PROMIS Sleep Disturbance 8b T-score
Time frame: 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
Percentage of participants with apnea-hypopnea events less then 15
Time frame: Baseline, week 52
Change From Baseline in Epworth Sleepiness Scale Total Score
Time frame: Baseline, week 52
Change from baseline in IWQoL-Lite-CT physical function composite score
Time frame: Baseline, week 52
Change From Baseline in IWQOL-Lite-CT Physical Composite Score
Time frame: Baseline, week 52
Change from baseline in IWQoL-Lite-CT Psychosocial Composite Score
Time frame: Baseline, week 52
Change From Baseline in IWQoL-Lite-CT Total Score
Time frame: Baseline, week 52
Change From Baseline in Body Weight
Time frame: Baseline, week 52
Change From Baseline in Body Mass Index (BMI)
Time frame: Baseline, week 52
Change From Baseline in Waist Circumference
Time frame: Baseline, week 52
Change From Baseline in Neck Circumference
Time frame: Baseline, wee 52
Change From Baseline in Short Form 36-Item ((SF-36)
Time frame: Baseline, week 52
Percentage of Participants With Improvement in Patient Global Impression of Severity (PGI-S) Sleepiness Category
Time frame: Week 52
Percentage of Participants With Improvement in Patient Global Impression of Severity (PGI-S) Fatigue Category
Time frame: Week 52
Percentage of Participants With Improvement in Patient Global Impression of Severity (PGI-S) Snoring Category
Time frame: Baseline, wee 52
Percentage of Participants Reporting Improvement in Patient Global Impression of Change (PGI-C) Sleepiness
Time frame: Week 52
Percentage of Participants Reporting Improvement in Patient Global Impression of Change (PGI-C) Fatigue
Time frame: Week 52
Percentage of Participants Reporting Improvement in Patient Global Impression of Change (PGI-C) Sleep Quality
Time frame: Week 52
Percentage of Participants Reporting Improvement in Patient Global Impression of Change (PGI-C) Snoring
Time frame: Week 52
Change From Baseline in EuroQol 5-Dimension, 5-Level (EQ-5D-5L) Index Score
Time frame: Baseline, week 52
Change From Baseline in EuroQol-visual analog scale (EQ-VAS) Score
Time frame: Baseline, week 52
Change From Baseline in Work Productivity and Activity Impairment - General Health (WPAI:GH) Absenteeism Score
Time frame: Baseline, week 52
Change From Baseline in WPAI:GH Presenteeism Score
Time frame: Baseline, week 52
Change From Baseline in WPAI:GH Work Productivity Loss Score
Time frame: Baseline, week 52
Change From Baseline in WPAI:GH Activity Impairment Score
Time frame: Baseline, week 52
Number of participants with Treatment-Emergent Adverse Event (TEAE)
Time frame: Week 52
Number of participants with Serious Adverse Event (SAE)
Time frame: Week 52
Number of participants with Adverse event (AE) leading to permanent discontinuation from study intervention or study
Time frame: Week 52
Number of participants with Adverse Events of Special Interest (AESI)
Time frame: Week 52
Number of participants with clinical laboratory abnormalities
Time frame: Week 52
Change From Baseline in Diastolic Blood Pressure
Time frame: Baseline, week 52
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: 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.
Related trials for Apnea
Recruiting
The Effects of Successful OSA Treatment on Memory and AD Biomarkers in Older Adults Study
Obstructive Sleep Apnea, Cognitive Decline
RecruitingObservational study
Prevalence, Phenotypes, Predictors and Prognostic Implication of Obstructive Sleep Apnea in Pulmonary Hypertension
Sleep Apnea, Obstructive Sleep Apnea
Not yet recruiting
Strap To Reduce Apnea in Preterm Infants: A Randomized Crossover Trial
Apnea of Prematurity, Intermittent Hypoxemia
Not yet recruiting
Comparing Two Types of Breathing Support in People With COPD, High Carbon Dioxide Levels, and Sleep Apnea
OSA COPD Overlap Syndrome
Recruiting
Effect of Transcutaneous Electrical Stimulation on Polysomnographic Parameters in Patients With Obstructive Sleep Apnea
Obstructive Sleep Apnea
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pfizer CT.gov Call Center study director
Pfizer
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Berobenatide in people with Apnea and Sleep Disorders, run by Pfizer at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pfizer CT.gov Call Center (1-800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Apnea-Hypopnea Index (AHI) (time frame: baseline, Week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.