The main purpose of this study is to assess if different dose levels of Brenipatide are safe and work the way they are intended to work in participants with moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD), when compared with placebo. The study will last approximately one year.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
606
Change from Baseline in Pre-Bronchodilator (BD) Forced Expiratory Volume in 1 Second (FEV₁)
Time frame: Baseline through Week 36
Annualized Moderate or Severe COPD Exacerbation Rate Over 52 Weeks of Treatment
Time frame: Baseline through Week 52
Change from Baseline in St. George's Respiratory Questionnaire for COPD (SGRQ-C) Total Score
Time frame: Baseline, Week 36, and Week 52
Change from Baseline in Pre-BD FEV₁
Time frame: Baseline through Week 52
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
Physicians interested in becoming principal investigators please contact
CONTACT
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University of Alabama at Birmingham
Birmingham, Alabama, United States
NewportNativeMD, Inc.
Newport Beach, California, United States
Institute of HealthCare Assessment d/b/a Apex Clinical Research
San Diego, California, United States
National Jewish Health Medical Center
Denver, Colorado, United States
Millennium Medical Research - Miami
Miami, Florida, United States
Deluxe Health Center
Miami Lakes, Florida, United States
Florida Institute For Clinical Research, LLC
Orlando, Florida, United States
Axis Clinical Trials - Westchester
Westchester, Illinois, United States
Indiana University Health University Hospital
Indianapolis, Indiana, United States
IU Health Ball Memorial Hospital, Inc.
Muncie, Indiana, United States
...and 118 more locations