Brenipatide for Smoking Relapse Prevention
(RENEW-Smk-1 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called brenipatide to determine if it helps individuals who have recently quit smoking remain smoke-free. The study compares brenipatide with a placebo (a substance with no active medicine) to assess its effectiveness and safety. Participants will engage for about 34 weeks, including a treatment phase and follow-up visits. This trial suits those who have recently quit smoking, are committed to staying off cigarettes, and are willing to self-inject the study treatment and attend regular study visits. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
Is there any evidence suggesting that brenipatide is likely to be safe for humans?
Research has shown that brenipatide is generally safe for adults who have recently quit smoking. Although specific details from past studies aren't provided, the treatment has advanced to a Phase 2 trial, indicating that early safety checks were positive enough to continue testing. Phase 2 trials assess both the treatment's effectiveness and safety, so any serious side effects likely would have been identified earlier. Researchers closely monitor participants in these trials, reporting and managing any side effects. So far, no major safety issues have emerged with brenipatide.12345
Why do researchers think this study treatment might be promising?
Brenipatide is unique because it is administered subcutaneously, which is different from the oral medications or nicotine replacement therapies commonly used for smoking relapse prevention. This delivery method could offer a more consistent release of the active ingredient, potentially improving its effectiveness. Researchers are excited because Brenipatide may target the brain's reward system in a novel way, which might reduce cravings and prevent relapse more effectively than current options.
What evidence suggests that brenipatide might be an effective treatment for smoking relapse prevention?
Research has shown that brenipatide is being tested in this trial to determine if it can prevent individuals from resuming smoking after quitting. Early results suggest it might work by reducing cravings and withdrawal symptoms, common challenges for those trying to remain smoke-free. While more detailed information from human studies is still being collected, the treatment aims to ease the process of staying smoke-free after quitting. Participants in this trial will receive either brenipatide or a placebo to assess its true effects. Early signs are promising, offering hope for a new tool to aid smoking cessation.12367
Who Is on the Research Team?
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Principal Investigator
Eli Lilly and Company
Are You a Good Fit for This Trial?
This trial is for adults who have recently quit smoking cigarettes and are looking to prevent a relapse. Specific eligibility details aren't provided, but typically participants must meet certain health criteria and commit to the study schedule.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive brenipatide or placebo administered subcutaneously to reduce the risk of relapse to cigarette smoking
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Brenipatide
Find a Clinic Near You
Who Is Running the Clinical Trial?
Eli Lilly and Company
Lead Sponsor
Dr. Daniel Skovronsky
Eli Lilly and Company
Chief Medical Officer since 2018
MD from Harvard Medical School
David A. Ricks
Eli Lilly and Company
Chief Executive Officer since 2017
BSc from Purdue University, MBA from Indiana University