Clinical Trial

A Study of Brenipatide in Adults Who Quit Smoking Cigarettes and Want to Avoid Relapse

Study acronym: RENEW-Smk-1
Recruiting Phase 2
View on ClinicalTrials.gov →
Summary
This study evaluates the efficacy and safety of brenipatide when compared to placebo for reducing the risk of relapse to cigarette smoking in adults who have recently quit. Study participation will last approximately 34 weeks with up to 17 study visits, which includes a 2-week screening period, 24-week treatment period, 8-week safety follow-up period.
Protocol Amendment History 13 amendments
This ClinicalTrials.gov record has been amended 13 times since 2025-10-31; most recent amendment 2026-07-16.
Status change: Not Yet Recruiting → Recruiting 2025-11-21
Trial Details
NCT Number NCT07223840
Lead Sponsor Eli Lilly and Company
Conditions Smoking
Enrollment 222 participants
Start Date 2025-11-03
Primary Completion 2027-02 (estimated)
Study Completion 2027-02 (estimated)
Updated on ClinicalTrials.gov 2026-08-06