A Phase 2, Multicenter, Randomized, Double-Blind, 52-week Study to Investigate the Efficacy and Safety of Brenipatide Compared With Placebo for the Treatment of Adult Participants With Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD) (J2S-MC-GZMV)

未提供0 个研究点目标入组 606 人开始时间: 待定

适应症

试验速览

暂无简介。

•Have a physician diagnosis of Chronic Obstructive Pulmonary Disease (COPD), at least 12 months prior to screening who meet the following criteria:
•Current or former smokers with a smoking history of greater than or equal to (>=) 10 pack-years
•Moderate-to-severe COPD (post-Bronchodilator (BD) Forced Expiratory Volume in 1 Second (FEV1)/forced vital capacity (FVC) less than (<) 70 percent (%)
•Modified Medical Research Council Dyspnea Scale (mMRC-DS) grade >=2
•Exacerbation history of >=2 moderate or >=1 severe exacerbations within the year prior to inclusion.
•Background double therapy [long-acting B2-agonists (LABA) + long-acting muscarinic antagonists (LAMA)] or triple therapy [inhaled corticosteroids (ICS) + LABA + LAMA)] for 3 months prior to randomization with a stable dose of medication for >=1 month prior to screening.

•Have a known pre-existing, clinically important lung condition other than COPD.
•Have a current or recent acute, active infection before screening and up to randomization.

发起方

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