A Phase 3 interventional study of Berobenatide and Placebo in Apnea, Sleep Disorders and Overweight and/or Obesity, sponsored by Pfizer. Recruiting at 8 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Pfizer · Phase 3, Interventional, and Treatment
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.
1,084 studies on the registry are indexed under Sleep Apnea Syndromes; 171 are open to participants now.
This study's planned enrollment of 258 is above the median of 60 across 673 interventional studies indexed under Sleep Apnea Syndromes.
Browse Sleep Apnea Syndromes studies →Pfizer is the lead sponsor of 3,334 studies on the registry; 149 are open to participants now.
Of its 601 completed or terminated interventional studies of FDA-regulated products, 391 (65%) have results posted.
Compared within Sleep Apnea Syndromes, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Apnea. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive berobenatide by Subcutaneous Injection.
Drug: Berobenatide
Participants will receive matching placebo by Subcutaneous Injection.
Other: Placebo
By Subcutaneous Injection
Also known as: MET-097i, PF-08653944
By Subcutaneous Injection
Change From Baseline in Apnea-Hypopnea Index (AHI)
Time frame: baseline, Week 52
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
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..
Time frame: 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.
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
Change From Baseline in Total Cholesterol
Time frame: Baseline, week 52
Change From Baseline in High-density lipoprotein cholesterol (HDL-C)
Time frame: Baseline, week 52
Change From Baseline in Low-density lipoprotein cholesterol (LDL-C)
Time frame: Baseline, week 52
Change From Baseline in Non-HDL Cholesterol
Time frame: Baseline, week 52
Change From Baseline in Very low-density lipoprotein cholesterol (VLDL) Cholesterol
Time frame: Baseline, week 52
Change From Baseline in Triglycerides
Time frame: Baseline, week 52
Plan to share: 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.
Data sharing details ↗ · www.pfizer.com
Started Sep 2026 (actual). Primary completion is estimated for Apr 2028, 19 months after the start.
Primary completion moved once since we started tracking on Sep 25, 2026: Jun 2028 → Apr 2028, on Sep 29, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Berobenatide