J2S-MC-GZMV
Research type
Research Study
Full title
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).
IRAS ID
1013904
Contact name
Tetiana Rudenok
Contact email
Sponsor organisation
Eli Lilly and Company
Research summary
Study J2S-MC-GZMV (GZMV) will evaluate the effectiveness and safety of a medicine called Brenipatide in adults with moderate-to-severe chronic obstructive pulmonary disease (COPD).
COPD is the name for a group of lung conditions that cause breathing difficulties including emphysema (damage to the air sacs in the lungs) and chronic bronchitis (long-term inflammation of the airways). It mainly affects middle-aged or older adults who smoke or used to smoke.
Study GZMV will enrol participants from 40 to 75 years of age who have been diagnosed with moderate-to-severe COPD and are current or former smokers. Participants will be assigned in a 1:1:1 ratio to receive either Brenipatide 0.75mg, Brenipatide 3.0mg or placebo (dummy treatment with no active medicine). This means there is a 1 in 3 chance (33%) of receiving placebo and a 2 in 3 chance (67%) of receiving Brenipatide at one of two doses.
The purpose of this study is to assess the safety and effectiveness of 0.75 mg and 3.0 mg Brenipatide compared with placebo, in people with moderate-to-severe COPD.
The study consists of a
8-week screening and lead-in period (to check eligibility and prepare participants for the study)
52-week treatment period, and
a safety follow-up period of approximately 8 weeks.
Approximately 606 participants worldwide, and 44 patients in the UK will take part in the study, which will run for about 16 months.REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
26/EM/0117
Date of REC Opinion
15 Jul 2026
REC opinion
Further Information Favourable Opinion