A Phase 2, Randomized, Double-Blind Study Comparing Brenipatide and Placebo to Reduce Risk of Smoking Relapse in Adults Who Recently Quit

What this Trial Is About

Researchers are evaluating the efficacy and safety of brenipatide compared to a placebo for helping adults who have recently quit smoking avoid relapse. This phase 2, multicenter, randomized, double-blind study focuses on reducing the risk of returning to cigarette smoking. The study is sponsored by Eli Lilly and Company and involves participants aged 18 to 75 years who are motivated to stay quit from smoking. Participants will receive either brenipatide or a placebo, both administered by subcutaneous injections. The study includes a 2-week screening period, followed by a 24-week treatment period where participants self-inject the study drug or placebo. After treatment, there is an 8-week safety follow-up to monitor participants. The study involves up to 17 visits during the 34 weeks of participation. During the study, researchers will measure the percentage of participants who maintain continuous abstinence from smoking confirmed by carbon monoxide testing from week 1 to week 24, allowing for slips. Additional assessments include patient-reported outcomes, changes in body weight, pharmacokinetic measurements of brenipatide, and detection of anti-drug antibodies. Participants need to be reliable in attending visits and following study procedures, including self-injection. Safety monitoring continues throughout the follow-up period.

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