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) (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)
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.
연구 개요
연구 유형
등록 (추정된)
단계
- 3단계
연락처 및 위치
연구 연락처
- 이름: Pfizer CT.gov Call Center
- 전화번호: 1-800-718-1021
- 이메일: ClinicalTrials.gov_Inquiries@pfizer.com
연구 장소
-
-
Alabama
-
Cullman, Alabama, 미국, 35055
- 모병
- Cullman Clinical Trials
-
-
Florida
-
Bradenton, Florida, 미국, 34209
- 모병
- DM Clinical Research-Bradenton
-
-
Minnesota
-
Maplewood, Minnesota, 미국, 55109
- 모병
- Headlands Research - Twin Cities
-
-
Texas
-
Tomball, Texas, 미국, 77375
- 아직 모집하지 않음
- DM Clinical Research-Tomball
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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).
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Berobenatide
Participants receive berobenatide by subcutaneous injection. |
Subcutaneous injection
다른 이름들:
|
|
위약 비교기: Placebo
Participants receive volume-matched placebo |
Volume-matched subcutaneous placebo. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change From Baseline in Apnea-Hypopnea Index
기간: Baseline, Week 52
|
Apnea-Hypopnea Index is the number of apnea and hypopnea events per hour of sleep, assessed by polysomnography. |
Baseline, Week 52
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change From Baseline in Body Weight
기간: Baseline, Week 52
|
Baseline, Week 52
|
|
|
Change From Baseline in Waist Circumference
기간: Baseline, Week 52
|
Baseline, Week 52
|
|
|
Percent Change From Baseline in Body Weight
기간: Baseline, Week 52
|
Baseline, Week 52
|
|
|
Percentage of Participants With Improvement in Patient Global Impression of Severity (PGI-S) Sleepiness Category
기간: Week 52
|
Week 52
|
|
|
Percentage of Participants With Improvement in Patient Global Impression of Severity (PGI-S) Fatigue Category
기간: Week 52
|
Week 52
|
|
|
Percentage of Participants Reporting Improvement in Patient Global Impression of Change (PGI-C) Sleepiness
기간: Week 52
|
Week 52
|
|
|
Percentage of Participants Reporting Improvement in Patient Global Impression of Change (PGI-C) Fatigue
기간: Week 52
|
Week 52
|
|
|
Percentage of Participants Reporting Improvement in Patient Global Impression of Change (PGI-C) Sleep Quality
기간: Week 52
|
Week 52
|
|
|
Percentage of Participants Reporting Improvement in Patient Global Impression of Change (PGI-C) Snoring
기간: Week 52
|
Week 52
|
|
|
Number of participants with Treatment-Emergent Adverse Event (TEAE)
기간: Week 52
|
Week 52
|
|
|
Number of participants with Serious Adverse Event (SAE)
기간: Week 52
|
Week 52
|
|
|
Number of participants with Adverse event (AE) leading to permanent discontinuation from study intervention or study
기간: Week 52
|
Week 52
|
|
|
Number of participants with Adverse Events of Special Interest (AESI)
기간: Week 52
|
Week 52
|
|
|
Number of participants with clinical laboratory abnormalities
기간: Week 52
|
Week 52
|
|
|
Change From Baseline in Low-density lipoprotein cholesterol (LDL-C)
기간: Baseline, week 52
|
Baseline, week 52
|
|
|
Change From Baseline in High-Sensitivity C-Reactive Protein
기간: Baseline, Week 52
|
Baseline, Week 52
|
|
|
Percent Change From Baseline in Apnea-Hypopnea Index
기간: Baseline, Week 52
|
Baseline, Week 52
|
|
|
Percentage of Participants With at Least 50% Reduction in Apnea-Hypopnea Index
기간: Week 52
|
Week 52
