Berobenatide in adults with sleep apnea and obesity who don’t use 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 Phase 3 trial evaluates the safety and effects of monthly berobenatide injections in adults with obstructive sleep apnea and overweight or obesity who have not used a PAP device for at least four weeks. Participants are randomly assigned to receive either berobenatide or a placebo and will attend scheduled study visits, with some doses potentially self-administered at home after training. The study uses standard clinical trial procedures to monitor sleep, symptoms, and adverse events. Enrollment targets adults 18 and older with BMI ≥27 kg/m² and a prior OSA diagnosis. Exclusion criteria include recent significant weight change, diabetes (with some exceptions), pancreatitis history, and certain thyroid cancer syndromes to minimize risk and confounding results.

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)
* Unable or unwilling to use positive airway pressure (PAP) therapy, and no use of PAP therapy for at least 4 weeks prior to screening

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
• DM Clinical Research-Bradenton
  Bradenton, Florida, United States Recruiting
• Headlands Research - Twin Cities
  Maplewood, Minnesota, United States Recruiting
• DM Clinical Research-Tomball
  Tomball, Texas, United States Not yet recruiting

Study contacts

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

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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.