Apnea study: Berobenatide
Official title A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
ClinicalTrials.gov ID: NCT07881757
What this study is testing
What is Berobenatide?
An investigational once‑monthly subcutaneous injectable medicine being studied as a potential treatment for obstructive sleep apnea in adults with overweight or obesity.
Also referred to as PF-08653944, MET097.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether berobenatide can improve sleep apnea and weight in adults who are overweight or obese and do not use a breathing machine.
- Who it's for
- You may be able to join if you are an adult with moderate to severe sleep apnea, are overweight or obese, and have not used or want to avoid a breathing machine.
- What's involved
- You will receive a monthly injection of either berobenatide or a pretend treatment. You will visit the study site for injections and training, and you may give some injections at home. You will also have sleep studies, questionnaires, and health checks during the study.
- Time commitment
- The study lasts about 12 months, with monthly visits for injections and regular check‑ins for sleep studies and health assessments.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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)
- Unable or unwilling to use positive airway pressure (PAP) therapy, and no use of PAP therapy for at least 4 weeks prior to screening
You likely can't join 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...
The study team makes the final eligibility decision.
Where it is enrolling
- Cullman, Alabama, United States
- Bradenton, Florida, United States
- Maplewood, Minnesota, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Cullman, Alabama, United States; Bradenton, Florida, United States; Maplewood, Minnesota, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.