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)

NCT07823608 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: C6491020VESPER-OSA 1
• Study Type: interventional
• Target: 258
• Locations: 1 country
• Sites: 3

Brief 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 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

Sleep Disorders; Overweight and/or Obesity; Apnea

Keywords

Sleep Apnea; Obesity; Overweight; Sleep Disorders; Vesper

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Apnea-Hypopnea Index (AHI)

  baseline, Week 52

Secondary Outcomes (46)

• Percent Change From Baseline in Body Weight

  Baseline, Week 52

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

  Baseline , week 52

• Percent change from baseline in AHI

  Baseline, week 52

• Percentage of participants with ≥ 50% AHI reduction

  baseline ,week 52

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

  Baseline, week 52

Study Arms (2)

Treatment Arm

EXPERIMENTAL

Participants will receive berobenatide by Subcutaneous Injection.

Drug: Berobenatide

Placebo

PLACEBO COMPARATOR

Participants will receive matching placebo by Subcutaneous Injection.

Other: Placebo

Interventions

Berobenatide DRUG

By Subcutaneous Injection

Also known as: MET-097i, PF-08653944

Treatment Arm

Placebo OTHER

By Subcutaneous Injection

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Pfizer: lead

Study Sites (3)

Cullman Clinical Trials

Cullman, Alabama, 35055, United States

NOT YET RECRUITING

DM Clinical Research

Bradenton, Florida, 34209, United States

NOT YET RECRUITING

Headlands Research - Twin Cities

Maplewood, Minnesota, 55109, United States

RECRUITING

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Apnea; Sleep Wake Disorders; Sleep Apnea Syndromes; Obesity; Overweight

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Nervous System Diseases; Neurologic Manifestations; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Central Study Contacts

Pfizer CT.gov Call Center

CONTACT

1-800-718-1021; ClinicalTrials.gov_Inquiries@pfizer.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2026
• First Posted: September 16, 2026
• Study Start: September 17, 2026
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): June 18, 2028
• Last Updated: September 29, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share

Locations

US (3)