|
|
|
Change From Baseline in Sleep-Apnea-Specific Hypoxic Burden (SASHB)
기간: Baseline, Week 52
|
Baseline, Week 52
|
|
|
Percentage of Participants With Obstructive Sleep Apnea Remission or Mild Non-Symptomatic Obstructive Sleep Apnea
기간: Week 52
|
Week 52
|
|
|
Change From Baseline in Systolic Blood Pressure
기간: Baseline, Week 52
|
Baseline, Week 52
|
|
|
Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep-Related Impairment 8a T-Score
기간: Baseline, Week 52
|
Baseline, Week 52
|
|
|
Change From Baseline in PROMIS Sleep Disturbance 8b T-Score
기간: Baseline, Week 52
|
Baseline, Week 52
|
|
|
Percentage of Participants with AHI <5
기간: Week 52
|
Week 52
|
|
|
Percentage of Participants with AHI 5-14 with ESS (Epworth Sleepiness Scale) ≤10
기간: Week 52
|
Week 52
|
|
|
Percentage of participants with AHI less then 15
기간: Week 52
|
Week 52
|
|
|
Change From Baseline in Epworth Sleepiness Scale Total Score
기간: Baseline, Week 52
|
Baseline, Week 52
|
|
|
Change From Baseline in Impact of Weight on Quality of Life-Lite Clinical Trials (IWQOL-Lite-CT) Physical Function Composite Score
기간: Baseline, Week 52
|
Baseline, Week 52
|
|
|
Change From Baseline in IWQOL-Lite-CT Physical Composite Score
기간: Baseline, Week 52
|
Baseline, Week 52
|
|
|
Change From Baseline in IWQOL-Lite-CT Psychosocial Composite Score
기간: Baseline, Week 52
|
Baseline, Week 52
|
|
|
Change From Baseline in IWQOL-Lite-CT Total Score
기간: Baseline, Week 52
|
Score ranges from 0 to 100; higher scores indicate better quality of life. |
Baseline, Week 52
|
|
Change From Baseline in Body Mass Index
기간: Baseline, Week 52
|
Baseline, Week 52
|
|
|
Change From Baseline in Neck Circumference
기간: Baseline, Week 52
|
Baseline, Week 52
|
|
|
Change From Baseline in Short Form 36-Item (SF-36)
기간: Baseline, Week 52
|
Baseline, Week 52
|
|
|
Percentage of Participants With Improvement in Patient Global Impression of Severity (PGI-S) Snoring Category
기간: Week 52
|
Week 52
|
|
|
Change From Baseline in EuroQol 5-Dimension, 5-Level (EQ-5D-5L) Index Score
기간: Baseline, Week 52
|
Baseline, Week 52
|
|
|
Change From Baseline in EuroQol-visual analog scale (EQ-VAS) Score
기간: Baseline, Week 52
|
Baseline, Week 52
|
|
|
Change From Baseline in WPAI:GH Presenteeism Score
기간: Baseline, Week 52
|
Baseline, Week 52
|
|
|
Change From Baseline in WPAI:GH Work Productivity Loss Score
기간: Baseline, Week 52
|
Baseline, Week 52
|
|
|
Change From Baseline in WPAI:GH Activity Impairment Score
기간: Baseline, Week 52
|
Baseline, Week 52
|
|
|
Change From Baseline in Diastolic Blood Pressure
기간: Baseline, Week 52
|
Baseline, Week 52
|
|
|
Change From Baseline in Total Cholesterol
기간: Baseline, Week 52
|
Baseline, Week 52
|
|
|
Change From Baseline in High-density lipoprotein cholesterol (HDL-C)
기간: Baseline, Week 52
|
Baseline, Week 52
|
|
|
Change From Baseline in Non-HDL Cholesterol
기간: Baseline, Week 52
|
Baseline, Week 52
|
|
|
Change From Baseline in Very low-density lipoprotein cholesterol (VLDL) Cholesterol
기간: Baseline, Week 52
|
Baseline, Week 52
|
|
|
Change From Baseline in Triglycerides
기간: Baseline, Week 52
|
Baseline, Week 52
|
공동 작업자 및 조사자
스폰서
수사관
- 연구 책임자: Pfizer CT.gov Call Center, Pfizer
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- C6491021
- VESPER-OSA 2 (기타 식별자: Alias Study Number)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .