Phase 2 Study of Brenipatide Injection to Help Adults Stay Quit from Smoking and Prevent Relapse

What this Trial Is About

Researchers are evaluating the efficacy and safety of brenipatide compared to a placebo for reducing the risk of relapse to cigarette smoking in adults who have recently quit. The study is a phase 2, multicenter, randomized, double-blind trial focused on helping adults maintain abstinence from smoking. Participants are adults aged 18 to 75 years who have recently quit smoking and are motivated to stay quit. Participants are randomly assigned to receive either brenipatide or a placebo, both administered by subcutaneous injection. The study involves a 2-week screening period, followed by a 24-week treatment period where participants self-inject the assigned intervention. After treatment, there is an 8-week safety follow-up period to monitor participants health and any effects related to the study drug. Throughout the approximately 34-week study, participants are expected to attend up to 17 study visits. Researchers will measure the percentage of participants who achieve continuous abstinence from cigarette smoking, confirmed by carbon monoxide levels, from week 1 to week 24. Additional assessments include patient-reported outcomes, body weight changes, drug plasma concentration levels, and monitoring for anti-drug antibodies. Safety and adherence are closely monitored during and after the treatment phase.

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