Berobenatide in adults with sleep apnea and obesity using a PAP machine

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 3 interventional trial evaluating the safety and effects of berobenatide given as a monthly subcutaneous injection. Adults with moderate to severe obstructive sleep apnea and BMI ≥27 kg/m² who are using PAP therapy are eligible and will be randomly assigned to berobenatide or placebo. The study includes in-clinic visits, sleep studies, and questionnaires to assess outcomes, with some doses potentially administered at home after training. The trial is sponsored by Pfizer and conducted at several sites in the United States.

Why it matters

Who can join: the full rules

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).

Where it's running

• Cullman Clinical Trials
  Cullman, Alabama, United States Recruiting
• Preferred Research Partners, Inc.
  Little Rock, Arkansas, United States Recruiting
• Probe Clinical Research Corporation
  Riverside, California, United States Recruiting
• DM Clinical Research
  Bradenton, Florida, United States Recruiting
• Headlands Research - Twin Cities
  Maplewood, Minnesota, United States Recruiting
• Velocity Clinical Research, Dallas
  Dallas, Texas, United States Recruiting

Study contacts

• Study coordinator: Pfizer CT.gov Call Center
• Email: ClinicalTrials.gov_Inquiries@pfizer.com
• Phone: 1-800-718-1021

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Berobenatide in adults with sleep apnea and obesity who don’t use a PAP machine

  This study tests berobenatide versus placebo in adults with moderate-to-severe obstructive sleep apnea and overweight or obesity who are not using PAP therapy.

  Recruiting at 3 sites Phase 3 Pfizer · Cullman, Alabama and 3 other locations · NCT07881757

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• Switching to a monthly dose of Berobenatide to help keep weight off after weight loss with semaglutide or tirzepatide

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• Body- or Mind-based regulation in women with overweight or obesity

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.