Recruiting
Phase 3

Berobenatide

Sponsor:

Pfizer

Code:

NCT07823608

Conditions

Apnea

Sleep Disorders

Overweight and/or Obesity

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Berobenatide

Placebo

Study Details

Brief summary:

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 use 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 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.

Conditions

Apnea

Sleep Disorders

Overweight and/or Obesity

Study ID

NCT07823608

Start date

Sep 17, 2026

Status verified date

Sep, 2026

Completion date

Jun 18, 2028

Anticipated

Primary completion date

Apr 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

258 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment Arm

Participants will receive berobenatide by Subcutaneous Injection.

placebo comparator: Placebo

Participants will receive matching placebo by Subcutaneous Injection.

Interventions

Berobenatide

By Subcutaneous Injection

Placebo

By Subcutaneous Injection

Primary outcome measure

  • Change From Baseline in Apnea-Hypopnea Index (AHI) [ Time Frame: baseline, Week 52 ]

Central Contacts and Locations

Central contacts

Locations

Headlands Research - Twin Cities

Recruiting

Maplewood, Minnesota, United States, 55109

More Information

Sponsor

Pfizer

Last update posted

Sep 29, 2026

Last verified

Sep, 2026

Keywords

  • Sleep Apnea
  • Obesity
  • Overweight
  • Sleep Disorders
  • Vesper

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-30. This information was provided to ClinicalTrials.gov by Pfizer on 2026-09-29. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.