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 Use a Breathing Machine (PAP) (VESPER-OSA 1)
ClinicalTrials.gov ID: NCT07823608
What this study is testing
What is Berobenatide?
This is an investigational injectable medicine being studied to see if it can help adults with obstructive sleep apnea and overweight or obesity who use a breathing machine.
Also referred to as MET-097i, PF-08653944.
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 aims to learn if the medicine berobenatide is safe and if it helps improve sleep apnea and body weight.
- Who it's for
- The study is looking for adults with moderate to severe sleep apnea and overweight or obesity who already use a breathing machine.
- What's involved
- Participants will get a monthly injection under the skin, either the study medicine or a fake shot. They will also have sleep tests, health checks, and fill out questionnaires.
- Time commitment
- Participants will attend regular study visits and may give some injections at home after training.
- 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)
- Ongoing positive airway pressure (PAP) therapy for obstructive sleep apnea that is expected to continue during the study.
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
- Little Rock, Arkansas, United States
- Riverside, California, United States
- Bradenton, Florida, United States
- Maplewood, Minnesota, United States
- Dallas, Texas, 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; Little Rock, Arkansas, United States; Riverside, California, United States; Bradenton, Florida, United States; Maplewood, Minnesota, United States; Dallas, Texas, 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.