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Not yet recruitingPhase 3

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)

A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF ONCE-MONTHLY BEROBENATIDE IN ADULTS WITH OBSTRUCTIVE SLEEP APNEA AND OVERWEIGHT OR OBESITY NOT RECEIVING POSITIVE AIRWAY PRESSURE THERAPY (VESPER-OSA 2)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Injections, Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The study treatment will be given as an injection under the skin approximately once a month."
  • "During the study, participants will attend study visits, undergo sleep studies, complete questionnaires, and have health assessments performed."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the safety and effects of berobenatide, a shot given about once a month, compared with a placebo (a shot with no active medicine). It is for adults with overweight or obesity and moderate to severe obstructive sleep apnea, which causes breathing to stop and start during sleep, who do not use a PAP breathing machine. Researchers will check effects on sleep apnea, weight, and other health measures.

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 are not using 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 unable or unwilling 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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 or older.
  • Have a body mass index (BMI), a measure based on height and weight, of 27 or higher at screening.
  • Have a past diagnosis of moderate to severe obstructive sleep apnea.
  • Are unable or unwilling to use a PAP breathing machine and have not used one for at least 4 weeks before screening.

Who can't join

  • Report a weight change of more than 5% in the 90 days before screening.
  • Have any type of diabetes. Diabetes during pregnancy that has gone away is allowed.
  • Have ever had pancreatitis, which is swelling and irritation of the pancreas.
  • You or a family member has had medullary thyroid carcinoma (a type of thyroid cancer) or MEN 2 (a condition that causes tumors in glands).
  • Have other sleep-related breathing problems, or major differences in the shape of the face or skull, that could affect the study tests or results.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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).

Study sites (2)

FL

TX